What to Do About the Probiotic Study That Didn’t Turn Out How You Hoped

Recently, Million & Raoult (2012) alleged publication bias in probiotic scientific literature. The scientists comprising the board of directors of the The International Scientific Association for Probiotics and Prebiotics responded to this accusation in an open letter, concluding that there is no evidence that publication bias is worse in the probiotic field than any other scientific field. It is true that many, if not most, studies on probiotics are company-sponsored. But if companies didn’t sponsor this research, it is doubtful much would get done. Small steps can be taken to provide protection against bias, such as publication of all human trials with probiotics, regardless of the outcome (a well-conducted null study can be just as informative to the scientific community as a positive study); registration of human trials before they are initiated to facilitate tracking of studies that might not be published and to discourage post hoc tweaking of study design; and clear disclosures when studies are directly sponsored by industry.

But I wanted to extend this to a call to companies to recognize the importance of a forthright approach to scientific reporting. Picture yourself standing in front of a circuit judge who is trying to decide if a lawsuit has credibility, or a FTC attorney trying to decide if your claims are fraudulent or a long-time consumer wondering if his confidence in your product is warranted. You want to be able to say that the science speaks for itself.  The study design was accurately described, the a priori outcomes were accurately stated, blinding was respected, the data were appropriately reported and that the principal investigators you engaged acted with integrity. Any other approach will leave your reputation tarnished and your motives questioned. Understand that not all studies are positive and that sometimes studies on effective products don’t show statistically significant benefits in a given study.

Numerous reports suggest that fraud in science is on the rise (The Guardian, New Scientist, European Journal of Clinical Investigation ). Let’s keep it out of the probiotic field.