Probiotics stakeholders respond to 'frustrating' and 'confusing' 60 Minutes TV segment
The segment included comments from a number of academics, including Dr Jeff Gordon (Washington University in St Louis), Dr Patricia Hibberd (Boston University), Dr Dan Merenstein (Georgetown University), Eran Elinav and Eran Segal (Weizmann Institute of Science, Israel), and Dr Frank Greer (University of Wisconsin).
The segment dismissed the efficacy of probiotics and even raised doubts about the safety of the products, despite Dr Greer stating, “there's no evidence that says they're harmful”.
“The evidence is there”
Speaking to NutraIngredients-USA, Dr Merenstein said the interview took place over a year ago, so well before the American Gastroenterological Association released probiotics guidelines recently.
“The segment asked the wrong question,” said Dr Merenstein. “The question is not, ‘Do probiotics actually do anything?’ The question is, ‘What probiotic for what indication?’
“There were also a few red herrings in the segment, like the discussion by the Weizmann guys of colonization and the host speculating about a placebo effect, so that was frustrating.
“As far as I am concerned, the ship has sailed on this. The evidence is there. We may not all agree on whether there is a benefit for IBD, but nobody who objectively looks at the evidence argues about probiotics for antibiotic-associated diarrhea, or NEC or colic.”
IPA: “The program creates more confusion for consumers by not presenting a balanced piece”
In response, the International Probiotics Association stated: “A wide range of benefits of probiotics are broadly recognized by the health community. Probiotic effects are usually strain-specific, and well-characterized probiotics are safe for the general healthy population. In the US, probiotics may be foods or supplements according to the Food and Drug Administration (FDA), unless they come with a drug registration. However, the program did not reflect all of these factors and creates confusion and misimpressions in consumers by failing to present balanced information.”
IPA also commented on the comments made by Dr Hibberd that there is no evidence for the benefit of probiotics in antibiotic-associated diarrhea.
Probiotics are defined by the FAO/WHO as “micro-organisms, which when administered in adequate amounts confer a health benefit to the host”.
“The IPA would like to remind the reader that independent clinical organizations, such as the WGO (Guarner et al., 2017) and the AGA recommend specific probiotics (Su et al., 2020). For IBS, the WGO also recommends certain probiotics (Guarner et al., 2017). For allergies, a meta-analysis on the topic (Zhang et al., 2016) suggests a reduction of 22%,” stated IPA.
[There is also a prestigious Cochrane Review on probiotics for the prevention of pediatric antibiotic‐associated diarrhea, which concluded: “The overall evidence suggests a moderate protective effect of probiotics for preventing AAD.”]
Echoing Dr Merenstein, IPA also questioned the focus on colonization, which was raised by the researchers from the Weizmann Institute. IPA described the study as “technologically advanced” but noted that the product used was “undocumented”, “it included only a small number of subjects, and was not investigating any clinical endpoints.
“Just because the intervention did not recover the microbiota under the study conditions, does not mean that probiotics as a whole are ineffective (Suez et al., 2018). While the researchers were ‘surprised’ that the probiotics did not ‘settle’ (sic), it is important to understand that the scientific community widely acknowledges that probiotics do not colonize (Taverniti et al., 2019).
“The conclusion, in recommending caution with prescribing probiotics, is based on controversial results with a commercial product that is hardly documented as a probiotic,” stated IPA.
IPA continued: “In another interview, the efficacy and safety of probiotics in infant formula are questioned. In 2011, The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) concluded that there were no safety concerns in these populations (Braegger et al., 2011).
“It is always difficult to document a benefit in a generally healthy population, and this is also true for probiotic infant formulas. A further comment is made on the absence of long-term studies. One can discuss what long-term is, but the IPA would like to remind the reader that there are several longitudinal studies that have followed children from birth for 11 years or more (Wickens et al., 2018) and cancer patients for more than 20 years (Mutoh et al., 2020); none of which have raised safety concerns over these extensive periods.
“Dr. Gordon is right, the microbiota is a fascinating study topic, and we are indeed only now starting to understand what the microbiota means for us and the role probiotics can play. Probiotics can be, and are already, a part of health for many consumers.
“Dr. Merenstein, who is positive about the potential of probiotics, acknowledges the challenge for consumers to make sense of all the data presented to them. Unfortunately, the well-intended program by Dr. LaPook does not make this easier. The consumer will need more balanced sources of information to be able to make an informed choice.”
CRN: “The safety of probiotics is well-established”
Andrea Wong, PhD, senior vice president, scientific & regulatory affairs, at the Council for Responsible Nutrition (CRN), also weighed in on the segment, saying that it “pitted one scientist’s view against another's and leaving viewers confused about the category.
“The vigorous body of scientific research exploring the benefits of probiotics is providing increased understanding of the role probiotics play, not only for digestive health, but for immune function, brain health and even bone health,” said Dr Wong. “Probiotic use is supported both by a long history of safe use and rigorous clinical trials, and CRN underscores those beneficial effects and the safety of these products. But unfortunately, the recent news segment highlights the developing nature of the science and the lack of scientific certainty with regard to their beneficial health effects.
“Further, the segment questions the safety of probiotics and criticizes the regulation of these products. The safety of probiotics is well-established through their long history of use and safety studies. Moreover, probiotic products marketed as dietary supplements are subject to comprehensive dietary supplement regulations that include current Good Manufacturing Practices (cGMPs), testing procedures, labeling and storage requirements, and other practices enforced by regulatory agencies at both the federal and state levels.
“Many of the clinical endpoints questioned in the news segment involve treatment of serious diseases and medical conditions that are far beyond the purview of dietary supplements without refuting their beneficial effects for maintaining a healthy gut.”
Dr Wong concluded: “This segment and its featured research reinforces that probiotics work through a variety of mechanisms beyond changing the composition of the microbiome and we encourage more research into the benefits and safety of this category.”
