Below is a report on a recent conference on one of our favorite categories of supplement–PROBIOTICS.
We aren’t surprised that prestigious scientific organizations like the New York Academy of Sciences devote their resources to spreading the word about Probiotics. Over the last 100 years, these “friendly bacteria” have been the subject of an enormous amount of scientific study, confirming their crucial role in maintaining the human body’s immune system. And we also know that many NYBC members over the years have benefited from use of Probiotics such as the Jarrodophilus line from Jarrow, or Florastor (Saccharomyces boulardii). For a full list of these Probiotics, with indications for their use and dosing recommendations, see the NYBC catalog at PROBIOTICS AT NYBC
Probiotics, Prebiotics, and the Host Microbiome:
The Science of Translation
Wednesday, June 12, 2013 | 7:45 AM – 6:00 PM /The New York Academy of Sciences
George M. Carter
This was a day-long series of discussions, with nearly 70 posters that brought together a variety of researchers, clinicians and, of course, pharma reps sniffing around for profits. And all about the horrors of–BACTERIA! Of course, some bacteria cause disease…but most of them not only don’t, but we need them to live. And there are indeed a lot of them!
These good ones, when they are found in the diet or as a supplement, are known as probiotics, such as acidophilus or bifidobacteria. They are found, for example, in yogurt or other fermented foods. Prebiotics, on the other hand, are substances that help to facilitate the growth of those good bacteria, but are otherwise non-digestible. They include fiber (soluble or insoluble) and agents such as beta glucans, inulin and oligosaccharides.
There seemed to be a general feeling of anticipation as our knowledge grows about the microbes we share—and depend upon for our survival. Various populations of microbes live in distinct communities on and in our bodies. Each bacterium has its own set of DNA, just like each of our human cells (except cells like platelets and red blood cells). All of our human cell DNA contributes about 25,000 genes. By contrast, if you add up all the “bugs” in and on our bodies, that figure runs into the MILLIONS of genes, recent estimates placing the number at about 8 million. And if you removed all the microbes from your body, aside from killing you, that entire amount of bacteria would weigh up to 3 pounds!
That collection of microbes and their genes and gene-products are known as the microbiome. This is a complex system of various species of bacteria that interact with the host (us) and other bacteria. They tend to form ecologies at various sites so that the crew found in your nostrils may not be the same as that found in the gut, the vagina, or on the skin, for example. And the patterns of bugs that colonize us are different from person to person to some degree—and even change over the course of a lifetime.
These various types of bacteria are categorized by their taxonomy. Taxa refers to the genus, species and strain of the bacteria; for example, you may have heard of Lactobacillus acidophilus, often found in enriched yogurts. “Lactobacillus” is the genus name and “acidophilus” is the species. These also may be divided into further subtypes known as strains, so one strain is L. acidophilus L1, used to feed cattle to reduce the amount of bad bacteria such as E. coli O157:H7.
And these bacteria are necessary for our survival. They perform a huge number of functions, including producing some vitamins, training our immune systems, blocking bad bacteria from growing, and even altering our moods. They communicate within and between species of bacteria, as well as with our body. Some of them may cause trouble, including Helicobacter pylori (ulcers) and Clostridia difficile (colitis). How best to treat a dysbiosis (=microbial imbalance on or inside the body) is evolving as we increase our understanding of the relationships and ecologies of these bacterial communities.
The alterations in the nature of these communities arise from the time we are born. If one is born by a Caesarean, one tends to get more of the microbes of the mother’s skin as opposed to the vaginal microbial system that the infant collects during a vaginal birth. Whether this has any longer term clinical impact remains unclear, though some evidence suggests that those born by Caesarean may be at higher risk of allergies or asthma. The microbiota tend to establish themselves as a more adult phenotype by the tender age of 2 or 3. Some researchers are developing models that look at similarities in the patterns of the microbes such that people are divided into 2 or 3 enterotypes.Although this attempt at classification is still evolving, it may help us see how an individual’s response to or problems with host bacteria can be understood and managed.
Indeed, some of the sessions focused on new discoveries of particular bacteria that appear to be associated with protection from certain diseases, or may be implicated in causing disease. One group discussed their findings of a putative association of Akkermansia muciniphilia with the development of diabetes, while others focused on patterns of the microbiome that might underscore a potential for obesity. Many of the sessions were devoted to research in mice, which was moderately interesting from an academic perspective. Others looked at the inter-relationship between probiotics and brain function as well as “gut feelings” (the gut containing what some have dubbed a second brain’s worth of neuronal innervation).
This raised some issues abouthow to study these agents in the context of a Food and Drug Administration that is at the least bureaucratically hostile to the study of dietary supplements and currently forbids them to be marketed as preventing, curing or mitigating diseases. Discussion was devoted to these challenges, but I think it failed to get to the heart of the matter, namely, that we need—VERY carefully—to address how to create rulemaking with regard to Investigational New Drug requirements that does not require an absurd level of documentation of safety for products ALREADY on the market and in widespread use!
Other studies in humans can avoid the onerous process of acquiring an IND by using a primary endpoint (what the study seeks to establish) that is more in line with either the supplement’s use as a “medical food” (a very narrow definition), or that seeks to improve outcomes to structure or function of the body (the currently allowed dietary supplement claim).
The frightening prospect, to me, was the pharma reps sniffing around, no doubt seeing how they can “capitalize” on and/or patent products to extract huge profits. The notion of “public-private” partnerships in this arena gives me the horrors as it usually means taking away access except for the wealthy. We’re talking about products found in yogurt that have been used for millennia!
Still, the day also had a couple of remarkable and straightforward studies. The most exciting was the work of a group who helped women in various nations in Africa to produce their own probiotics and yogurt. This had the added advantage of creating an economic opportunity for the women, increasing respect from male householders as they brought in income while also improving health outcomes. This was augmented even more by the addition of a powder of the dried leaves of Moringa, a plant that grows like a weed from South America, throughout Africa, South and Southeast Asia, and which has a good array of micronutrient vitamins and minerals. Not in huge amounts, but fairly comprehensive.
A speaker from Scotland, Mr. Burns, also discussed the kind of “grassroots” organizing that they undertook in Scottish hospitals to translate research into the public health sphere. The point of this exhilarating talk was how to get from the bench to the bedside—in short, he was promoting a very comprehensive strategy for creating awareness among physicians and others, working with district leaders and hospital administrators. Their efforts got them, for example, to adhere more closely to checklists for surgeries and pneumonia management. By requiring and getting more attention to these matters, they were able to successfully, and dramatically, drop death rates. Some of these programs have run now for over 10 years, and involve getting physicians and others to prescribe probiotics or prebiotics and actually use them in preventing C. diff. or better management of bacterial vaginosis,or management of HIV-related diarrhea!
It was a day packed with information and interesting people. I attended with Dr. Henry Sacks of Mount Sinai School of Medicine, with whom I have been working on a grant from the National Institutes of Health to undertake meta-analyses of various questions relating to the use of Complementary and Alternative Medicine (CAM) approaches to managing HIV disease and ARV side effects. We are finishing up work on our first two questions, the use of a multivitamin/mineral among HIV+ people, and the management of peripheral neuropathy with Cannabis sativa. Our next question, which we are now beginning to work on, is the use of probiotics!
For more information, abstracts and so forth, please visit the NYAS website.
 Any changes in IND rulemaking should be careful to avoid opening the floodgates to drug companies using such changes to weaken safety or oversight of new drugs, of course. Accelerated approval has been abused by the companies to push more drugs more rapidly onto the market that are NOT medically superior or addressing a desperate need as antiretroviral drugs were in the mid-90s.