Official: Probiotics Are Not a Harmless Panacea
Many health conscious people love probiotics. They fit between natural (always good, isn’t it?) And medical (should be good for your health). I get real hate emails if I write anything less joyful about probiotics. One charming gentleman called me “fake news” and told me to break free from my “pharmaceutical fog”, as if Big Pharma and other large corporations were not very fond of selling probiotics for money .
But the truth is, probiotics aren’t always automatically beneficial. A few weeks ago, we had a hint of one reason for suspicion . More recently, in several scientific articles and at an FDA meeting, doctors and researchers have discussed some of the unknown and potential harms of probiotics.
Why probiotics are (sometimes) helpful
Probiotics are microscopic living things that we use – usually by eating, drinking, or swallowing a pill – for their health benefits. Most of them are bacteria, but yeast and other microbes may well fit the description.
Our body needs bacteria and other microbes. The bacteria on our skin prevent other, more unpleasant germs from entering and causing problems. We have “good” bacteria in our mouth, nose, vagina, and almost every place where the body meets the outside world. Our digestive tract, especially the large intestine, contains a huge number of microbes, of which there may be more than the human cells that make up our body.
Research into our relationship with these microbes has increased dramatically in recent years. They produce the chemicals our body needs and vice versa. Hundreds or thousands of species live in our bodies, and they interact with each other like the species of plants and animals in a rainforest. We know that a healthy microbial ecosystem is essential for a healthy body.
The only problem is that we still don’t know how to define a “healthy” microbiome, and even less about how to change it.
“Probiotic” is too vague a term
Looking through Cochrane Probiotic Reviews a topic pops up. Researchers want to know all the time if probiotics are helping for a particular condition, but a solid and reliable “yes” is rarely obtained. More often than not, the studies are too small to say for sure, or they are not designed as they should, or half of the research in this area says yes and half does not.
It would probably be unfair to treat “probiotics” as if they were a single known entity. Consider our analogy with the gut microbial ecosystem in the rainforest. Now ask if “animals” can help the rainforest thrive. May be? Depending on which animals and how many, when and how you released them.
At an FDA seminar this week, doctors and researchers lamented that even when we know probiotics can prevent or treat disease, we don’t know enough to say that this strain, at this dose in these patients, would have that effect.
For example, probiotics can prevent a deadly infection called NEC in premature babies. But neonatologist Joseph Noy noted that 90 percent of probiotics used in neonatal intensive care units in the US havenodata to support their safety or effectiveness . Instead, formulations are selected based on what is available.
The same is true with probiotics used for other diseases: patients or doctors decide that they should use a “probiotic” and choose from those available from their suppliers or in the store. But if their brand of choice has a different strain or dose than the one that worked in the study, there’s no reason to expect you to get the same results.
Bad things can happen
Probiotics seem to be relatively safe, but it’s hard to say for sure. Elaine Petrof , a physician and researcher who also spoke at the meeting, noted that probiotic research almost certainly underestimates the “side effects”, side effects, and harmful effects of probiotic treatment.
After all, probiotics are pills (or drinks, food, enemas) full of germs, and germs can make people sick. It is difficult to grow vats of bacteria and stuff them into tablets, being 100 percent sure that you only grew the bacteria you intend to grow and nothing else.
And manufacturers don’t always run enough tests to see what ends up in the pills. Peter Cohen, a professor of medicine who studies the nutritional supplement industry, wrote in JAMA Internal Medicine that supplement companies often violate FDA Good Manufacturing Practices, most often because they cannot confirm the “identity, purity, potency, or composition” of nutritional supplements. … final product.
In 2014, a premature baby died at the age of eight days from a rare fungal infection. Doctors traced the origin of the fungus back to a probiotic supplement that was given to the child from day one. The supplement was supposed to contain three known safe probiotic bacteria strains, but was contaminated with a fungus.
We do not know how often probiotics can be contaminated in this way. If you have diarrhea and take a probiotic in the hope that it will help, but there is something about the probiotic that makes you sick, you can simply assume that your original illness has worsened on its own, perhaps in spite of the probiotic. There is no standardized way to identify or report diseases caused by probiotics, but it is worrying that probiotic tests have shown that they sometimes contain species not listed on the label.
Probiotics can also be antibiotic resistant. This is not necessarily a bad thing, especially if you are taking them to reduce the side effects of antibiotics. But Cohen notes that some probiotics can pass on their antibiotic resistance genes to other bacteria they encounter, including potentially those from which you can get sick. Canada has banned probiotics that carry these types of antibiotic resistance genes, but has not yet done so in the US.
We are still studying how probiotics interact with our natural gut microbes.
Probiotic companies put a lot of emphasis on how important our gut microbes are to our health (really), which means we need to add good bacteria to our gut by taking probiotics, but that’s not exactly how they work.
Usually, probiotic bacteria do not live in our intestines. This doesn’t mean they don’t work; It’s possible they shake things up and then leave when the job is done – Clint Eastwood characters in the microbial Wild West.
But the relationship is probably more complicated than that. First, researchers usually use stool samples to find out what lives in our intestines, but the bacteria in our feces are not necessarily the ones that live on the inner lining of our intestines. It is easy to collect stool samples, much more inconvenient when a volunteer (or experimental animal) undergoes a colonoscopy to analyze what is going on deep inside. Much of the research on the gut microbiome relies on these not necessarily reliable stool samples.
Now, two recent Cell magazine articles are challenging the case. Both found that probiotics interact with our natural microbes in complex and possibly harmful ways.
In one study, people took antibiotics and then researchers tracked how long it took for their gut microbes to bounce back. Many of us take probiotics along with antibiotics to mitigate the effects, such as diarrhea that occurs when antibiotics kill our natural flora. But in this study, the researchers were able to show that probiotics make it harder for the intestines to return to normal.
Another study by the same research team found that some people are “resistant” to probiotic colonization, while others easily allow probiotic strains to settle. This suggests that the effects of probiotics can vary from person to person, not just the condition you want to treat.
Assuming probiotics need to be individualized, this is not too much of a jump from these results. But the researchers behind the studies also provide personalized catering services, so I’m a little skeptical about that.
Probiotics are trapped in a strange space that the government doesn’t know how to regulate
If you walk into a store and buy probiotics packaged in pill form, they will have a label that reads “Supplement Facts”; the government considers them a supplement, like vitamins. A supplement cannot say that it cures, prevents, or cures any disease, but it can make vague statements such as “improves the health of the digestive system.”
If you buy the same bacteria in food, such as yogurt or Yakult , it is considered just food. After all, bacteria are a normal component of yogurt.
But a dose of beneficial microbes can also be medicine. If you have a digestive disorder such as the infamous Clostridium difficile infection, you can ask your doctor to prescribe a treatment that contains bacteria from someone with a healthy microbiome. This treatment is made from the stool of a healthy donor and is best known as fecal microbiota transplant or FMT (even if it is delivered as dried material in tablets). In this case, the FDA considers the bacteria a cure. (They reportedly considered classifying this as a tissue graft, but bacterial cells are not part of the donor like blood or tissue donation.)
The difference is that something is a medicine if it is intended to cure, prevent, or cure a disease. If you would like to take probiotics while taking antibiotics, you can buy the supplement at the grocery store (with the caveats mentioned above, of course). But if a pharmaceutical company wants to sell a specific strain and dose of probiotics to prevent antibiotic-related diarrhea, it will need to get that probiotic drug approval, with all the paperwork and clinical trials that come with the drug’s application.
This is partly why the FDA held its recent meeting; they are trying to figure out what probiotic drugs will look like and what tests and labeling they should require. But so far all this is unknown.
Bottom line: the unknown will remain unknown for some time.
The only thing that is likely to improve in the near future is labeling adjustments: The FDA is asking manufacturers to add CFUs to labels . CFU, or colony forming units, roughly determine the number of living microorganisms in a product. Many FDA speakers stressed that labels also need to indicate the specific strain of bacteria they are using, not just the name of the species. (Like dog breeds, bacteria can be of different species, but still remain the same species.)
But everything else remains unknown. Does the probiotic product contain exactly what the label says and no more? Will it help? Will germs in a food starve to death in my gut if I don’t eat certain foods?
Is it harmless? Has this been tested on people like me? Many trials rule out people with weakened immune systems or digestive problems, even though these are the people who might benefit the most from probiotics or FMT.
But you don’t learn any of this from probiotic company marketing. Meanwhile, probiotics are the favorites of nutritionists, chiropractors, and other experts – both real and charlatans. The evidence is plentiful, and we know so little about the risks that it’s easy to forget they even exist.
There is also the huge problem that just because one probiotic works for one disease does not mean that all probiotics work for every disease. There are hundreds of probiotics, and of course, not all are suitable for everything.
We, as a society, have some pretty tough times when we understand the vitamins for cream. This is a certain amount of substances, we know that without them you will die, we have their special molecular composition, and we can produce them at will. We know what doses will prevent and treat diseases. Yet people still cannot follow the rules, when and whether you need them. For example, insomnia is one symptom of magnesium deficiency, which is why there are people selling “anti-stress drinks” with magnesium to help you sleep. This is bad logic – most people are not magnesium deficient, but it is for sale.
Probiotics have the same potency as vitamins, but have more vague scientific backing. Of course, some of them are safe and some are effective, but which ones? It will be a while before science has any definitive answers.