Dietary Supplement Practicum 2018: Meeting the Stakeholders–Meet the Watchdogs

>> Paul Coates: So, now we're going to meet three people who do something a little different in this space, and I'm not going to introduce them with all of their credentials Rather, I'm going to ask each of them to do what our industry colleagues did: what do you do in this space? So, the first of our speakers in this segment will be Laura MacCleery who's from the Center for Science in the Public Interest

What do you do Laura? [applause] >> Laura MacCleery: Well, hi there I am Laura MacCleery, and I'm a lawyer I've been doing public interest advocacy work mostly in the public health and good government spaces for 18 years And Center for Science in the Public Interest is an independent, by which we mean we take no government donations or industry money, nonprofit organization And actually, dietary supplements are, I would say, a very small part of our overall docket So, you know, here's a snapshot of some things that we do

Really, we are an Innovation Lab to push for public health transformations that drive change So — you are — one of our achievements is coming to a restaurant near you or has, as of several weeks ago calorie counts on menus That was really an effort that was led by us The ban of trans fat from the food supply and first its labeling was an effort that CSPI helped lead We led the fight for healthier school meals for school children

And we use a mix of tactics and methods to achieve the changes that we seek Everything from regulatory involvement to litigation in the courts on class-action claims around false and misleading products to legislation and, of course, public education A centerpiece of our work and our independence both is our Nutrition Action Health Newsletter This is a 10-times-a-year publication It's very affordable

I commend it to all of you It's a terrific magazine that really reviews with rigor the science behind a lot of claims that float around in the food, health, and nutrition space And over the years we've done a lot to debunk and analyze the effectiveness of various types of dietary supplements So, this is the work that I draw in as the regulatory lawyer thinking about what things we should bring to the public's attention and which things we should bring to the Food and Drug Administration's attention about supplements One of these Diabetes Defenses, I'll talk about this a little bit later, but it's, you know, in the area of unapproved drugs we have particular concerns

So, if there is a claim being made that a supplement, you know, counters the symptoms of diabetes or prevents some aspect of diabetes we are going to take a particular look at that Most of the studies you'll see in this — you can't read it up here You have the slides in the booklet — were actually underpowered to the outcome or found no effect And you do see these kinds of stories populating the web In particular, cinnamon has magical properties

I think a lot of this is that there's a lot of magical thinking around food in general and dietary supplements in particular We also tend to look at particular claims So, the example in the other article on Prevagen, for example, the company touted the study but failed to disclose that the placebo was equally effective You know, this is not unusual There's often a slim or no evidence behind many of the claims, and it's tricky from a regulatory perspective because the Office of Dietary Supplement Programs does attribute claims that are around an article a product that's being sold as a supplement as imputed marketing

But oftentimes what you have on the shelves are, given that companies have gotten very savvy, is you'll just have the bottle say, St John's wort or cinnamon capsules or something And there's no claim at all So, therefore the consumer is then vulnerable to reading about on the web some separate marketing material that's off the label that may tout the benefits of a particular substance, and yet it's very hard for FDA to make the enforcement case against the company This is another example of two Nutrition Action Health newsletter articles that we published on on testosterone

It's a three-page article If you subscribe you'll get access to the full thing, but the upshot was that while low testosterone is a legitimate medical condition of course that needs treatment in some cases that it's being oversold and that actually taking excess testosterone raises some risk of cancer It's not totally clear On the probiotics, you know, the recommendation that came out of that was that they're oversold They don't need to be taken daily

They can help with particular conditions, and there's usually strains that have been identified as helping with particular things like while you're taking an antibiotic or if you have some kind of other infection So, you can take those particular things, but that a lot of probiotics offer scant or little benefit maybe one day less of a cold for example I got involved personally in dietary supplements with a very dramatic case I read in the news — dietary supplements had been part of my docket but in addition to sort of Nutrition Action, doing these publications, and the 2013 Durbin bill that we had been involved in,as well as the industry and trying to push for register product registration This issue came up in the news, and I read the headlines just like everybody else

And I became immediately very concerned that pure, powdered, or, in some cases, highly concentrated liquid caffeine was being sold on the Internet It was sold at 999 percent concentrations A tablespoon — in five-pound bulk bags or two-gallon jugs, and a tablespoon could kill an adult A teaspoon could kill a child

The proper dose was a 1/32 of a teaspoon which no one has the ability to measure at home So, we wrote a citizen petition and submitted it to the Food and Drug Administration These two young men are Logan Steiner and James Wade Sweat We worked with their families who came to Washington on their own dime on multiple occasions to meet with lawmakers and publicize about the issue We had press conferences on the hill

The FDA initially issued five warning letters to companies that we had identified as selling these products We did a spot check of the market within six to nine months later I forget exactly the timing, and there were still multiple availabilities of this product on the internet You could just get it So, we ordered the product

We took it up to the hill We had this kind of show-and-tell with reporters that we could still get these products even though the FDA had issued a warning letter There was also a third death that showed up in the medical literature where a person had taken — a man had taken the caffeine and thrown it up all over the dashboard of his car and had went into cardiac arrest which is how you die from a caffeine overdose And there may have been occult deaths that were showing up in the medical literature because if you take a high dose of caffeine and then are going to exercise or, you know, jog outside or something, and no one connects the substance with the heart attack If you had a normal autopsy for a heart attack you wouldn't be looking for caffeine levels in the blood

So, there could have been heart attack cases related to these products that just didn't show up because no one did a second autopsy specifically looking for caffeine levels Just recently in April 2018 we were so heartened to see that the Office of Dietary Supplement Programs actually put out in a final guidance that these products are illegal or adulterated per se because if they're sold in an amount that's lethal to the end consumer, if they're sold in bulk, that even a scoop like a little scoop that came with the bag, which is how they had been continued to be sold, they said could be separated from the bag and would pose a danger And that's true Logan Steiner s friend gave him some of the powdered caffeine in a little baggie separated from its original packaging So, once these things are in circulation it's very hard

And I think the trend is very concerning because what it shows is that there's a lot of bulk supplements that are kind of inputs to formulated supplements by the major brands and companies And those you can purchase directly from China or through bulk supplements websites here in the US And basically you're dealing with raw ingredients in their uncut form So, you know, this is the FDA kind of pushing back on the ability to turn around and then make a profit by selling that

We also, in December, put out — as I said we're very concerned about unapproved drugs Things that are marketed essentially to treat disease as dietary supplements And FDA has a guidance that says that they're going to prioritize enforcement of unapproved drugs because they pose as legitimate treatment for a medical condition In the case of opiate addiction there are medically approved treatment protocols that are known to be effective for that condition Few people have access to them

Some may not even know about them So, the temptation to then go to use a dietary supplement or not to have to go to a doctor that might be affiliated with your employment and admit to an addiction problem is very high So, into that gap have rushed a number of, as Duffy would say, bad actors These are companies that were marketing opioid withdrawal aids in the dietary supplement marketplace Some of which were sold on Amazon or Ebay and other places

We wrote to the companies, and when I say we I mean the grander we David Schardt , my colleague, wrote them letters as CSPI, you know: Do you have scientific studies showing that any of the ingredients in these products are effective for opiate addiction relief? These are the responses we got back: Scientific studies are very costly So, no, we didn't bother We don't really have any scientific studies as such currently These are, you know, very common for the bad actors within the industry

I would agree with the characterization that there are better and worse companies in this space The problem is that the worst companies create an atmosphere of consumer confusion and fraud, sometimes outright fraud In January FDA and the Federal Trade Commission, which we had also written to about the illegal marketing of these products and which has already brought several cases on the opioid dietary supplement claims, took action We were pleased to see that they went out into the marketplace and found additional bad actors that we hadn't uncovered in our initial research, and they issued a number of warning letters to those companies So, that is the first step in an enforcement action

I assume that the agencies will follow up and see whether in fact the companies have ceased selling those products In some cases, the Department of Justice or FTC may go after the companies and seek aggressive, kind of, consumer penalties and even repayment of consumers who were defrauded Obviously, with a condition like opiate addiction it's life-threatening With other products what we see is that there's just widespread economically motivated adulteration which is lawyer speak for fraud In the case of ginkgo we noticed that there was industry monograph pointing to widespread adulteration of ginkgo products which is one of the top sellers among dietary supplements

And that there was strong incentives to substitute other parts of the ginkgo tree or buckwheat for the allegedly active parts of ginkgo It's not a great supplement to begin with because there really isn't good evidence that it's effective for many of the things that patients may take it for like memory loss or muscle and joint benefits So, we wrote FDA and enforcement letter saying these are adulterated It's kind of like that joke, you know, the food's terrible and there's not enough of it Right? These are adulterated and they're kind of ineffective

So, some of those things led us to a recommendation to consumers to avoid ginkgo balboa supplements Our priorities when we think about advocacy are, first, that we need to protect the public from acute risks like pure caffeine We've also worked on the tainted supplements that are, you know, tainted with often performance -enhancing amphetamines or that sort of thing for weight loss Or from drug interactions we have a long-standing citizen petition to have a warning label on St John's Wort

We're going to ask for the same thing on beta-carotene because these have known drug interactions We also are concerned about unapproved drugs And then as a secondary concern we work on things that are about efficacy where we think consumers are being misled by an avalanche of claims These are a number of really in the weeds kinds of reforms, but basically they'll add up to we think there should be some kind of mandated third party pre-market oversight of safety and efficacy We recognize this as a fight that we lost in 1994

We think it's worth having another conversation with the industry about whether consumers and the industry really benefit from the current Wild West regulatory environment We also would back a registration system We think FDA needs more resources such as user fees, and that in a number of areas FDA should enhance its regulatory oversight as such as for new dietary ingredients That's the new Dietary Ingredients Guidance In addition, we think there should be a requirement for a substantiation of claims that things are effective for the purposes claimed

And that would sort of get out of the conundrum that Duffy had laid out which is how do you claim that something doesn't make you sick? And that there should be ongoing prosecution where things actually pose a hazard Thanks so much [applause] >> Paul Coates: Well, thanks very much Laura Tod Cooperman is from ConsumerLabcom and has been a regular on our program for quite a number of years

The only thing I need to watch out with Todd is that he always has so much he wants to say So, I won't take any of your time as long as you promise not to take any more time than anybody >> Tod Cooperman: I ll try Thank you, it's always a pleasure to be here, and thank you Pauls and Luisa for having me and ODS I will try to get quickly to really where I want to go is to talk about some of the interesting things that we have been finding at ConsumerLab

For those of you who are not aware ConsumerLab has been around for 19 years I'm a founder of the company We are basically people out there testing to see what's really in supplements and other health and nutrition products, and it's nice to see how the baton gets passed sometimes to the people of CSPI We actually found some of those problems with the ginkgo which were cited into the policy work that that CSPI is doing from time to time Again, I'm going to try to skip through some of the earliest stuff

Since 1999 we've tested over 6,000 products We put out a report every three weeks on another category of supplements We have about five or six categories always in testing, and that represents about 850 different brands that we've tested from And we're supported primarily by 77,000-plus individual subscribers plus libraries and other institutions that subscribe to ConsumerLab It's $42 dollars a year

And also if anyone's not a subscriber I'm happy to give you a free access for 3 months We're going to pass around a sign-up sheet which is what I do every year, and we're happy to extend that to you We're in the news a lot just because our findings are quite interesting to a lot of people Again, I'm the founder I'm an M

D Our head of research is Mark Anderson who spoke here the last year Twenty-two years experience in the dietary supplement area himself and an active member of the AOAC involved in developing protocols for testing supplements So, you know, why can't we just rely on the FDA and Good Manufacturing Practices with supplements? Well, as you've been hearing for the last two days you can't because, one, the FDA doesn't approve supplements nor does it register supplements Companies have to register but not the products themselves

Even though there are some listings of products they're not registered Good Manufacturing Practices, if you actually look at them, they can help, but they really don't include a lot of meat — a lot of teeth to them They don't include contamination limits They don't include ingredient identity parameters They don't include testing methods, and as, you know, as you've heard you can use a very simple method and find that a product has a hundred percent of what it claims or you can use the right, you know, rigorous method and find that it has very little or none

So, manufacturers are the ones who get to determine these issues, you know, these parameters They are supposed to, you know, follow, you know, use good science behind them, but it is up to them So, you are trusting the manufacturer In 2016, 62 percent of the audits that were done of manufacturing facilities failed to pass all the criteria Typically, for the reason that they were not specifying or verifying the identity of ingredients

And you can actually link to our — there's a link there on our site You can actually see which companies pass or fail that audit We put we post that every year We'll be doing that in about a month again for 2017 So, what do we do? We do a lot of testing

We put out product reviews on nearly every category of supplements out there About 10 to 40 products are included in each of those We also have the oldest quality certification program You may know that USP has one NSF has one

We actually have the oldest, and it's actually the only one to publicly freely publish our testing methods and criteria for passing We do some specialty testing for academic researchers from time to time Really just to kind of help out, but really our big push is really to inform the consumer and the healthcare provider as to really what's inside the bottle in these products We also spend a lot of time looking at the clinical literature because you can't just look, you know, just at the product as we mentioned before, you know Ginkgo we want to test the product

We also want to tell our readers really what's the evidence for/against? What are the side effects? What are the drug interactions? You know, as Bill was mentioning earlier We also answer a lot of questions from consumers We have over 500 questions answered on our website It would be hard to miss us if you have a question about supplements and we don't pop up on Google We have an Encyclopedia of Natural Products on the site giving more clinical information

And also I realize I forgot to have on here, but we also have our listing of recalls and warnings that come out every week And that's an archive that goes back over a dozen years And a newsletter that goes out to about a 190,000 people now twice a week with the latest updates These are just some examples of the categories that we cover Interestingly, this year we actually include tested CBD supplements

Even though they are technically illegal they are being widely sold We want to know what's in them Apple cider vinegar, I'll talk about that So, it's not just a, you know, the traditional, you know, fish oils and — and minerals and vitamins We're looking at all kinds of things

We're going to be testing a canned tuna fish and canned salmon shortly just because the evidence for fish oil itself has waned, but the evidence for eating fish, you know, just gets stronger So, we want to find products that actually have the omega-3s and are enter free of mercury etcetera So, why do people care? Our members say, you know, I need to understand which supplements are best quality Physicians and dietitians tell us I use your reports protect my patients And even the industry those who actually have come to get products tested through us

And by the way it doesn't protect them from us not being able to test their products, you know, on our own, but it gives us an opportunity to increase the number of products because our real goal is to find good products for people, you know, who are looking to use them well So, what does the industry say? This is a VP of Marketing at a supplement distributor, you know, we're — we're an independent organization that consumers trust to help them choose quality vitamins and supplements So, what have we found? Well, one out of every five supplements that we've tested has been found to have been of poor quality That's a little bit better than it was before It had been one out of four

It's nudging toward one out of five Herbals have the highest failure rate, 39 percent, vitamins and minerals 20 percent, multivitamins higher than that though because they're complex, other supplements 18 percent, and then other nutritionals is about 25 percent So, overall it's about 20 — let's see 22 percent of the products we've selected if they have failed testing That's actually closer to, yeah, one out of five So, what do we find? We find too little or no ingredient in some products

Too much ingredient and I'll show you an example of that where you're exceeding up or tolerable intake levels for certain nutrients Inadequate labeling to describe ingredients, poor quality ingredients, spoilage of oils, contaminations with heavy metals, inadequate disintegration of pills, and unapproved label claims These are the kinds of things we're testing for We actually do just a little bit of testing in-house for disintegration make sure that pills break apart properly, but we have to do so many types of tests that we found it's better to use experts in different areas of testing So, if we get like a fish oil it may go out to one lab for PCBs and other ones for omega-3s and other ones for heavy metals etcetera

So, we're coordinating a lot of testing as well as doing some testing We select the products that we test for our reviews We purchase multiple samples at retail Products can never be sent to us As I said pill disintegration testing is done inside

Others are done out at other laboratories We publish the results All the results for the products that we buy and test on our own are published on our site for our members As I mentioned it includes the latest clinical information, consumer tips, and we include in there any products that pass through our voluntary testing as well We publish, as I said, all our methods if you want to see how we tested and evaluated any product anyone is welcome to click that link, and it'll show you how we test everything

And I wanted to show you an example from our multivitamin report Again, for those of you who aren't familiar with what our reports look like and what we're providing here So, this is from last year We do this report every two years on multivitamins It's an extensive report

Summary, 46 percent of the multivitamins we test it failed The biggest problem was actually with gummy vitamins They are, as it was mentioned earlier, they are very difficult to make I think it's very hard to control the quality in these, and I'll show you some examples of the other kinds of problems that we're seeing with the gummies We, you know, we start off with these reports with a lot of background about the clinical studies

Actually, Dr Sesso is mentioned in the in his study with centrum as mentioned earlier What we test for What we found We then move on to talk about, you know — oh, here's an example of disintegration

You can see how this product even after 60 minutes — pills should break apart within 30 minutes Even at 60 minutes we gave it a, you know, more time it still didn't break apart completely There should be nothing here at this point just as an example We show our kind of top picks for different categories of supplements But I want to get down to kind of the heart of our reports which was really here

Which is what we show in terms of the results for each product In terms of whether they are approved or not based on how they fared in our testing It doesn't mean they work or not We have other information about really what you should look for in terms of whether something might work, but here we're just showing from a quality perspective whether it had what it claimed And I'm going to shoot down to — as I said it was actually — I mean like here's a gummy from Walgreens

It claimed 400 milligrams of folic acid it had 757 percent As some of, you know, folic acid converts to folate at a higher rate than just the folate itself So, that it's actually equal to about twelve hundred and eighty-seven dietary fully folate equivalence So, you're going from what claimed to be 400 — sorry I may have said milligrams, micrograms And we're finding 1,287

So, we're finding three times as much, you know, folate equivalence in this product The upper limit is 1000 So, you're actually potentially doing yourself harm, you know, by taking this multivitamin This is some more quick examples, and it's not every gummy where we find the problem that we — here's another one 174 percent We found the number to be to be off on their vitamin A levels

This is a tablet that was off on its folic acid And companies are allowed to, and they should put in a little more than, you know, than is necessary to make sure that it lasts through the expiration date But these are really, it's in our opinion, excessive Let s just go through And here's Vitafusion, I know we have a representative from that company

Again, way much more folic acid than claimed So, 1,382 dietary folate equivalents instead of, I believe, 400 Here's another one Bayer that one actually had what it claims So, you can make a good gummy, but I think it's very difficult I'm going to jump out of this go back to the presentation

So, some other interesting recent findings, as was mentioned, ginkgo biloba So, four out of the ten supplements that we purchased off the shelf were found to be — only four were approved I'm sorry six failed They were basically adulterated They were spiked with compounds from cheaper plants to make low quality ginkgo appear to be high quality

And the way that herbal companies do this, herbal suppliers, is they can take — take a real herb squeeze it out basically, you know, get a good extract from it, sell that, keep the junk that's left over — you know, it's kind of like making coffee and selling the grounds and calling it coffee They'll throw back in maybe one compound that they know a test is looking for They're spiking it with that compound, and then it'll pass whatever that test is that's looking for that single compound But if you're looking at the whole product, you know, the whole array of compounds it will fail testing, and that's what that's what's going on with ginkgo One product actually had no more than three percent of the expected ginkgo compounds

Apple cider vinegar, interestingly, all — good news is all these vinegar bottles these were all fine They all had about 5 percent acetic acid plus compounds that indicated they were made from real apple We also looked at these tablets that are being sold these because, you know, once something's out there there's going to be a pill So, we've looked at these, and what we found is that the amount of acetic acid which is probably what's really making these — these products help people lose weight in this sense They're potentially upsetting their stomach with the acetic acid

They don't have as much of an appetite And these pills have some acetic acid, but you really have no idea how much is in there We found as little as 04 percent acetic acid to over 20 percent Actually, based on just the amount of powder was about over 30 percent

It turns out that if you sell a consumer product, you know, like Drano that that that has over 20 percent acetic acid it's supposed to be labeled a poison This product, you know, was not The company responded saying that well, you know, it's not a consumer product It's a dietary supplement It's exempt from that law

My reading of the law is, actually, there's another place it says if you if, you know, there's a danger you have to label it In any event they did come back and agree to change the labeling to add that, you know, you shouldn't separate this product this capsule You should take it with a lot of water and take it with food So, it is nice to see that there is some improvement In all of our reports you will see at the top of every report it'll state, you know, the back and forth between these companies

So, if they approached us we will we will also offer to send it to another laboratory if they'd like to have it tested You know, almost every time it comes back finding what we found, and it's not that the companies were really trying to do something bad They often just didn't know what they were doing Last slide, goldenseal talked about earlier in terms of not actually being goldenseal You can see on the left this is real goldenseal it has kind of a slight golden hue to it

This is another one saying it's a golden seal root powder, definitely not Didn't have any berberine in it which is the key compound It's not yellow It's it would taste bitter which it didn't So, I could talk for a long time, but I'm going to stop

And again if you put your name on that list we will sign you up for a membership to ConsumerLab for three months Thank you [applause] >> Paul Coates: So, now I'm going to introduce James Hamblin, and we're going to do something just a little bit different with James's presentation I'm going to ask him to kind of introduce himself and what he what he does And then I'm going to interview him a little bit

We'll see how that goes, but James would you please start? >> James Hamblin: Yeah, so, I don't have formal remarks I'm here representing all of journalism, the entire profession But I want to represent that point of view which is a broad one I write for a general interest magazine that was founded in 1857 We covered the American idea

I came on to start the health section six years ago I left a radiology residency So, I am an MD and I constantly question that decision, but it's been great

And the reason I did it was so that I could meet people and tell stories and constantly learn about the world And be — the Atlantic's motto is that we are of no party or clique And that was really important to me that I not be tethered to any particular agenda or industry I still have the physicians code to do no harm I'm trying not to misinform people, but I'm not pro any particular — I m not pro regulation, anti-regulation, pro-big-government, pro-supplement, anti-supplement

I can take each story as it comes and try to shine a spotlight where we need to and to contextualize and to inform and to offer nuanced stories to our readers So, I'd like to be here to be part of the discussion to offer that perspective, and I'll talk to Paul now >> Paul Coates: Why don't you come on and sit down, and I'm going to maybe encourage you to particularize some of the things that you just said Why are — why did we ask you here to represent journalism? Which is essentially what you're doing >> James Hamblin: Yeah, I mean I think that there, you know, there's a lot of misinformation on the internet, and if you're a clinician, you know, a lot of people are coming to you having some idea of one thing that they read about one supplement

And they don't know if it's true And when you trace it back it can often come from a third party that is definitely not a disinterested party that is trying to sell the supplement or from even a physician who's selling both books that purport to inform people on a new diet plan and then also on their personal website selling supplements that are recommended in the book So, it's really important that journalism exists as an institution where you know that no one — if you're seeing this at on the Atlantic, on the New York Times, the Wall Street Journal, you're reading this from someone who is not also taking money from any of the interested parties and is doing their best to simply cut through it all And as I go through more and more nonsense on the internet you can at least go to these places and not trust everything that you read blindly but have a much higher threshold for thinking this is probably accurate This person is probably in good faith tried to give me the best information that they could

>> Paul Coates: What have you written about supplements that people — >> James Hamblin: I've written so much I get sort of — the couple interesting things to know are like — yeah it's — so, like I said I started the health section So, I was covering everything that had to do with health We moved very quickly Like when you're working with journalists if you want to be involved, be interviewed, you know, make contact information readily available make as much information available as you can

Make yourself accessible because people move real quickly, and they're often working way out of their depth I mean there's something good to have reading a story by a journalist about caffeine supplements when that journalist is coming into this fresh, and they don't really have a lot of background with caffeine supplements So, you know, they're going to come they're going to talk to people They're going to make sense of it This is a smart person who knows about science, and you're going to read their take away

There's something nice about that As opposed to getting a story from someone who's been covering the industry for 20 years, and it has lots of biases and kind of probably didn't have that But at the same time that means that that journalist who's coming in fresh needs — probably has a few hours to talk to as many people and learn as much about this as they can, you know, especially if it's a news story So, everything's not always going to be perfect, but the more that all of you can make yourselves available and be part of the conversation the better And then, to that end, I've written about pretty much almost every kind of supplement

Yeah, lots about caffeine, lots about vitamins, melatonin >> Paul Coates: So, tell me — you mentioned caffeine a couple of times — what were you trying to learn? What were you trying to convey to people about caffeine containing dietary supplements? >> James Hamblin: There have been a few different stories I have — I wrote a — there's a company that was selling topical caffeine sprays that interested people for a while So, it's kind of when there's a new product or something people are talking about I'll try to cut through how much of this is accurate? How much of it is not? And I don't know there have been, yeah, multiple different sort of takes on it I guess Caffeine is something that fascinates people because to so many people it's totally fine when you drink it in coffee

In fact, it's almost weird if you don't like drinking coffee And then it becomes very weird if you're spraying caffeine on your skin, and even weirder if you're spraying it at other people They just — and then just think about why that distinction should be and then why you should be thinking about one thing that is a supplement which — which is a stimulant which can have serious effects and we regulate that as not pharmaceutical >> Paul Coates: It's obviously come up a few times I think I don't know whether it was covered earlier, but I did come in during Patty Deuster s presentation

And you expressed concern about the levels of caffeine exposure that warriors and their families are likely to be engaged in So, it's — there have been regulatory efforts So, what was your take on it? Was it that you were concerned about the health of people? That they were not paying attention to the signals? Were — was there some other aspect of this that got your attention? >> James Hamblin: I think it's really easy in a meeting of people who think about this stuff as much as all of you do to forget about the average level of literacy around supplements, and I'm constantly confronted with that My readers write to me all the time and that does inform my work And a lot of people just have no idea that anything they're buying from the store could be potentially less than a hundred percent exactly what it's labeled to be

And that it won't definitely do exactly what the label implies that it will do And just constantly reminding people of that And then the duality of, you know, when people buy something when they need a prescription for it they tend to take that very seriously and follow the label to the T And when it's something you can buy as much of as you want there seems to be no reason to not take as much as you want So, just reminding people this is not necessarily pure

It's not necessarily good for you, and you can overdo it More is not necessarily better Those are probably three themes that people seem to want and need to be told again and again about different supplements >> Paul Coates: So, do you — you're kind of leading to something that I was going to ask you about You get reactions to your stories, and do you then — does that lead to a conversation with readers? >> James Hamblin: I wish it was more interactive

I mean we sort of use social media to try to make it not feel like you're just proclaiming things to people or decreeing So, we were talking about this earlier There's a lot of mistrust of journalists right now Like 12 percent of Americans trust the media, which is a term I don't like But the one group of people who have made it their job to just simply try to discern truth and convey it to people are very mistrusted right now

And part of that is this sort of elitism of just seeming like we know exactly how the world is and is supposed to be And I get that, so I try to be interactive with people and be open-minded and say what we know, and say what we don t know And not try to be talking down to people as the definitive source on exactly how much vitamin D they should be taking or — but at the same time not leaving it up to people to — not implying that we don't know anything >> Paul Coates: Do you feel you ve learned a lot from — >> James Hamblin: No, I mean I m in it because I because I want to just keep learning >> Paul Coates: What are the big messages for somebody like you? >> James Hamblin: Health of communicating around? >> Paul Coates: Sure — >> James Hamblin: Yeah

>> Paul Coates: Of course I'm interested in the supplement component — >> James Hamblin: Sure, sure It s — so, people I mean on so many — I think people are really, really drawn to supplements because they offer something that is — it helps them feel control Most health solutions are about control and making sense of something that doesn't make sense to you Especially when it's a serious diagnosis It's very rare that someone can be diagnosed with a cancer, and they could say, Oh, yeah, well, that makes sense that would happen to me

You know? And then you're just grasping for solutions and the medical establishment tends to be really rational about saying, Okay, we can give you this chemotherapeutic agent There's a 70 percent chance it will increase your lifespan by this many years, and you'll have these side effects And then you can also go to the store and have something or read something on some blog about something that seems just absolutely perfect Like almost no side effects, relatively cheap, and it cured this one person's kid So, they offer that sort of, even to rational people who are science-minded, to just say, Yeah, I mean why would I not at least try it

So, I don't know I guess I think a lot about the the appeal of that And then how to not rob people of that effect by debunking it because I think there's value in that, but then also accurately telling people you're probably wasting your money or possibly hurting yourself You re possibly miss-focusing your energy on something that is nonsense as opposed to emphasizing the things we do know that could be helping you >> Paul Coates: You actually — you used an interesting word there that I think we've used in our own thinking about how consumers approach dietary supplements

It's to take a little more active control of their own health Sometimes it's in the context of maintaining health, and that's a somewhat different circumstance from somebody who is seeking remediation of — you used a potentially, you know, very strong — a poor outlook for a disease state that's not going to get any better by itself My words to convey what you said But for the most part its consumers who are seeking health that are taking dietary supplements That's not everybody

We know there's no everybody in here But for those who were taking dietary supplements as part of a healthy pattern of health seeking behaviors do you see them as a different kind of audience from the ones that you just described? Where they are maybe actively seeking solutions to acute problems >> James Hamblin: Yeah, I think — and that's probably most people who are going and reading New York Times general interest magazines about the latest supplements And whether they should be taking a multivitamin And whether something is going to be, you know, helping them prevent a heart attack later on

You're not getting as many people who are reading about their specific condition And that's part of the interesting thing about a general interest magazine You want things that are going to be interesting to most people not just to people with polycystic kidney disease So, that's who we end up writing to most of the time And you could almost break it down further

Right? People who are just hoping to maintain the status quo And then people who are trying to improve themselves Like in the case of military uses those are all supplements that are actually making you better at performing or promising to make you better at performing And, yeah, it's a simple idea of maintaining status quo It's, again, very easy to sell people on the idea that it's harmless

It's — you're not spending a ton of money Worst case scenario you're flushing some vitamins down the toilet, and I also like to remind the psychology that we were always making trade-offs And that we're justifying things to ourselves And that when we do take a multivitamin it likely changes our calculus on how healthy we need to be in the rest of our lives And this is mostly — I don't have a study off the top of my head, but I have a lot of anecdotes of people who will think they can take the multivitamin and eat pizza

And if they didn't have that multivitamin then they might have ordered something healthier So, we're not exactly comparing the exact same life plus or minus a multivitamin It's how does that change the psychology of the user? >> Paul Coates: That's reasonable thing to say I'm looking at the clock only because I want — I have a feeling that you may have stimulated some thoughts in our — >> James Hamblin: Oh yeah, I'd love to talk about whatever anybody's curious about in journalism >> Paul Coates: So, what I'm going to do now is invite all three of the panelists from this session Laura MacCleery, Todd Cooperman, and you to hang out here and take some questions from people in the audience

And then we will end the day by having all six of you join us up front here and engage in further discussion So, thanks a lot James [applause] So, we have an opportunity to talk to these folks First, I see Duffy in the back with a question >> Douglas MacKay: You ever saw — from the media perspective I'm always curious

You know, we do our advertising review, and we try to self-police there And it's often shocking that reputable organizations will take terrible advertising that's just clearly with claims that are too good to be true, you know, promising things that could not be substantiated I'm just wondering do do any of these newspapers do you ever hear them having policies in place that says, you know, we should not just take these people's money we should vet the claims a little bit? >> James Hamblin: Yes, the critical thing about — you guys probably mostly know this, but the structure of any journalistic media organization is there s a thick firewall We do not even share any of the same space with people who have anything to do with advertising So, no journalist has any say in any of the ads that go into our magazine or onto our website

If we see something that seems particularly egregious we're welcome to file a complaint or send it over to — but it's a completely separate area of the business And it's it's meant to be that way And I know that they — within Atlantic media they have standards and don't want to be misinforming people with any ad content I don't know exactly how those calculations are made at other places We certainly wouldn't run an ad that seemed to be, you know, doing harm for the world

But I'm yeah — I guess the important takeaway is that I have nothing to do with that and no journalist does And a lot of people think that's or don't understand that that's the case >> Paul Coates: Other questions from the audience or perhaps do you have questions for one another on the panel? There's a lady in the back here All the way in the back, yes, and then the lady in front >> Female Speaker: Yeah, this question is also for James

What kind of sources do you use? Do you use responsible journalism like our PubMed and CINAL for some of your sources when you're doing a story, or do you — what kind of sources do you use? >> James Hamblin: Yeah, I'm — certainly not irresponsible sources Yeah, so, I just finished up my MPH actually So, now I feel really good at vetting methodology and statistics I have statisticians on call who I will try to vet studies for I'll try to, you know, I have higher thresholds for going for studies that are in bigger journals, but I've seen terrible stuff published in JAMA and the New England Journal

And you just try to — you know, I have a network of people who I'll send it to and be like, Do you have any time to look at the methodology on this? Because probably I'm going to write something in a day, and the people who can give me a comment are not always going to be available or always going to feel like they can really dig into this study in order to say whether it's good or not So, thankfully I'm able to do a lot of that myself And then the longer reported things yeah You dig into — I'll spend a lot of time getting to know one particular source and then find that they got all of their funding, you know, on this study on biotin from the Egg Council And that's going to cause a lot of problems

So, it's not just about whether someone seems like they know what they're talking about, but where's their funding coming from and how is that going to appear to a reader Yeah it's extremely complicated But the longer you're in journalism the more you get a good sense of who's trying to sell something, and who's just trying to do science >> Female Speaker: Good One more thing, do you usually put in recommended dosages that the American Heart Association or the FDA would recommend for a specific dietary supplement in your articles? >> James Hamblin: It'd probably be a little too granular

>> Female Speaker: Okay, thank you >> James Hamblin: Yeah >> Paul Coates: There was another lady on the right-hand side and then Naresh >> Female Speaker: Hi, I'm a psychiatric nurse practitioner and what drove me here was my patients asking questions And, like you all mentioned, I have no idea how to how to answer them

But also what you mentioned Dr Hamblin that I've had supplement companies approach me to sell their products online And it seems unethical to do that I'm glad to have these third-party organizations like ConsumerLab that I can now refer patients to But is there any ethical implication or legal implication for providers selling supplements? >> Paul Coates: Do you have any thoughts about that folks? >> Douglas MacKay: It s regulated by your state medical board, and it s different state to state

>> Paul Coates: But do you have any — >> James Hamblin: I mean as a person who is — I would just find it — anyone who's recommending something that they're also selling it's just really hard It's like not like your car salesman can't be honestly giving you information about that car, but I wouldn't trust them as the definitive source on making — you know, are they really telling you everything that you need to know? I would definitely, you know, go talk to other car dealers or other places, and read Consumer Reports, and find, you know, more objective outlets before taking the recommendation of someone who's also selling the product Not to say it can't happen symbiotically >> Paul Coates: Laura? >> Laura MacCleery: So, you know, there is a legitimate role for medical providers that are truly informed about the efficacy research and the risks and medical counterindications — right? — to know about dietary supplements and to be able to inform their patients I think trainings like this are great for filling in some of those gaps, but to become a full expert on, you know, everything the patient might ask you would be a big job

And I think that level of medical knowledge varies widely among providers That's one end of the spectrum someone trying to provide legitimate medical advice Is it worth it to spend your money probiotic for this medical condition? For example, to mention something that we've done some research on, you know, for vaginosis There are some strains that might be helpful, but in general probably not worth your time and money as a sort of dietary daily habit But, you know, more troublingly there are

so many examples of diet books or doctors who are also essentially running a supplement company and selling their name as part of that You know, there's one that hits my Facebook feed with real regularity And the nutrition device is wackadoo and the supplements are like the third thing that they're selling you There's one that we're looking into right now where there's a guy who runs a gambling hotline and basically does tele- counseling for gambling addicts and then also sells a line of supplements that are supposed to help you stop gambling You know? [laughter] So, there's a — it's snake oil

Right? It's chicanery, and that sort of thing it's been going on for a long time And it's just unfortunate that those kinds of practices are allowed to persist by a very loosey-goosey kind of regulatory infrastructure So, I think there's a range of things And I think for those that latter category there are real ethical questions about whether the medical advice that they're providing to their sensible patients is in conflict with their license and complications >> Paul Coates: Todd did you have any comments about this part of it? And others turn off your microphones

Thank you >> Tod Cooperman: Yeah, not in terms of the legality of selling it I defer to more experts on the law there, but we do test those brands also, the professional brands They do tend to be higher quality not guaranteed though We do find problems from time to time

They are a lot more expensive also So, I mean as a physician I would I think it'd be better just recommend something that you know is good and inexpensive, you know, then something that might be good and expense So, that just my two cents on that I would say also the multi-level marketing companies that are out there The Nutralite, Amway, USANA similarly the product the products tend to be higher quality there, but also just, you know, a lot more expensive

>> Paul Coates: Naresh? >> Naresh Chand: Dr Hamblin, you look young MD are you taking any supplements? [laughter] >> Male Speaker: I wondered when a question like that would come >> James Hamblin: I'm thirty-five actually

>> Naresh Chand: Okay? >> James Hamblin: No, I don't — I don't take any, any myself, but I — yeah, I'm fortunate to have access to a good food system [phonetic sp] >> Paul Coates: Good answer Yes, next to Naresh Yep >> Female Speaker: So, this question is for Dr

Hamblin So, I was raised in an area where people don't really trust science very much So, I get a lot of questions when I go back to visit my family about why science keeps changing Like they read coffee's good for you one day coffees bad for you another day And as a researcher I understand why that happens, but what do you think the role of the journalist is in trying to put the information that they're communicating in terms of the whole picture of what's been happening in the past and research

>> James Hamblin: This is like my favorite question I've written about this a few times with one story called New Nutrition Study Changes Nothing Which kind of gets into this like extensively, but there is — there's a problem of the problem of the news cycle Everyone wants something new Everyone wants to be talking about whatever the thing is today, and the editors and writers have to come in and have something new

And a good story is something that changes your perspective Right? That challenges what you already thought No one needs to be told again, Oh, also probably drinking water is better than drinking soda, yet again today Right? We need something new Then the news story would be, Drinking soda, not as bad as you thought

You know, maybe you don't need to be running That is something that's just a good story That's interesting So, how do you square that with actually being the fact that science moves like there is slow twists and turns to it but not something that's going to engage like the whole big general interest audience So, you can find lots of other ways to make stories interesting and good than trying to completely change someone's world view

Which is to highlight an element of it that people don't know enough about, trying to highlight the personal stories behind it, trying to make it funny or entertaining in a way that's not necessarily over-promising or scaring people, and definitely not misinforming Yeah, I could go on and on, but that's a main job of what I think the main thing I think about our job as being is contextualizing It s like I'm going to tell you about this new study that everyone's talking about today, and I'm going to put it in the context of 30 years of knowledge which have been building to this point So, this is not taken in isolation >> Paul Coates: Other questions? Mary you had your — >> Mary Hardy: I had my microphone on

This is a good lead-in to something that I find challenging as both a performer of research, as a provider counseling patients, and as a person making my own individual choices It seems to me that there's a taxonomy or just what I could describe as a typical arc of a story for a dietary supplement And the first time it comes up it's terrible; it's wonderful, brilliant You'll find people who are cured of something Then they look for a new story is — after that's not a new story anymore

Then you start to see that negative stories come It's caused this much harm; it's terrible So, I guess what I'm asking about is this bias or over interpreting both in the positive side but also in the negative side? And I published something in the New England — I mean in the JAMA years ago And when we looked at the consumer extract from our study it left out a huge part of our results It only wants to talk about the negative results, and I'm finding that challenging that, you know, the assessment of risk is risk versus benefit, risk versus opportunity, and the personal choice

How would you address that? All of you in the work that you're doing? Keeping both ends of the spectrum alive without over exaggerating either one >> Laura MacCleery: So, this issue that is — that's a like a wonkier version of the last question in a way It's sort of, you know — and I think it it comes up with dietary supplements Or, as I said I — you know, there's a lot of magical thinking people want to believe that, you know, this cinnamon that tastes good on their pop-tart is actually doing something really beneficial for their health But it also is magical — there's a lot of magical thinking nutrition

Right? So, there's all these trends and diet fads and also thinking And, really, as Dr Hamblin implies dietary advice hasn't changed much in the last 40 years It's basically, you know, eat more vegetables eat, more whole grains, don t — avoid salt, sugar, and saturated fat And you've had a fight maybe over defining fat more precisely

But there isn't sort of a — there's a lot of savvy among brands and among food manufacturers and among dietary supplement manufacturers about how to create that kind of mental permission for someone to go and take something that's just a little bit better for them and think of it as a health food So, you know, the example that I always use veggie sticks You have these little potato sticks And now when I go out to birthday parties for my seven-year-old they'll show up at the party because they're — they wouldn't put a bowl of potato chips there, but there's like a picture of spinach on the front of the package And there's like a dusting of spinach

And they're sort of greenish So, now everyone can eat the veggie sticks It's because we want to eat the potato chips You know? But we want to also feel healthy So, there there's a brilliant sort of exploitation of that, and then there's the rebound effect that was talked about where, you know, you eat something healthy and you think, Oh, I could indulge a little bit more

So, if I have my vote multivitamin how does that affect my overall diet quality? >> Paul Coates: This might — I'm sorry to interrupt you, but this might carry over a little bit into our broader discussion So, what I'd like to do at this point is to thank and congratulate our speakers from this panel and then invite our other panelists from the previous session to come on up And we'll re-engage in some more discussion Thank you [applause]

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