In the October 22 edition of The New Yorker, Michael Specter wrote a fascinating article about the growing and exciting science of the human microbiome, the ecosystem of ten thousand or so bacterial species that call each of our bodies home. The hype around this particular field of scientific and medical inquiry is intense: Specter quotes David Relman of Stanford Medical school as saying that right now we are in the “beautiful, euphoric, heady early period” of the field, and notes that each week seems to bring additional symposia, publications, and grants for new research. All of this is for good reason. Promising studies have indicated that microbial therapy (the intentional introduction of certain bacteria into the body) can be an effective treatment for some diseases, while other researchers have suggested that a variety of modern diseases (like asthma, inflammatory-bowel disease, and some allergies) may be tied to changes in the human bacterial ecosystem. In some ways, this isn’t news: as Dr. Douglas Archer noted in an FDA advisory committee meeting on probiotics over a decade ago, using food with live cultures to treat disease is a longstanding practice dating at least as far back as 76 BC, when the Roman historian Plinio advocated using fermented milk to treat GI infections.
Notwithstanding this long history, the buzz around probiotics is at an all-time high, and as with any promising development in medical science, the hype has quickly outstripped the research. The burgeoning market in probiotics has apparently quadrupled since the late 1990s, and anyone who’s owned a TV in recent years has seen the ubiquitous advertisements for Dannon’s Activia yogurt starring actress Jamie Lee Curtis. Those ads, which promised to ease irregularity, ran afoul of FTC regulators, who accused the company of exaggerating the health benefits of their product beyond what science had proved. FDA has also had to step up enforcement, as producers of probiotic products have made claims that their products can treat everything from the flu to respiratory infections and high cholesterol (for example, see here and here). Realistically speaking, and despite scientific optimism and public enthusiasm, it seems likely that for the foreseeable future the probiotics market will continue to look more like the largely unregulated dietary supplements market than the pharmaceutical industry, at least until the hard science has time to catch up with the fad.
Should this worry us? In a world where we have become accustomed to FDA punting on rigorous enforcement of illegal drug claims for dietary supplements with the honest admission that enforcement resources are limited and these products are generally useless but harmless, is it worth expending limited FDA enforcement resources to pursue businesses trying to cash in on the hype around probiotics? One argument that it is draws on the history of the very same pharmaceutical industry that scientists hope probiotics will one day be a part of. A legitimate, science-based pharmaceutical industry in this country could not thrive until FDA had the authority and the resources to impose an effectiveness requirement on drug makers. Before the agency did so, patent-medicine houses flooded the market with bogus remedies that undermined both consumer faith in medicine generally and the market for legitimate (but expensive to develop) products. If FDA regulates probiotics with the same hands-off, buyer-beware mentality it has adopted toward dietary supplements, we risk never seeing the fully realized science-based probiotics field that Specter’s article holds out for us. I don’t doubt that officials at FDA agree that rigorous enforcement of drug claims is desirable, either. The problem, as it so often is with FDA, is one of resources. And the solution, as it always must be, is in the hands of Congress.