Dubious Press Release from Cedars-Sinai linking Irritable Bowel Syndrome (IBS) and Bacteria in Gut

Quick one here.

Not impressed with this press release from Cedar-Sinai: Dr. Pimentel links IBS and gut bacteria – Cedars-Sinai (see other variants of it here: Daily Disruption – Cedars-Sinai Study Links Irritable Bowel Syndrome (IBS) and Bacteria in Gut and here: Irritable bowel syndrome clearly linked to gut bacteria).

Among the things that bug me here:

  • They don’t include a link to the paper or even provide a citation
  • They claim that culturing microbes is the “gold standard” for connecting bacteria to the cause of this disease.  AND they imply this is the first method to use culturing to study the disease.  Both notions are wrongheaded.  
  • They confuse cause of IBS and symptoms.  They say that b/c antibiotics help reduce symptoms, therefore, bacteria cause the disease.  Really?  So then fevers must cause things like malaria and flu because ibuprofen helps reduce symptoms right?
  • At some point it might be nice to mention that the MD behind the new study has also been pushing the idea that IBS is caused by bacterial overgrowth for many years both in a book and via a testing company though it is unclear what his association with the company is.  I note – ads for the book claim ” In addition, Dr. Pimentel presents a simple treatment protocol that will not only help you resolve your IBS symptoms, but will also prevent their recurrence.”  So – apparently he already had a cure BEFORE the new study was even done.  I general I am skeptical of papers that show evidence for something coming from someone who apparently already “knew” the answer.

Of course, I am not saying IBS is NOT caused by bacterial overgrowth as they claim.  But I can say this – PRs like this make me skeptical that anything new was done in this current publication.

Overselling the microbiome award: Scientists look to mummies for obesity cure

Seriously?  Scientists look to mummies for obesity cure.  I mean – yes – I do think it is possible that antibiotic use has screwed up the human microbiome across the planet and that might have led to other problems.  But for 3$&#$# sake there are 1,000,000 plus other things that have changed since the time of the mummies from diet, to pollution, to longevity, to urbanization, to sedentariness, to TV, to … well … almost everything.  So – sure – the microbiome in “the ancients” might be different (I don’t see a paper here).  But the headlong “look for mummies for obesity cure” is pretty darn misleading.  And thus I am giving MSN one of my coveted “Overselling the microbiome” awards.

Diabetes & H.pylori – a correlation but no known causation despite authors claims

Am having a hard time right now with the comments from the authors of this new paper showing a correlation between H. pylori presence and both type II diabetes and blood glucose levels.  As far as I can tell, the paper does not show any causal connection.  That is, they do not determine if H. pylori infection is a cause of blood sugar issues or a consequence of blood sugar issues.

Yet the authors of the paper, one of whom (Martin Blaser) is a very respected H. pylori expert are saying things like

This study provides further evidence of late-in-life cost to having H. pylori,

And they suggest that antibiotic treatment for the elderly may help prevent diabetes.

This to be seems to be a bit over the top.  Yes, it makes sense that H. pylori could cause these issues.  And they have a model for how it might.  But they really should be more careful with their words until a causal connection is established.  After all, we have many well known negative effects of antibiotic overuse, including some shown by Blaser.  The last thing we need is people going out and dosing up on antibiotics in the hope that it will prevent type II diabetes.  But I can guarantee that is what will happen if this story gets overplayed.

At least a few sources report on the lack of anything showing a causal connection (e.g. see US News and World Report):

An expert not involved with the study said that while it did not show a cause-and-effect relationship between the bacterium and diabetes, the findings suggest certain possibilities

But I am worried that that is not enough skepticism to counteract the claims of the authors here. The study is certainly interesting.  And their model for a causal connection is fine.  But they probably need to do a little bit of toning down of their claims here.

UPDATE: 3/17/13

After some people asked me questions about this study at a few recent meetings I dug a little deeper.  And I am a bit startled to find out what the basis is for Chen and Blaser to claim a causative association between H. pylori and type II diabetes/ glucose levels.  Here is a summary of their logic:

Helicobacter pylori is acquired almost exclusively in childhood [8], and there is no clear mechanism for how glucose intolerance present only after the age of 18 would increase risk of H. pylori colonization. It also is unlikely that H. pylori positivity and high levels of HbA1c levels share a mutual antecedent cause because there is no diathesis to both acquire H. pylori and to cause glucose intolerance.

They go on to discuss other lines of indirect evidence for why they think their conclusion is correct.  And some of this is very suggestive.  But “likely” and “suggestive” is not proof.  There are many possible issues with their conclusion.  In particular I think it is easy to come up with a scenario whereby something about the host (either their genetics or their history of exposure or even their micro biome) could influence both whether or not they get colonized by H. pylori or even whether or not they get colonized by particular strains of HP.  And the same factor could influence microbiome interactions later in life.  I see no evidence to indicate that H. pylori is the causative agent here.  And for them to then basically recommend prophylactic antibiotics for elderly with HP seems dangerous at best.

Probiotics are the new viagra & the risks of overselling of probiotics

For crap’s sake.  Really.  This is for crap’s sake.  I have been sniffing around the web looking into stories about probiotics and, well, it is scary.  So much of the stuff out there is so incredibly awful.  There are so many sites out there offering probiotics for sale it reminds me of viagra.  But in a way this is way worse, because at least viagra sales only really offer to cure one kind of ailment.  Probiotics offer to cure everything under the sun.  And more.  And along with these offer’s to cure everything come some seriously worrying practices.

Take for example this press release: New Website Offers Analysis On Top Probiotic Supplements.  This new website is “BestProbioticReviews.Com” and it portrays itself as some sort of neutral party.

BestProbioticReviews.com is a comprehensive yet easy-to-read guide offering product reviews on the top 3 probiotic supplements on the market today. Learn more about the best probiotic supplements and their review today.

They go on to report that

Based on the tests performed, the best probiotic supplement that has achieved the highest possible rating is Nutraelle DigestiveCare. The probiotic supplement received high marks because it was said to help consumers improve their overall digestive health, immune defense, and little to no side effects.

And follow this with

Of course, BestProbioticReviews.com wasn’t set out to provide just product information. We’ve included a special section outside of digestive health and showed our readers’ probiotics help in many ways other than just inside the gut. We discuss how probiotics in general can help (http://www.bestprobioticreviews.com/probiotics-IBS.html) probiotics IBS relief, bacterial vaginosis, yeast infections, and respiratory health problems like asthma.

So – they first imply they are neutral.  Then they tell you about the small benefits of probiotics and then go on to discuss how probiotics can help with lots of other ailments.  And then they link out to sites for buying the three different kinds of probiotics they recommend.  The #1 recommended priobiotic is something called Nutraelle which apparently has all sorts of benefits, though the * tells us none are supported by the FDA.

Anyone want to bet that this web site is actually somehow affiliated with one or all of the places it recommends?  Interestingly, if you look at who is running this site it says it is:

Kelly Moore
Best Probiotic Reviews.com
815 1st Avenue
Seattle, Washington 98104
(206) 624-3313

A little snooping around finds a press release from the same phone number for Alpranax – a claimed anti anxiety med.  The web site for this med has some striking similarities to the one for the probiotic promoted by Kelly Moore.

And alas, looking around the web for people selling probiotics, it really is starting to resemble those selling erectile disfunction treatments or various other therapies. Now mind you, I am not saying here that probiotics do not have potential.  They have been shown, here and there, to have positive benefits for a variety of ailments.  But I am going to repeat something here I have been posting every once in a while:

For the statement “X manipulations of microbes help treat X ailments in X people X of the time”: X=”some” NOT “all”

Or, in other words, the few studies that have been done on probiotics have shown that they can be effective in some people some of the time to treat some ailments.  But extending this concept to all probiotics help treat all people all of the time for (all or many) ailments is ridiculous. And alas, that is what some supporters of probiotics are doing.

For fun, here are some links discussing some issues with claims about probiotics

Here is some interesting reading relating to the potential for government regulation of claims about probiotics:

I hate to see more regulation by the government without justification.  But I am starting to wonder here if some more stringent regulation may be needed here.

Personally, I think probiotics have a lot of potential.  And more and more scientific studies are telling us where that potential is, and where it is not. But this risks getting lost in the midst of overselling, scams, and deceptive practices.  Here’s hoping evidence becomes more a part of the culture (pun intended) here.  

Clarification to Overselling Microbiome Award to Marshall Protocol: Critique of some claims by supporters, not protocol per se

OK time for a bit of a clarification.

Recently I gave out a somewhat aggressive “Overselling the microbiome award” to supporters of what is called the Marshall Protocol. I have started this award because I feel that many working on microbiomes have been overselling the potential for these studies to lead to cures and treatments for all sorts of ailments. And certainly,, some associated without the Marshall Protocol are making what I consider to be extremely overstated claims about this particular treatment.

But after talking to a supporter of the protocol here at the microbiome meeting I should clarify here that I was not actually critiquing the protocol itself. I was criticizing some of the claims of supporters of the protocol. In a way I erred in the same way that critiques of genomics have erred – where some have said genome sequencing is not useful because some promoters of genome sequencing oversell it. So I should have been more careful .. I should have focused on the claims about the protocol by some supporters. I stand by my criticism of some of these claims. The protocol seems to have no, or very littke, evidence that it works. And thus I did not like the claims that it cured all sorts of ailments.

But overselling the protocol by some supporters does not mean that the protocol does not work (though, again, I see no evidence that it does work). And overselling by some also does not mean that all supporters oversell it. It seems clearly that some of the supporters are sincerely interested in testing whether it works. In fact the person I talked to said they will work very hard to make sure that claims without evidence are removed from the Knowledge Base web site associated with the group supporting the protocol. I hope that is true. I am still skeptical about the activities of some supporters of the Marshall Protocol and whether the protocol can work. But at least some of the supporters really want to do clinical trials and use science to test the Protocol.

Overselling the microbiome award #2: The Marshall Protocol

Wow – until I started sniffing around actively, I never realized how much crap was out there in regard to the microbiome.  But there is so so much.  Certainly, the human microbiome (the microbes that live in and on people) is more important than people used to think.  The microbes in and on us show some interesting correlations relative to disease and health states.  And almost certainly changes in the microbiome likely cause some alterations in health state.  Recent studies on fecal transplants, for example, suggest even that altering the microbiome is both possible and could be helpful in some cases.  But we are really early in the work here.

But right now, for many health and disease states
(1) we don’t know if the altered microbiome is a cause or an effect or not related at all and
(2) even if there were a causal relationship between microbes and various health/disease states, there will also be enormous complexities relating to history and genes that will be very hard to sort out
(3) even if we knew a causal relationship this would not mean we would know how to change the trajectory (e.g., what microbes are there) in a useful way

Because there is so much iffy stuff out there relating to the microbiome and because some are starting to use studies of the microbiome to indirectly lend credence to their crap, I have decided to start giving out an “Overselling the microbiome award”. I gave out the first one a few days ago: Overselling the microbiome award: Stephen Barrie on pre and probiotics at the Huffington Post

Interesting, Barrie posted a comment on the blog trying to defend his post, but I was not convinced.  I think he did not understand my point about correlation vs. causation but am not sure.

Anyway, after I wrote the response to Barrie I looked around the web for others using the term microbiome in what seemed to be unsavory ways.  And I found a really painful one.  This is something called the “Marshall Protocol Knowledge Base.”  This so called knowledge base is a web site set up to promote, you guessed it, the Marshall Protocol.  The Marshall Protocol is “a curative medical treatment for chronic inflammatory disease.”  In turn this protocol is based on the Marshall Pathogenesis which is “A description for how chronic inflammatory diseases originate and develop.”  It follows that this Marshall Pathogenesis “posits that chronic diseases (termed Th1 illnesses), are the result of infection by an intraphagocytic, metagenomic microbiota of chronic bacterial forms that are often referred to as the Th1 pathogens.”  I have read the last sentence dozens of times and I still do not know what it means.  What is a metagenomic microbiota?  I just do not know.

Anyway, I am sure everyone will be shocked to find out that the Marshall Protocol Knowledge Base, the Marshall Protocol and the Marshall Parthogenesis are being promoted by someone named, well, Marshall (Trevor Marshall) who seems to be the head of the Autoimmunity Research Foundation which is the place promoting the Marshall Ps (I swear, I will not call it the Marshall Plan, I will not, I will not).

Based upon what appears to be little if any actual published research, the Marshall Protocol promotes the treatment of all sorts of ailments with in essence long term
high dose
cocktail of multiple antibiotics at apparently low dosage and a long term attempt to alter Vitamin D levels by treating in part with very high doses of a drug called olmesartan.  Among the ailments that this protocol is claimed to help are Crohn’s, Type I diabetes, Multiple Sclerosis, Psoriasis, Rheumatoid Arthritis, Celiac Disease, and many many more.  (I note they say “The Phase II clinical trial conducted from 2002-2008 by the Autoimmunity Research Foundation has demonstrated applicability of this antibacterial therapy to a wide range of chronic Th1 immune illnesses ” and then cite a powerpoint presentation).

I could go on and on.  But it seems clear to me that they are both making mistaken claims about what we know about the effect of microbes on health as well as making almost absurd claims about how one treatment system can cure a series of diseases by fixing ones microbial content.  Note I am NOT saying microbes have no connection to these ailments – studies are supporting the microbial diversity in people with these ailments is different than in people w/o the ailments.  Nor am I saying that Vitamin D is unimportant.  In fact, it is becoming clear that Vitamin D is much MORE important than people realized.  But importance alas, is different that saying we know exactly WTF is going on.  And certainly the treatment outlined by the MP folks here is not as far as I can tell supported by any evidence of effectiveness not is it obvious how it connects to scientific knowledge about microbes and vitamin D.

Fortunately, others have taken on the MP folks here and have written about how it appears to be a scam of sorts, and a potentially dangerous one at that.  See for example:

I know, there are lots of medical scams out there.  But this is the first one I have seen discussing metagenomics and the microbiome. And for that, I am giving the Marshall Protocol and the folks behind it, my second “Overselling the microbiome award“.

UPDATE 7/18/2012 – some stories worth looking at

Overselling the microbiome award: Stephen Barrie on pre and probiotics at the Huffington Post

Yes, I think the microbes that live in and on people are important, interesting, cool, and worthy of lots and lots of attention. However, I am getting sicker and sicker of the ways in which the effects of these microbes are, well oversold. So today I am starting a new series here on the Tree of Life – the “Overselling the Microbiome and Probiotics Award.”

And, we have a winner today. The winner is Stephen Barrie who has posted something at the paragon of high quality science – the Huffington Post (for more on the dubious science at Huffington Post, a good place to look is Bora’s Blog Around the Clock). Well, Barrie really takes the cake on this one

Stephen Barrie, ND: The Keys to Maintaining a Healthy Gut

He starts off OK – referring to the number of microbes in the human ecosystem and even quoting Jeroen Raes, who does some great work.

Then he mentions how

“These bacteria have a profound influence on human physiology, your immune system, your nutrition, and are crucial for human life.”

OK I can go with this — maybe an exaggeration but still within reasonable confines. Then the woppers begin

“The health of your body and mind is largely tied to the health of your gut”.

Wow- that is one serious jump – from these microbes have a profound influence to the gut driving health of body and MIND.

Then he goes back to some OK territory again, discussing some functions known for gut microbes, like vitamin production, preventing infection, etc. But just after this he switches to the woppers again claiming that out of balance microbes can cause allergies, inflammatory bowel disease, eczema, arthritis, irritable bowel disease, obesity, autism and personality changes including paranoia, hostility, aggression and so on. Completely ludicrous actually. What we know about these issues is that researchers have found that microbial populations may be altered in people with these maladies. But that does not mean the alteration in the microbes caused these maladies. It could be that other factors cause both the malady and the microbial alteration or the malady itself could lead to altered microbial populations.

But wait, it gets a bit better. Now that he has established that microbes cause all these problems, he tells us how to

“avoid one of the emerging causes of both obesity and food allergies? Lower your risk of inflammatory bowel disease, irritable bowel disease, eczema, colon cancer (15) strengthen your immune system? All this while reducing any levels of paranoia or hostility (and retaining your Jon Stewart sense of humor).”

The recipe for prevention is as follows:

  • Eat a low fat diet rich in vegetables, fruits and complex carbohydrates
  • Limit consumption of animal protein
  • Reduce sugar consumption
  • Increase pre-biotic and probiotic intake
  • Consume enough soluble and insoluble fiber to maintain a daily bowel movement. A slow bowel transit time leads to increased exposure of your body to toxic bowel contents.
  • Reduce dietary sulfate consumption.

Again, I am all for more research into the microbiome.  And I think microbes that live with us must have all sorts of positive and negative effects on our health.  And yes, I understand why “probiotics” and “prebiotics” are getting lots of hype.  But because Barrie has gone from what must be a gut feeling (sorry) to making medical claims without evidence and prescribing treatments to cure ailments that probably don’t exist, he is the recipient of my first “Overselling the microbiome award”.