This week, I was planning on writing about superfoods, those things we keep hearing and reading about and feel guilty about not eating, but as I was catching up on my emails and saw the special issue Consumer Reports (CR) just devoted to dietary supplements, I decided superfoods will have to wait a week.

The CR piece opens with the story of an infant who was born prematurely and was given a commercial probiotic in the nursery to prevent an intestinal infection that sometimes happens to babies born prematurely. The baby ended up dying…not because the probiotic failed to prevent the expected infection, but because the probiotic product he was given was contaminated with a fungus that multiplied rampantly and shut down his organ systems. Had you or I taken this contaminated product, we probably would not have developed this infection, that is, assuming our immune systems are working reasonably well. But premature infants are at an increased risk for being immune-compromised- having an underactive immune system and not being able to fight infection. This story was a kick in the stomach for me.

Several years ago, I was involved in a review of all scientific research ever done that looked at the safety of probiotics given to humans. What we found was that hardly any research is done on the safety of probiotics. Very few studies that look at whether probiotics are effective (do what they were asked to do) even try to determine whether they were associated with any adverse effects. Most studies that do try to ascertain safety report that the probiotics (usually mixtures of different bacteria and even, yes, fungi and often concocted in the investigators own labs, not commercial products) were not associated with any reported adverse effects. But the very small number of studies that do report serious adverse effects (even infection) are nearly always in immunocompromised individuals: very sick, hospitalized patients, usually the very elderly or the very young. Even healthy elderly folks and infants tend to have somewhat weaker immune systems than those of us folks in between the young and the old. Babies born prematurely are among the most immunocompromised!

I am not a pediatrician or an infectious disease specialist, and I am not aware of the current guidelines for prophylactic administration of probiotics to infants born prematurely (i.e., to prevent a possible infection). The evidence is very strong that using probiotics can prevent the condition the providers were worried about, but researchers who have reviewed this evidence admit that not enough is known about the safety for very small premature babies, the ones who are at the highest risk for having problems. And being as familiar as I am with the safety literature, I would not have advocated giving this infant or any premature infant a probiotic, at least not a commercial product that has not undergone extensive safety testing and received assurance of purity.

CR reported this story as a lead in to a piece on the lack of testing of probiotics and ALL commercial dietary supplements, not only for safety but for effectiveness as well. This includes vitamins, minerals, protein powders, fish oil, herbals….In some ways, the lack of testing of probiotics seems more egregious than the failure to test other supplements because probiotics, at least the ones you purchase in pill form (not in yogurt, for example) are actually not dietary supplements – they are living (or potentially living) organisms, classified as biologicals by the federal government. But dietary supplements can be just as unsafe, which is why you take them at your own risk. The senators and congress-people who stripped the Food and Drug Administration of authority to require PRE-marketing assurance of safety and effectiveness did so because their constituents believed their freedom was being robbed: freedom to try any treatment they wanted. I suspect there was some element of mistrust of “pharma”, even though dietary supplement companies are now at least as huge and wealthy as any drug company. Some folks have asserted to me that they should have the right to take whatever they want, but somehow, when safety is in doubt, these same people want to know why the federal government didn’t do a better job…I’ll let CR tell the rest of the story.