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Ep. 141: Are Microbiome Tests Legit or Fraud? with Robyn Openshaw


Robyn Openshaw, MSW - Jul 24, 2019 - This Post May Contain Affiliate Links


Vibe with Robyn Openshaw

Today we’re getting back into fine-tuning our critical thinking skills and taking a good look at the validity of microbiome tests: Viome, Ubiome, 2ndDay, etc.

Warning: This is a somewhat graphic topic because I say the word “poop” a lot. 

These up-and-coming companies that test your poop for inferences about the microbiome claim you can know specifically what to do and eat and how to live based on your fecal matter alone. So put you critical thinking caps on and come join me in a deeper look at our microbiome to decide for yourself what it all means.

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EPISODE HIGHLIGHTS:

  • [03:16] Should I get my microbiome tested? The microbiome wasn’t heard of until 20 years ago, yet some companies are assured they can test yours and give you all the answers to your health questions… via a poop swab.
  • [05:22] We change every day. Our microbiome changes depending on what we eat. Standard-of-care doctors push medication that change our microbiome in addition to that; what are the testing consequences?
  • [7:54] Where’s the science? The scientific evidence behind the microbiome testing is thin at best, and nonexistent at worse. Remember, correlation does not imply causation.
  • [16:32] Something smells rotten… The behind-scenes dealings between the microbiome companies and their founders have cause to be suspected; based on their promises, should investors or you be handing over your money? A little history lesson from Silicon Valley.
  • [31:04] What’s the verdict? The test results from two companies don’t line up, even with an exact sample. The nutritional science is almost nonexistent; a UC Davis professor says it best.

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TRANSCRIPT:

This transcript has been edited for clarity.

Robyn: Hey everybody, it’s Robyn Openshaw here at the Vibe show, and welcome back!

Remember that, not long ago, I did a three-part series that started with episode 110: How to Smell a Rat in the Health and Wellness Industry. Episode 110, 111, and 112 were all about using your critical thinking skills to know what’s best for you.

In those three episodes I went through how I look at research, how I evaluate the hierarchy of evidence so you’re not buying in hard on something that there’s actually very little evidence for.

Today I want to talk about a fad that’s going on right now that I’m concerned about. We’re going to deep dive into the microbiome tests.

We’ve talked about a bunch of bogus stuff in an age where anybody can market anything; the internet has opened wide the amount of information you’re being exposed to, some of which is really valuable and exciting, and it’s great that you have more access to more information. But it also means you’ve got a lot more to sift through, and there’s a lot of bogus things that you could be wasting your money on.

I would love to help you with sifting through what’s worth your money and what’s not.

I will be talking about some caveats today about the microbiome tests, and then I’m going to do another episode later, probably the one right after this, about what the ethical implications are and the loss of privacy issues in genetic tests, like 23andMe.

I think people get excited about [these genetic tests] and they want to be connected to long-lost half-sister across the world, or they have these romantic ideas about what’s going to happen when they do them. But what happens when what just recently happened, where companies like 23andMe sells all your data to a pharmaceutical company?

Today we’re talking about something I’m going to be sort of graphic about and call “the microbiome poop tests.” Because that’s what they’re testing; they’re testing your poop.

All of this is right on the heels of (I’m going to create a parallel here) this news story that you’re probably aware of, Elizabeth Holmes. She started a company called Theranos about thirteen, fourteen years ago, and she raised – wait for it – seven hundred million dollars for this company that she dropped out of Stanford to found. There’s podcast about it called “The Dropout,” I haven’t listened to it but it’s trending right now in iTunes; I think there’s a documentary about it, somebody is writing a book or has released a book about it.

You’re getting my opinion here; I can’t prove to you that some or all of these microbiome-testing companies are frauds, but I do think that they are frauds. Or they are built on shoddy science at best. They’re making inferences that are not scientifically grounded or supported with evidence, and I will share with you today why I think that.

In case you’re thinking of getting your, quote-unquote (I’m doing air quotes, just imagine me doing that) “microbiome tested” by sending your poop into a lab, keep in mind that nobody had ever heard of the microbiome 20 years ago. And really, for laypeople and even most physicians, it’s been only the last few years. It’s a tiny, tiny speck on the timespan of science, on its history of understanding what’s going on in the gut.

 

Microbiome Testing

These tests, which are, in order, probably the most well-known are Viome, uBiome, and 2ndDay. I assume that 2ndDay is an allusion to the fact that you eat it today and you poop it out the second day; that’s pretty gross but this whole episode is going to be a little bit gross.

All [of these companies] have the same claim that, based on a poop swab, or we could call it a fecal swab, they can give you a personalized prescriptive diet based on what your poop says to them.

I dispute that your poop test has the ability to dictate your ongoing diet, or even your short-term diet, and I cannot find any peer-reviewed research to support this claim. And, they say that these tests can be predictive of your personal disease risk. While there’s at least evidence regarding that, and there’s at least correlation, I dispute that too. I dispute that there’s a causative relationship there, the idea that a poop swab can tell you much at all about your disease risk besides some generalities.

I will acknowledge though that the only thing they can probably diagnose with accuracy from a swab of your poop is whether you currently have some very specific, active bacterial infection that day that you got the poop sample. And frankly you can probably find that out a lot better with other tests, tests that don’t involve you doing something with your poop besides what you want to do with it, which is of course flushing it.

Most of us at any given time – and this is a caveat against the one thing that I’ll allow that a poop swab can do – most of us are fighting a low-grade infection or virus at any given time, which our body will probably manage if we are healthy.

One of my employees recently found out through some testing at her functional medicine clinic that she had a low-grade infection, according to her bloodwork. Keep in mind, she was not ill. But her functional medicine doctor, of all people, wanted to put her on antibiotics. I couldn’t believe it. The infection wasn’t causing her any known symptoms.

But when our functional medicine doctors are prescribing us preemptive antibiotics, we know that the line between functional medicine and standard-of-care medicine, or the drugs and surgery approach, are getting very blurry. These are the old tactics of stand of care doctor, the ones that have a pill for every ill and they completely ignore the consequences of the drug prescriptions.

I was just talking in a Facebook page this week, in a private Facebook group with lots of functional medicine doctors, about how women with hormonal problems are almost routinely being put on the pill these days. Whether or not they’re at risk for getting pregnant or having unwanted pregnancies, they’re put on the pill. That could not be more misguided.

Again, this is what standard-of-care doctors do; make sure you are aware, if you go to one of these doctors, the M.D.s, the ones your insurance pays for, the ones in the networks, and keep in mind they will give you solutions like this. Nothing could be worse for your hormones than to take the synthetic chemical known as The Pill.

Back to the microbiome poop tests. It’s really premature in 2019, or anytime soon really, to think we have enough information about our gut bacteria that we can use it to be predictive of many, if any, diseases.

If you get your poop culture back and they tell you, “you don’t have a wide swath of probiotic cultures in your gut based on what your poop says, and you’re vulnerable to lots of infectious illness as well as potential chronic diseases, such as cancer,” there’s no evidence that banning certain classes of foods – and this is where they’re going to go – can be inferred from one of your poops. That particular poop that you sent into the lab might be indicative of what’s in your gut right now, but this changes dramatically day to day, and week to week.

One of these companies, uBiome, is in big trouble right now, and that’s what made me think, “I need to do a podcast episode on this.” They recently got raided by the FBI and the two founders got sent home. They’re in trouble right now for billing issues with two of their tests: SmartGut and SmartJane. They’ve been disabled; they cannot use them while the FBI figures this out. The two founders are not allowed on the property, they’ve been put on administrative leave while the investigation is going on.

The issue is not about whether what they’re doing is even legitimate (I don’t think the FBI digs into whether this is based on real medicine or real science), the fraud they’re being accused of is insurance fraud. There is one test that you can still buy from uBiome called Explorer, you can do it at home without a doctor’s involvement. You can test five different areas and it’s $89 per area tested, or you can pay $399 for all five. It’s testing your gut, nose, oral, skin, and genital microbiomes.

It is interesting that we are now able to study the microbiome of the skin, the microbiome of the nose, of the mouth. While that is interesting, my main argument here is that we don’t have the data to make many inferences from that.

There’s a guy named Jack Gilbert, who is the faculty director at the Microbiome Center of the University of Chicago. He says that many studies had been done, or are being done, on the microbiome in very small groups of patients, but that “all we have is evidence of correlative relationships.” Not causative relationship. For example, a lack of diversity in the types of bacteria in the gut is thought to be associated with a bunch of different kinds of diseases.

But the fact is that if you tell me you have chronic constipation or diarrhea, if you tell me you have chronic gas and bloating and difficulty digesting food, I can infer from that – without you sending a poop swab in and paying somebody $400 – that you don’t have the diversity of microbes in your microbiome.

I can also tell you that there’s a lot of published research, that is not based on one bowel movement that you had, that tells us that eating a much higher fiber diet, and getting some good probiotic-rich foods in your diet, is a good idea.

This is the level of advice you might get from one of these companies that would actually be valuable (and by the way, they don’t give you information like this) but guess what? You can already infer both of those pieces of advice just from those symptoms.

 

Microbiome Testing or Nutritional Changes?

If you told me that you took a lot of chemical medications, especially if you took antibiotics, especially if you used NSAIDs – nonsteroidal anti-inflammatory drugs – like ibuprofen and Aleve, I would be able to infer from that that you have probably caused wide swaths of healthy bacteria in the microbiome to be killed off. I would infer those same truths based on whether you got a poop test or not.

What I’m saying is that it’s really tempting to think that, “My microbiome is so special that I need a special diet based on what a lab tells me, a different diet than everybody else.” It’s exciting, and magical, to think that, “whatever my poop says about me should dictate everything I eat for the next year.” But truly I think this is wishful thinking and not something worth your dollars at this time.

I’m not the only one concerned that we know a lot less about the microbiome than you might think, and that it’s premature to say that anything we learn from a poop test could ethically be used to prescribe you a highly-personalized diet, or sell you supplements. Because you know they’re going to sell you supplements, right? You know that that’s in the plan for these microbiome poop-testing companies, to sell you supplements.

As I was researching to do this (because I had my own opinion on it but wanted to do a deeper dive) I spent quite a bit of time looking at, what is everyone else saying? What published evidence is there? Could I be wrong? Could I be a lot wrong, could I be a little bit wrong; are there peer-reviewed articles linking specific prescriptive diets to whatever anybody finds in a poop swab?

I couldn’t find a darn thing, to be honest. Not even on the websites of uBiome and Viome, those two biggest companies that do the microbiome testing. I found PhD researchers who had similar concerns to mine, and some of them have been full-time studying the science of the microbiome. They too are sounding the alarm bell about these companies. And why is that? Why should these companies not be jumping the gun? Because, like I often say, correlation does not imply causation.

It’s a very basic tenant of data; it’s a logical fallacy to think that because two things are correlated, one thing caused the other. If you get a test on your microbiome done, how much of that [advice you’re given] can you really value? With these tests, and with the current state of knowledge about the microbiome so up in the air, so very early in this emerging science, there’s no evidence anywhere that I can find that eating X,Y, or Z food will have A, B, or C effect in the complex, multifaceted microbiome.

We do know that eating starchy foods, or foods high in prebiotics, give rise to a broader variety of these healthy organisms, or probiotics. We also know that some disease states like Parkinson’s, or gut disorders, are correlated with very low diversity in the microbiome. But just because those two are correlated does not mean that one caused the other. Maybe you have low gut microbiome diversity because you have Parkinson’s. Maybe you have Parkinson’s because you have low gut microbiome diversity. Or maybe both are caused by the same thing and they are both symptoms.

About these companies though, I’m really amazed that investors have given them tons of money. It feels like the “.com” bubble to me in the early part of this century. It makes me wonder if these investors have heard a great pitch from these people starting these companies, but maybe these investors know very little about nutrition and how the science of the microbiome is so very young. And how little we are really going to be able to do to correct major microbiome imbalances with what these companies want to do.

Maybe you can address the microbiome imbalances – I know you can – but I’m not sure it’s going to be monetized by these companies that have raised tens of millions of dollars in order to be able to launch.

I’m going to tell you what some of their activities have been, and I think you’re going to be just a skeptical about them as I am. Bottom line is, the main way we know how to increase the diversity and quantity of bacteria in the gut is to eat a whole-foods (95% plus) plant-based diet, with a lot of starchy foods.

My main point here is that I think we should stay grounded in the basics, rather than chasing some expensive and entirely theoretical tests on today’s poop to dictate what we should eat for life.

One microbiome expert that I found in my research says that it might be possible to find out how the microbiome is affecting a specific’s person’s disease, or make dietary recommendations, but that it would require much more data, and monitoring over several years. To do that, a company would have to charge five or six thousand dollars.

One of these companies that you can get the poop testing done from even has a subscription program, where you can send your poop in once a month for $59.95. Sounds fun, right? (I don’t think this is particularly useful, either).

 

Microbiome Testing: Founder Hoax

Let me tell you about Viome: I think it’s a big hoax too. I’ll probably get in trouble for saying this, because some of my colleagues will listen to this and they’ll be mad that I said this, but the founder of Viome – I won’t say his name, you can do a little googling if you have a deeper interest in it – has a long history of hoaxing people and bilking investors of billions of dollars (again, I’m not going to say his name, I don’t particularly know him, met him once but don’t know him, I don’t have a dog in this fight). Wikipedia goes into detail about his past with insider trading with a company called Moon Express, with a company called InfoSpace.

He was accused of and had lawsuits against him for deceiving the public by making a company appear far more successful than it actually was, that company being InfoSpace. That same founder founded Viome and has raised, from what I can tell, forty-five million dollars in funding.

Now, Viome has recently acquired a personalized nutrition service call Habit from, wait for it, yes, a processed food company called Campbell Soup. You’re all familiar with Campbell Soup. What is Campbell Soup doing, owning a software that spits out personalized nutrition advice and selling it to poop doctors at Viome earlier this year for an undisclosed sum?

The way Viome works – I’m going to talk about what all these companies have in common, there are plenty of critics if you start looking for them – you’re supposed to drink a nutritional shake. We couldn’t actually find the ingredients online of this nutritional shake you’re supposed to eat. And the next day, when you poop out the nutritional shake, you send in a swab of your poop and they send you back recommendations.

Well guess what we found out? We couldn’t find ingredients of [the shake], so we wrote the company and they wrote us back saying they don’t even use the drink anymore. They just have you eat whatever, and send your stool sample in.

This doesn’t sound like any sort of settled science, or even useful science, when they’re changing the whole protocol for testing so radically within one year. And I think they’re looking for ways to monetize it and give you medical advice based on what your poop says. That seems to be the way they’re doing that.

The founder of Viome, back when he founded InfoSpace, he was sued by many people and then he sued a bunch of people in this big scandal back in the whole Silicon Valley “.com” bubble. He started up the company, they raised a ton of money without having any profit to show for it (does this sound familiar?) and then InfoSpace played some accounting games and claimed they made close to fifty million dollars in profit.

It turned out that they actually lost two hundred and fifty million. They lost five times as much money as they had claimed they made.

With that, and many other sketchy financial dealings, the founder himself sold tens of millions of shares at its peak. And then of course, investors sued him. You can read all about that on Wikipedia yourself, I didn’t make this up, I researched it myself. But the point is, he’s raised forty-five million dollars in funding for Viome, which looks to me like a whole lot of promises and sizzle, like InfoSpace was, with little substance.

We don’t know how much they paid for this personalized nutrition service that’s based on artificial intelligence to tell you what you should eat, based on what kind of bacteria are in your poop from one day.

With uBiome – the other big one, that’s in trouble with the FBI – I went to their science page, which tells you how many patents they have, and how many they have pending. That doesn’t really tell me anything about their efficacy, or the validity of their testing, or the validity of the recommendations they make based on the testing.

They do have a list of their press releases — also doesn’t tell me anything about their validity. They have papers their employees have published, which appears, to me, to be correlating specific microbes with specific health conditions. Again, correlation doesn’t imply causation.

What about Viome? What was I able to find out about Viome? Well, again, they used to – until very recently – send you a nutritional shake and then have you send in the poop that resulted from that. Now they don’t do the nutritional shake, so they don’t have any controls in place of “Everybody who did the test ate the same food.” That’s gone out the window. And they don’t even pretend to explain what the science is behind their methods.

You can go to it yourself and see if you come to a different conclusion that I do; it’s at ubiome.com. Well we’re back to Viome now but ubiome.com/science. You can learn more.

The way uBiome seems to work, what they will tell you, is that the 16S technology takes a small sample of freshly-wiped toilet paper and amplifies one particular sequence of DNA: the 16S RNA gene, found mainly in bacteria, and from that they are inferring the high-level makeup of your microbiome.

One of the experts who is trying to deconstruct what Viome is doing says, “Viome’s website boasts a long list of peer-reviewed scientific articles that helped make Viome possible, but look closer and you’ll see the details are generic publications from unaffiliated researchers with no hints of the methods used by Viome itself.”

The fact is, Viome won’t give you any of the science, or any documentation for its specific methods, because it says it’s all proprietary. That, for me, is a big red flag. It’s like saying, “We could tell you, but then we’d have to kill you.” Or, “We would tell you, but then our competitors would steal our trade secrets.” Which makes no sense, because if it’s proprietary they should just patent it and then nobody could steal their trade secrets.

Are you seeing the connection here to Elizabeth Holmes? Let me tell you a little bit more about this company called Theranos that she founded at the age of 19. The whole premise behind it was saying they could take a drop of blood, a pinprick test, and they could tell you anything you ever needed to know about your health. From a pinprick; a little spot of blood.

And you know what? People gave her seven hundred million dollars to fund this. The whole thing was a sham. The machine didn’t work; it was a total joke. Supposedly, she was worth 4.5 billion dollars. Feels very similar to the whole Silicon Valley “.com” bubble doesn’t it? She was on the cover of Forbes! She was named one of the most influential people in the world. Only problem was, the whole thing was fiction.

It was entirely theory: the prototypes were a mess; they were silencing the employees who were seeing what a complete disaster the whole thing was. They were even going out to Walgreens I think it was, rolling out the machines; it wasn’t working for anybody, and the whole thing fell apart overnight when it became obvious that the whole thing was the emperor’s new clothes.

Elizabeth Holmes created a lot of buzz and a lot of excitement; she raised hundreds of millions of dollars for 12 years, she was jet-setting with Bill Clinton and hiring teams of people and spending and was constantly in the media and giving inspirational talks. She was the darling of Wall Street; she was the female prodigy from Stanford engineering school after she dropped out. And it was a total fraud.

I honestly think these microbiome tests are about as proven, and about as useful, as the Elizabeth Holmes fake blood testing promises. If I’m wrong about this I’ll be the first to eat crow; if you send in a poop swab and they tell you what to eat and what supplements to take after that and you solve your health problems with it, write me. I want to know. I’m going to ask you questions; I want to know.

But I’m going to say to you that, right now, with what I’m able to find online from these companies – what they publish to their customers, to their shareholders – I believe it’s the perfect case of the emperor’s new clothes and it will be the next Theranos.

I don’t know why more people aren’t screaming about this out there on the internet, but that’s my two cents. I had to work pretty hard to find anybody who’s even criticizing these companies, but I personally don’t think you should wipe your butt and send the tissues into a lab.

If you want a little bit more detail on what they’re trying to do, here’s what I can figure out: the company collects a stool sample from you which you send in, and they run it through a software program to analyze what microbes are in your gut and then theorize what those microbes are doing to the food you eat.

“How your microbiome is treating your food can indicate,” says the founder of Viome, “what diseases you might be susceptible to.” What I’m inferring from this is that it’s all so specious, so theoretical, so built on nothing more consumer confidence rather than any proven science, that I don’t think it deserves the tens of millions of dollars investors have put into it, and I don’t think it warrants the $399 to send in your poop and then follow their advice.

 

Microbiome Testing’s Nutritional Advice

Viome will tell you that there’s no universal diet. Spinach, for example, might not be healthy for everyone because of the way your body processes it. By doing [the test], the founder and Viome claim, it can help you avoid getting diseases like diabetes, or irritable bowel syndrome, or even insomnia and depression.

Here’s the problem: spinach doesn’t cause cancer, or irritable bowel syndrome, or diabetes. It just doesn’t. If you have a problem with spinach, you have an underlying problem that causes the reaction to spinach, not the other way around.

Now, people with inflammatory gut disorders (there are more and more people like that, ironically likely from a poor diet for many years and medications that disrupts the microbiome), some people, a small minority, may be reactive to compounds in healthy foods.

But it does not then logically follow that then we need this guy’s poop meter and artificial intelligence to tell us we should eat an individualized diet that his test prescribes.

I don’t think what this calls for is some new artificial intelligence software to spit out what diet you should eat that they bought from the Campbell soup company.

When I was researching to do this episode, I found a guy that paid for both Viome and 2ndDay, which is another one of these companies that has sprung up in the last years to test your poop and tell you what to eat. And the nutrition recommendations for the exact same poop tested by two different companies (this won’t surprise you by this point in the discussion) was radically different. These are the two microbiome companies that didn’t just get raided by the FBI, by the way, and their founders told to go home and not go into the office.

Both of these tests, and the prescription for the diet that resulted, told the guy he should limit coffee and alcohol. So that’s consistent at least, but isn’t it also kind of a no-brainer that they should tell everyone? You certainly don’t need a poop test to be told to limit coffee and alcohol. But one of them told him he could go for it and eat lots of dairy and milk.

Milk is just bad for human beings period, so I take issue with this. Maybe if it’s organic, maybe if it’s cultured milk, and certainly for some, like African Americans, are far more lactose intolerant than Northern Europeans are (to some extent, I’m sure Scandinavians and Western Europeans and Americans have adapted to generations of eating the milk of another animal, or I guess drinking the milk), but it makes no sense to tell someone, “Go for it,” with dairy. Dairy is full of antibiotics, steroids, hormones, at best.

One of the tests told this guy, who was comparing results from the same poop from two different lab companies, that his microbes love light beer and that he should drink lots of it. I don’t get it. There’s nothing good in light beer, or beer in general.

Viome. When they combine the results of this nutritional challenge test – that they’ve now eliminated but that their website still says to drink this shake – with your gut intelligence poop test results – what they have on their site still even though they’ve disappeared one of those two things – Viome can then supposedly provide your ideal macronutrient ratio and make dietary recommendations that are unique to you.

They’re going to tell you how many proteins, fats, and carbs to eat based on what was in your poop. Just like everybody else in the diet-fad way of thinking that we talk a lot about on this show, these guys too are trying to get in on making money by telling people how many grams of proteins, fats and carbs to eat. It’s nonsense.

As I’ve said many times, how many grams of proteins, carbs, and fats we eat is not where the story of health is told. It’s far more about the quality, the specific sources of proteins, fats, and carbs, than breaking down how many grams. These poop-testing guys are showing how very little, or maybe not at all, they know about nutrition.

As I kept poking around, I found a professor from UC Davis whose looking at step 3 that Viome tells you to do. Step 3 is, “Next, you get actionable recommendations delivered right to your Viome App, so you can begin implementing your microbiome-shifting recommendations right away. You’ll know exactly which foods to eat, and which to avoid, in order to support your wellness at cellular and molecular levels. Viome allows you to retest and check in with your gut whenever you need to make sure you stay on top of your wellness goals.”

This is what the professor from UC Davis, Jonathan Eisen, has to say about that.

“The Viome material on Amazon in filled with completely misleading, over-selling of snake oil. In other words, they claim they can tell you exactly which foods to eat and which to avoid in order to support your wellness.”

It sounds like I’m not the only one, even though I believe that there’s a lot to come. There’s going to be a lot more people speaking up about this over time. But right now, they’re making a lot of money getting people to send their poop in along with a check for $400.

That’s my two cents, my next episode is going to be a part five of that three-part original series, “How to Smell a Rat in the Wellness Industry.”

This was all about the microbiome test; next time, let’s talk about the genetic tests: what you need to know.

[Related episode: Ep. 101: The Healing Power of Foods Interview with Dr. Michael Murray]

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