Sometimes we make the mistake of thinking that functional medicine is infallible; unfortunately, this is not the case. Today we will discuss how a fairly popular functional medicine lab was found to falsify lab ranges, a change which led to increased treatment recommendations, which were serviced by their sister company’s supplements. This story provides a good example for both clinicians and patients as to why a more conservative outlook on functional medicine is important.
Dr. R’s Fast Facts
- Hopefully none of this was performed with mal-intent and were simply honest mistakes or intentionally done with good intentions, but it does raise some serious questions and concerns for patients and practitioners alike.
- A neurotransmitter testing lab and affiliated supplement company; the lab tests and then recommends supplement company’s products.
- Civil and criminal investigation for violating laboratory testing requirements and manipulating testing data:
- Supplement company pleaded guilty to conspiring to obstruct administration of the CLIA program (Clinical Laboratory Improvement Amendments).
- CEO pleaded guilty to intentionally violating CLIA requirements.
- Admitted intentionally subjecting neurotransmitter testing to a “multiplication factor” that altered the results of the testing.
- Admitted conspiring to obstruct the administration of the CLIA program.
- Intentionally reported neurotransmitter test results as high or low based not on a properly validated reference range, but based on a narrowed range that had not been subjected to method validation.
- Then recommended products to patients that fell outside of this narrowed and invalid range.
U.S. Attorney Vaudreuil’s Statements:
- “Patients and their medical practitioners make critical health care decisions based on the test results reported by independent laboratories and it is crucial that laboratories report their results accurately and reliably.”
- “Intentionally subjecting test results to alterations and narrowed reference ranges that have not been properly validated violates a laboratory’s responsibility not only to the United States but, more importantly, to the public, and will not be tolerated.”
How Was This Exposed?
- Whistleblower action filed by a former employee.
- November 2015: “[same company] previously paid over $8.5 million to resolve separate allegations, brought by a different whistleblower.” https://www.justice.gov/usao-wdwi/pr/nutritional-supplement-provider-and-ceo-plead-guilty-false-claims-act-violations
- December 2015: “[same company] agreed that the United States could prove that: …[same company] falsely billed Medicare for ineligible food sensitivity testing for nearly five years.” https://www.justice.gov/usao-wdwi/pr/osceola-laboratory-agrees-pay-85-million-resolve-false-billing-case
What Does This Mean for Patients and Providers?
- Don’t assume just because you see a HIGH or LOW on a test value that it means anything.
- Testing and the patient should generally seem to match up.
- Always be looking to a test to tell you information that affects the course of treatment.
- This treatment should show an appreciable effect most of the time.
- Always question if what you are doing is truly needed – try to do less, RATHER than always striving to do more.
If you need help with functional medicine, click here.
Episode Intro … 00:00:42
The Dark Side of Functional Medicine … 00:01:57
Dr. Ruscio Resources … 00:08:38
Testing High or Low … 00:09:37
Heavy Metal Tests … 00:12:02
Testing and Patient Should Match Up … 00:13:40
Always Criticize Yourself … 00:17:30
Low-Validity Testing … 00:20:07
Episode Wrap Up … 00:22:10
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The Dark Side of Functional Medicine
A Supplement Company and a Lab Company Agree to Pay Over $6.1 Million to Resolve False Claims Allegations
Dr. Michael Ruscio: Hey, everyone. Welcome to Dr. Ruscio Radio. This is Dr. Ruscio, and today we’re going to be talking about the dark side of functional medicine and, unfortunately, how a supplement and lab company just agreed to pay over $6.1 million dollars to resolve false claims allegations. Looking forward to getting into these details.
Before we do, let me share with you how much of an idiot I am. I’ve been doing pretty well about curtailing my caffeine consumption, as we’ve talked about in the past. But today, I was feeling a little bit flat.
And I decided to walk over to Whole Foods, pick up a pre-made coffee. I picked up a 16-ounce Stump Town cold coffee in a carton, drank it, and as I’m walking home, I’m saying to myself, “Boy, I really feel jacked up. I wonder how much caffeine is in here.”
I checked the label, can’t find it anywhere, look it up on the internet. I’m assuming 100 mg. 398 mg in this thing! So I am admittedly a little bit short circuit-y right now. So I apologize if I’m a bit all over the map. I’m going to try to get through this coherently. But the show must go on.
The Dark Side of Functional Medicine
So the dark side of functional medicine. I’m not going to name any specific names. But I will put the links in here for the specific names of the companies if people want to dig into the details.
Let me preface this by saying hopefully none of this was performed with mal-intent and were simply honest mistakes or intentional maneuvers done with good intentions. But what we’re going to cover in a moment does raise some serious questions and concerns for both patients and practitioners.
Now, essentially a neurotransmitter testing lab and affiliated supplement company that report together—so if you come back with high or low X, Y, or Z neurotransmitter testing, you’re recommended to use X, Y, or Z nutritional supplement.
So a civil and criminal investigation was enacted for violating laboratory testing requirements and manipulating testing data.
The supplement company pled guilty to conspiring to obstruct the administration of what’s known as the CLIA program (Clinical Laboratory Improvement Amendments) and is looking at a maximum fine of $500,000 for that. And the CEO of the company pled guilty to intentionally violating CLIA requirements with a max penalty of over $100,000.
In the lawsuit, it was admitted to intentionally subjecting neurotransmitter testing to a multiplication factor that altered the results of the testing.
Also, there was an admonition of conspiring to obstruct the administration of the CLIA program, intentionally reporting neurotransmitter tests as high or low not based upon a properly validated reference range but instead based upon a narrow range that had not been subjected to method validation, then recommending products to patients that fell outside this narrow and invalidated range. So pretty heavy indictments here.
The U.S. Attorney General, and I’ll quote, had this to say. Of course, there’s an ambulance driving by. I’m just trying to enjoy a little bit of fresh air. Sorry about that, guys.
“Patients and their medical practitioners make critical healthcare decisions based on test results reported by independent laboratories. And it is crucial that laboratories report their results accurately and reliably. Intentionally subjecting test results to alterations and narrowed reference ranges that have not been properly validated violates a laboratory’s responsibilities not only to the United States but more importantly to the public and will not be tolerated.”
So these things are pretty serious. Continuing—a little bit of information on how this was exposed. This was actually exposed from the inside. A whistleblower action was filed by a former employee.
And this actually wasn’t the only time a former employee functioned as a whistleblower. There was this case, of course, but there was also a case not too long ago where this company paid over $8.5 million dollars to resolve separate allegations that were regarding ineligible food sensitivity testing.
So what we see here is potentially very disturbing. And it speaks to the fact that functional medicine may not be as pure as we sometimes think that it is. I think we like to think that functional medicine doesn’t suffer from some of the same perils that maybe conventional medicine does because there may not be the same level of corruption in different areas.
And this is not a criticism against conventional medicine, but I think we’re all aware of some of the pretty powerful indictments that have been made against the conventional medical system in certain areas where greed and corruption have influenced the system. It’s a sad reality. And I think the same thing holds true for functional medicine.
Why I think this is important is because it means that for patients or practitioners alike, you can’t operate in functional-medicine-land thinking that everything is all rosy. You have to have your feelers out. You have to have your BS meter on. You have to try to protect yourself.
I’m not saying to go into maybe a new doctor’s office who has been nothing but nice to you and all of a sudden have a jaded approach, but be a little bit aware of what’s going on.
And try to follow some of the tips, for example, that I recommended in our previous podcast. I think it was entitled, “How to Find a Good Functional Medicine Clinician.” If you follow some of those things, it’ll help you hopefully mitigate risk for something like this.
But essentially, this shows that, yes, it is possible for a lab to report fictitious lab ranges and cause people to think that there’s something wrong with them when there may not be and undergo treatment when there may not be anything wrong with them.
So this is important for everyone to be aware of because it’s really predominantly up to the healthcare practitioners and the patients to safeguard against this, in my opinion. I think improvements are more likely to come from the bottom up rather than the top down, and I just think that’s the way things tend to work better in general.
I don’t anticipate the people that own some of the companies to potentially self-regulate themselves out of profit because, unfortunately in some cases, it is more profitable to create a fictitious lab range where everyone or nearly everyone comes back high or low. And then everyone needs to be on the corresponding treatment for that.
Of course, this does not mean that every lab and every supplement company is out to get you. But there are some that, unfortunately, put profit before patients. And so I look to the doctors and the patients to understand this stuff as a safeguard against that.
And so this is important because it means that the practitioners and the patients need to be a little bit more educated about this to prevent feeding a potentially corrupt lab, in this case. And again, that’s assuming that it is corrupt. I think, based upon some of this litigation, that it’s pretty clear cut.
Dr. Ruscio Resources
Hey everyone. In case you’re someone who is in need of help or would like to learn more, I wanted to take just a moment to let you know what resources are available.
- For those who would like to become a patient, you can find all the information at drruscio.com/GetHelp.
- For those who are looking for more of a self-help approach and/or to learn more about the gut and microbiota, you can request to be notified when my print book becomes available at drruscio.com/GutBook – you can also get a copy of my free 25 page gut health ebook there.
- Finally, if you are a healthcare practitioner looking to learn more about my functional medicine approach, you can visit drruscio.com/review.
All these pages are at drruscio.com. URL – d-r-r-u-s-c-i-o.com then slash gethelp, gutbook, or review. OK, back to the show!
Testing High or Low
So I think we’ve already covered a lot of what this means for patients and providers. But a few other things I just wanted to outline.
One of the most important things—and we’ve talked about this in the past—don’t assume just because you see a high or a low on a test value that it actually means anything. And this is incredibly important.
And there are numerous examples of this. I think one of the most notable that we’ve discussed in the past is microbiota assays. And again, defining the microbiota assays or testing not as tests that fall underneath the umbrella of testing something in the microbiota, like SIBO, or testing for candida, or testing for H. pylori, or testing for Giardia.
These are all pretty well validated and tried-and-true tests that have pretty well mapped-out corresponding treatments for them. And everything here has been pretty validated and is on the up and up.
However, when you look at things like the ratios of firmicutes to Bacteroidetes, or you get a read out of your enterotype, or your diversity score, or you’re looking at all these different phylotypes, this is where there is really no clinical data saying this test dictates this treatment, or this finding can be treated in such a way.
We’re starting to see some preliminary evidence showing certain microbiota assays—one notably that’s out of Norway—correlate with disease. But we haven’t even gotten to the point yet where it tells you that you will do better with a corresponding treatment.
So this is very important because I see fairly frequently people coming in with a microbiota assay, thinking that it means anything. And they’ll have all these highs or lows. “Oh my goodness! My Lactobacillus acidophilus is low! My Prevotella corporis is high. And that’s supposed to be bad.”
Guys, those don’t have any clinical data in terms of, “Has there been a validation showing that this lab finding means you should do this treatment, and it can help you?”
So that’s important. It’s something that’s happening quite a lot right now. And it’s important that we understand that, while I believe anyone recommending those tests or participating in that sphere is doing so with the best intent, the evidence showing that that can actually help is not there. So this is something that I think needs to stop.
Heavy Metal Tests
There have also been similar criticisms made against certain companies for heavy metal testing. And I know I’ve talked about this before. We performed a pretty comprehensive review of the literature on metal testing.
And at some point, I promise I will go through that review. It’s just there have been so many other things that have been more important that I’ve wanted to get out ahead of that. But I think now that most of the book writing has been done and that huge task is off my plate, it’ll hopefully only be a number of months, maybe six months, until we release that.
But there are definitely some very overhyped and exaggerated claims regarding metal testing and metal treatment recommendations. It’s not to say that they can never be helpful, but I think they’ve been very much overstated.
What does that translate to? That translates to people performing tests that don’t need them, people performing treatments that don’t need to. And this results in functional medicine care that is more expensive and less effective.
So when we talk about this cost effective model of functional medicine, it’s realizing when to do something like a heavy metal test and when not to and if you, for example, should be incorporating a microbiota assay. Those two modifications could translate to thousands of dollars of savings, especially if you’re testing, treating, re-testing, and maybe even treating again.
So these things aren’t very hard to achieve in terms of the means to the endpoint of more effective functional medicine. It’s just simply doing these things.
Testing and the Patient Should Match Up
So testing and the patient should generally match up. And it’s something that, as a patient and as a provider, you should be looking to the test and how you feel to somehow make sense.
An example of this—and I think I shared this maybe in a podcast. If not in a podcast, I know I shared it in some clinical training webinar I did somewhere along the way.
There was a lab I was using for a while that reported anaplasmosis. It’s one of the Lyme family co-infections. And I saw a number of positives come back.
And at first, I was very excited because I said, “Aha! Here’s something that could be contributing to these people not feeling well. This is great. I’m going to treat this. And patients are going to get better. They’re going to love me. I’m going to feel good about myself. They’re going to be happy with their results. And yada, yada, yada.”
But what ended up happening was, as I looked at the typical presentation of anaplasmosis and what these patients were presenting with, they tended not to align more than they did align. So okay. That’s just something I’m going to make a mental note of and proceed forward.
Then I start treating people for this. And I don’t really see much of a response in most patients, if any. And then the retesting comes back. And these people still seem to be positive. And so after I saw, I think, three to five cases of this, I was pretty much convinced, “Okay, there has to be something wrong with this marker. This has to be suffering from a very high false positive,” meaning the test says the person is positive, but they’re not actually positive. It’s a false positive.
I think about six-ish months later, I receive a notice from this lab informing everyone that they were updating their methodology for their anaplasmosis marker because of a high margin of error.
I wish I could impress you by telling you I spent hours in a medical research library uncovering the methodological flaw with this. But in a lot of cases, these things can be elucidated by just applying some common sense.
Another thing regarding testing that is important to mention is that you should be looking for a test to provide you with information regarding treatment that you wouldn’t have without having the test.
So for example, if someone comes in with, let’s say, alterations of their microbiota ratios, if what you’re going to do—which a lot of the recommendations with some of these altered microbiota philotypes come back to taking pre-biotics, taking fiber or increasing fiber, and increasing dietary pre-biotic intake. You don’t need a test to tell you that.
You can simply try that and see how the person feels. Do their gastrointestinal symptoms improve? Do they sleep better? Do their neurological symptoms improve? Do they lose weight? Do other biomarkers improve, like their blood sugar or their cholesterol?
If you see a general improvement, you’re doing the right thing. If you see a general regression, you’re doing the wrong thing. You don’t need a test to tell you to do that.
So another component to this is, as you start performing this treatment—and I alluded to this a moment ago—you should be seeing an appreciable effect at least a majority of the time. And the majority of the time may mean 60% of the time. It doesn’t mean 100%.
But most of the time, you should be seeing an appreciable positive impact from the treatment which tells you that, “Okay, this treatment seems to be treating something that’s valid. And therefore, the patient is getting better.”
Always Criticize Yourself
And then something else that I think is incredibly important is—and this just sounds so simple. But I think it’s so profound. Always question if what you are doing is truly needed. Be trying to do less. Be trying to criticize yourself. Rather than always striving to do more, always be criticizing yourself.
And I think this is one of the most important reframings of how a practitioner practices, or if you’re a patient looking at the way your practitioner approaches these things.
If you can learn to be self-critical, what you end up doing is you cut out the fat, proverbially, from your care, because if you’re always criticizing yourself, you will start asking questions. “Is this working? Is this working? Is this needed? Is this effective?” And you’ll eventually start to figure out the things that aren’t, and you’ll stop doing those.
Now conversely, if you drank the Kool-Aid for whatever the functional medicine test or treatment du jour at the time is, then you’re just going to be so jazzed about whatever you’re doing, the probability that you’ll be able to pick out something that’s ineffective is extremely low because you’re actually placebo-ing yourself into seeing a positive effect where there is none.
So I understand wanting to be optimistic and positive in the way that you operate and frame things. I get that. But we also have to always be self-critical and not in a self-deprecating type of way but in a scientific way.
Science is very inquisitive and very humbling. And science will look at things and constantly be pursuing the things that actually work because they don’t have an emotional attachment. Science doesn’t have an emotional attachment to a certain philosophy or position or viewpoint.
And that’s why, I think, when you look at a scientist, most scientists tend to be objective. And that’s why I think people trust scientists because they are not going to put their preconceived beliefs ahead of what the information actually shows.
So that same thing is something that we want to bring into the clinic. If you’re someone who is a huge advocate of low carb, you shouldn’t be looking at everything through a low carb lens because it’s not going to work for everyone. It’s not going to be good for everyone. So those are some of the more key thoughts that come to mind with this. Again, we’ll put some of the links in here if you wanted to look into more of the details.
If you remember back when Nick Hedberg was on a while ago and when Dr. Dan Kalish was on a while ago—and in fact, I think Dr. Kalish made the strongest criticism of urinary neurotransmitter testing. I think he said something along the lines of, “It’s unfortunate and sad that this kind of testing is still done because of a very low level of reliability and validity.”
So these things have been out there. But I think what trips people up is you’re a patient, or you’re a doctor, and you either have symptoms like fatigue, depression, brain fog, anxiety, or your patient has those symptoms and you have them pee in a cup.
And a test comes back. And it shows serotonin low, dopamine low. And here, give 5-HTP and give tyrosine and maybe mucuna. And this can help. And this will cure the problem or improve the symptoms or what have you.
It’s a very hopeful dialogue. I understand that. But we also have to be a little bit careful, because if we’re not looking at these things judiciously, then we can get wrapped into this runaway model of functional medicine that requires a copious amount of testing and a copious amount of treatment.
So just because something on a test looked hopeful, like, “Ooh, this is low. And I’m having this symptom. And if I just do this treatment, I’ll get better.” That’s not always the case.
And unfortunately, sometimes that desire of a practitioner to help their patient or a patient to feel better is exploited to recommend some of this testing or to sell a test or to sell a supplement.
So I just hope that we understand that just because you want to help someone doesn’t mean you have to do more to help them. We want to do better and maybe a little bit less.
Episode Wrap Up
So those are some of the main things that come to mind there. Something else I just want to mention—and this is referring to The Future of Functional Medicine Review.
In the February edition of that I walk through a case study looking at a patient with Hashimoto’s autoimmune hypothyroidism and H. pylori and Epstein-Barr virus. And both of these have been correlated with Hashimoto’s thyroid autoimmunity. There’s some preliminary data showing treatment of H. pylori can dampen thyroid autoimmunity.
And so over the course of several months, we came to figure out what we should have done with this patient and what did not need to be done with this patient.
And I think this is a very helpful case study because it illustrates kind of what I’m talking about, where if we weren’t a little bit more conservative and discerning with our interpretation of lab values, we would have subjected this patient to months, maybe even years, and certainly several rounds of repeat treatment that was not needed.
So you can plug into that and learn more about that at DrRuscio.com/review. But that’s just something else, especially for the practitioners listening to this, that can be very helpful to that endpoint.
So in summary here, a neurotransmitter lab that was affiliated with a conjoined supplement company pled guilty to essentially falsifying lab ranges and what seems to be with a reason to be able to recommend certain dietary supplements to treat those lab ranges.
So unfortunate, but hopefully, these things were not done with mal-intent by the lab. But also, hopefully, this will be something that will help both patients and practitioners to be a little bit more discerning and conservative before recommending a certain test or treatment or what have you.
So we’ll put the links in there if you guys want to learn more about that. And hopefully, this 398-mg-powered conversation was somewhat coherent and you guys got a lot out of it. And that’s it. We’ll talk to you guys next time. Okay. Thanks! Bye.
If you need help with functional medicine, click here.
What do you think? I would like to hear your thoughts or experience with this.
Dr. Ruscio is your leading functional and integrative doctor specializing in gut related disorders such as SIBO, leaky gut, Celiac, IBS and in thyroid disorders such as hypothyroid and hyperthyroid. For more information on how to become a patient, please contact our office. Serving the San Francisco bay area and distance patients via phone and Skype.