Dietary Supplements: Stories of Regulation, Safety, and Evidence



hi everyone hear me okay yes okay papa welcome to chef easy easy series today we have a little something harder and she will give you an intro on her phone in a little bit I just wanted to do a little our little field of e to SP and our district of Council on science and technology we offer programs exist throughout the year we have about 13 each year so if you like what we do as people go on the website and help donate on to our program today we are turning out something different it will be recreated for using an app what they have so you just type this into your browser you can go and ask live questions as she's speaking and you also upload other people questions if you like them and then at the end during the Q&A session we will go through them and and ask questions from both from the live audience and also with the Shire I am plumbers so maybe you don't want to stand up but still have very presentation so also at the end of the talk I will open up on the same app the session are going evaluations great to go and answer a few questions and then five with the mobile answer will get pre fasted morn arboretum for two so if you go ahead and do that we'll get professor so I will hand this over to us through introduce a group everybody thank you so I just want to start today by giving you a little bit of background about Who I am and what I do so I created pharmacologist and my background is in answer biology and NASA brought out and purple petals particle kinetics or asking I'll tell you what that controls it drug interaction is clinical trials so any of those things spark any questions feel free activated and if you do want to stop in the middle of my talk back and really parking that control devices sorry organism services but if you want to give a little disclaimer we are going to talking about health related subjects today I'm not a medical phenomenon apartment interior so really you need to talk to your doctor and your pharmacist about all health decisions that you make with that said so I just told you that I'm a pharmacologist and not a pharmacist so evidence pharmacology I guess expression water and pharmacology is just barely two studies dress and traumatology comes in two flavors in pharmacokinetics and pharmacodynamics so pharmacodynamics is what a drug does to your body you can upper the down lowers your pill gotcha pharmacokinetics is what body does to the drug so how your body dies and the drug that breaks it down huh disrepair I'm not going to go into a lot of detail on this today but first I want to explain what rough is so drugs are in a category of substances called xenobiotic and this is just any substance that's foreign to your body so this includes drugs medicines pesticides food lenses but importantly what it do not do our excessive nutrients and vitamins minerals and new sorts of things okay so I have a question for you what makes something a poison what makes something stopping the dough that's right yes everything is toxic if you're exposed to much of it that includes water okay so that's something that's important you can mind if we go through restless and for the record that also vitamins and minerals can't overdose on them so this means that anything that you taste whether it's to die for definite or drug has benefit ratio but it must consider when you're making these toilets and this is something that I'm going to talk about a little bit later at the top so now you know what drug is we're seeing a wide opening line so let's talk about that mathematics what is your bottom view when you take into pending substances and particle kinetics is described by this acronym Agni and it's the absorption distribution metabolism and excretion okay so we're going to go through each one of those absorption just picking up or soaking in so that's what mainly happens in your intestines but you can also happen to your skin distribution which is just transportation how's the drug it's throughout your watch so this happens through circulatory system your blood to get there up to the tissues metabolism is the complication or breaking down this happens mostly in your liver which good news everybody you don't need to do that detox about that your liver doesn't do you good and then finally they have excretion which is just a certain out of that drug if your body getting rid of it and that's happened almost entirely in a few million so basically would you take just about anything they're going to go the substance is going to go through whatever pill point where it starts going to get broken down to its active components and then it's going to get inactivated by the body and this is how it happens take the drug and it dissolves your stomach it's going to get absorbed through your intestines and be distributed throughout your body in the circulatory system and that will allow the drugs get into the target tissues wherever that is all of your blood goes through the liver and your level liver will break down the active drugs to the inactive dress and then we'll treat it so that's how it works there's also another lever that sometimes you'll see with acne and that's high and that's for interaction this is a really important topic for today and it means drug interaction so drugs can interfere with other drugs in every part of this a B pathway as you can see over here and it can also interact with other drugs in a drug action type of way this is why you can't take too many stimulus together or why you wouldn't want to take uppers and downers at the same time okay so this is exactly why is it really important for you to tell your doctor and your pharmacist everything that you're taking so that they can mitigate these sorts of dread righteousness and as a really important example of a pharmacokinetic interaction that's really common is interaction that without logging in and have like the enzymes or the molecular machines in your body that's always down drown and when one drug is interfering with those machines they can't purse down another drug right so this is exactly why you should never take acetaminophen or Tylenol with alcohol and it's also why grapefruit juice interacts with a lot of drugs and this is a really important example of a food drug interaction as many of you may probably know about this cause you're probably taking idiot staff maybe an anti system is that you can't drink in a group for two pieces why okay so what does this all have to do with dietary supplements right so as an even by the dietary supplement is products that is intended to supplement your diet and this is generally understood to mean vitamins minerals herbal medicines amino acids as a concise first thing but what's really important to know is things like vitamins and minerals and phytochemicals which are just the temples that are in any plant so anytime you ingest a plant they're ingesting kind of excess okay all of these substances are treated exactly the same in the Boche to other peanut biotic so these sorts of drug interactions and the pharmacokinetics all apply to these substances as well and I want to focus just for a minute on plans because so many people think that plants religious plans and I work on finding to do and so I just want to make a point here is that some of the most important drugs that we have or either discovered in or derived from plants cancer drug heart medications the nerve gas antidote one of the ones I've worked in the past work lives in the past is a clear pathway back to a really important for cancer drug and it's derived from the Pacific yew trees on top of that aside from the fact that we know that all these medications can also be extremely toxic some of the most toxic substances on our planet are in sight allege the things you might recognize cyanide arsenic and write them is maybe one of the most toxic substances on our planet where a dose of purified licensed powder and the castor just view the size of a secret vault is enough to kill a human so plants are not marked and that's the point natural not necessarily mean things and that's why part of the reason that we're going to be talking a lot about plans today some of the supplements that are on the market can be dangerous issues you need to have so let's talk about the scope of the dietary supplement industry in the United States this is approximately a thirty billion dollar a year industry Justin divas and approximately 85,000 supplements on the market but we don't actually know the exact numbers because there's no formal registry which profile a passive about forty nine percent of the u.s. population take dietary supplements and of the entire population when it comes to adult 70% of adults you advisory so specifically 72nd Street are using a dietary met somewhere in the range of 16 to 34 percent and prescription drug users are using dietary supplements at the same time and this is an important point on top of that people taking these drugs embezzlement of the fact 60% of all subsides very supplement users never tell their doctors that they're taking dietary and this is where you can get these are expert people we also know that approximately 20,000 emergency room visits per year in the United States are dietary supplement related so this is why it's important that we're talking about interstate and because the dietary supplement industry is so large it is regulated by our government but maybe not in the way that you expect it to be so the Food and Drug Administration is a regulatory agency that is responsible for protecting and promoting the public health and it was given this power by Congress in 1938 which was passing the Federal Food Drug and Cosmetic Act and this was actually following the tragedy or 100 people died from elixir sulfonamide which was made as diethylene glycol so Congress decided that needing to have regulatory agency and I point this out particularly because this is going to get really important later the FDA says – nothing did not get them the power to do so as this right now the FDA to regulate finished dietary supplement products and dietary ingredients but is a really important point that dietary supplements are not regulated like foods and they are not regulated like that so in the 1990s because the FDA had always had less control over dietary supplements they did attempt to get more power over our dietary supplementation and these are jerks from an industry reacted by launching this year campaign and it actually led to what the current state of our regulatory affairs is which is a dietary supplement health and education act but before we get that I just want to show you the most excellent commercial that was run in 1993 as a part of this smear campaign because the federal government of actions that are classified well cried another drug raid octagon to the help employees deal on you multiply maybe here we go and save your life they never do that yes so so that's excellent commercial a one other tactic was so successful that Congress heard more about this act than they heard about the Vietnam War as a result of that to shave this past so the dietary supplement health and education act did mainly five things we're going to go through each one of them one by one we got a definition of the term dietary supplement because prior to 1994 there was no definition of dietary supplements we got some glycerin requirements it was clarified that the FDA did not have the power to approve these products prior to marketing the FDA did have the power to ensure current good manufacturing practice and it also established the oxidizer assumptions those concepts so this is the definition of the dietary supplement in essence the same as the definition that we talked about before but what I want you to take away from this is how broad this definition is many different kinds of dietary reaches as well as many different forms of supplements ok so we have a definition lately so supplements have a supplement Facts label which is different from a Nutrition Facts label that foods have okay and what I really want you to know we're going to talk later about some specific problems with the labeling aside supplements for analysis takeaway is these dietary values for this supplement which is quite comments many of them are over 100 percent of your daily value and some of them are completely undetermined which is what these practically in here okay and this is super super fun so we'll get back to that later but then importantly because immense carry this warning statement which is these statements have not been evaluated by the FDA this product is not intended to diagnose treat cure or prevent any disease we'll talk about that later too so that's what the labels have to look like as I mentioned by various elements do not have any premarket review so they are not reviewed at all on by the FDA prior speeds around market and but we do require companies to follow with manufacturing practice basically what that means is that there as if this year they're prohibited from marketing products that are adulterated or misbranded there but they're also these companies are also responsible for regulating themselves they choose the quality control standards and they Col long really look at that information okay now the FDA is responsible for taking action against adulterated or misbranded products the FDA can actually inspect supplements manufacturing plants pens but there's a couple things about that number one the FDA can only inspect you if they know that you exist and there's no formal registration for these companies so they don't know walleston number two the FDA has limited resources as far as funding and couple so they can not inspect all of these places but if they do inspect the place and it is under car they can be cited or they can be shut down so that's important it'll come up later the exceptions to all of this is what is considered is called a new dietary ingredient and the dietary ingredient is something that was not in the food supply prior to 1994 if it was considered a new dietary ingredient the company has to tell the FDA that they're going to use it and I have to provide safety gating for that okay that was the month later – and then finally I'm going to give you those resource of in advance because it's a phenomenal resource and that the website could ask the dietary supplements not the office of dietary supplement is again we National Institutes health and they're basically their job is created with all the other government agencies to advise on the dietary supplements and hopefully a to the public so that have really wonderful fact sheets that they pile on dietary supplements that will tell you what we know and we don't know about various kinds of fiber so it's a really important resource and I'll get it back to you at the end so there's no house not so bad right Nina Simone labeling requirements we have a definition now they have to use the manufacturing practice that's not so bad so but I wanted to give to the Commissioner of the FDA at the time these tesslar have this to say about the that vishay does not require the dietary supplements shown to be safe or excessive before they are marketed which is true and the agency is permitted to instruction restricted substance which disposes an unreasonable risk he felt that this was a real public health danger and a basically Congress failing to protect the public eyes and I have to say I do agree to admit so this is the state of the regulatory affairs that we have right now and faced with the omission of the Federal Trade Commission but I want to talk about Federal Trade Commission hurt a little bit so the Federal Trade Commission is a law enforcement agency is basically a law firm that covers all of the United States commerce okay they investigate issues their rate is that false advertising Express that this includes telemarketing and multi-level marketing companies all kind of stuff so considering they are over time to enforce all laws about Commerce and imagine that only a very small portion of the ICP is focused on dietary supplements at all times okay so this is what we thought we've got a regulatory agency the FDA that regulates foods drugs cosmetics devices and supplements and they also review helps thanks again and then we have the extra fee and enforces every advertising and marketing laws as well as anything else that do so the only overlap on these two is the marketing of food strips of medical types of supplements and where things go wrong in this overlap is this and the labeling requirements and advertising requirements are made by the FDA they are enforced by the FTC and both help legs to be clear are illegal in this town but unfortunately they're extremely common and you've all seen them and you're welcome a lot of them so this is what happens when there is a fault sometime first the customer has to complain the FTC if you do not complain the excuse me about a false place they don't know what's happening and they won't do anything about it because they have a lot to do okay if there is sufficient damage being done or concern about the salt salt place the SEC will request from the company their data to support that health plan most companies drop the health plan system okay but if they little drop the health claim at that point if the data that's provided is not sufficient or the data never provided the FCC will then issue a cease-and-desist letter to that company at this point many companies will drop that investment but if they do not the FTC will litigate that company and over the last ten years the FTC has filed 120 cases a challenge in health plans may resemble my guess is no the question was whether competitive competing companies like turned another company my guess is no but I don't actually know that information because these sorts of records I don't think are public as far as like who is making the claim because I release dangerous things of being able to take revenge I doubt it set up something but so they could be growing so for the last ten years 100 funding cases against health claim case to supplement and one of the most recent and maybe was one of the more well-known is that these green coffee beans so green coffee beans have had some publicity on the dr. Oz Show where the claims they were a magic weight-loss soap and it was partially for this reason that he was required to be a percentage subcommittee for commerce to testify again this place and this company has since been shut down for their health claim and most of the customers that participates products have been fully refunded at this point so amazingly companies do fight this and they need coaching so but what's interesting too is that all health plans are not just on supplements they're also on food and other products and one of the most famous food ones that you may have heard of the pom wonderful pomegranate juice this the health claims that they were making about the pomegranate juice they did not have supportive data for and those claims will also shut down so some of the common points that you're going to see weight loss is a really big one boosting your immunity or reducing risk for serious illnesses like prostate cancer heart disease so that's sort of where we are as far as regulation what the actions need to do what the FDA can do so now we're going to do is go through some case studies some of the major five major areas of safety concern like honest assessment all right case study number one February 16 2003 the picture of the Baltimore Orioles the specialer collapses during spring training with his condition thrilled and rushed to the hospital but he died the following day with a body with a body temperature of 108 degrees the medical examiner ruled his best complications of heatstroke with the toxicity of ephedra plan is significantly he was taking a fedra to lose weight before the next Facebook and so professor Petra is a preparation from the plant federer Seneca a las long and Chinese traditional medicine and it contains the ephedra alkaloid ephedra which is an amphetamine and you may recognize the name as being very similar to pseudoephedrine the compound is very similar to a peasant which is an over-the-counter Mabel you speak investment and a stimulant and for those of you raised and bad waters it's also the precursor for the making of Mac as you might imagine there's a lot of serious side effects of alternate ephedrine but the most serious is would to be irregular heartbeat seizures heart attacks and broken sack this is the timeline of how everything happens in the ephedra patients a really good example of what the FDA can do when you're dealing with something that is inherently toxic so there was already sufficient concern about a bedre in 1997 for the FDA to propose a ban of high ephedrine containing supplements and requiring stricter labeling for all remaining sidewalks the following year the dietary supplement industry launched the ephedra education council to fight this regulation and once again they were very successful that by 2000 the FDA's withdrew their proposal for regulation of ephedra products interestingly in that same year an article in the New England Journal of Medicine revealed several cases of sudden cardiac death or severe disabilities resulting from ephedra supplements and importantly this was a federal supplement that people were taking at the recommended dose and for this wasn't like they were taking the whole bottle in 2002 the Department of Justice source the company metabolites which was a major of a very popular ephedra supplements to release the adverse events records that they have approximately 15,000 adverse events that they had failed to provide the FDA a year later be secular guys and after being seeing that data that no one would help them the FDA issued a press release urges customers to not face a federal supplement but it wasn't until 2004 that they would have able to issue a ban on ephedrine containing now what's important here is that piece of our supplements that are banned in the market our supplements that contain ephedrine a plant ephedra is still available in the country so if you are using this plant you have to be extremely careful and keeping it with other stimulants such as caffeine to be very dangerous okay as an icing on top in 2008 co-founder metabolize with the sentence in six months in federal prison for failure to disclose which that's obstructing joy so so ephedra as a situation where we have something that is inherent in tactics our next case cells are going to get into a totally different issue so case I never to you and one last time on in 1991 dozens of young female patients at a Belgian slimming clinic presented with kidney failure after taking a weight loss supplement that was prescribed to their common sense two years later a report links to these cases of 10 nations of the mystical Acastus wasn't until 2000 that another report came out showing that approximately 5% of 1800 women given the birth or plant of the weight loss treatment developed typically failure and urinary tract cancer the next year in 2001 the FDA issued a warning about the products containing worth of folic acid particularly workforce was later discovered that word sport had been added to weight loss capsules in the Belgium case by accident it was supplemented for another plan not knowing the practices and this is actually a really common problem with herbal supplements is that not always a plant on the label the plant is in the box so this is an example of a quality control problem okay mechanical authentication and herbal products is necessary and it's very frequently not done and another good example of this when Justin Tony 15 when the Attorney General of New York with an experiment people federal herbal supplement offers the Shelf of some major companies Walmart Walgreens champion target EKOS just name the important Valyrian circles and they tested the supplements for the DNA content of the plant that was in the label and you can see it as a result for additional at most 41% of the products tested actually has a Frank plant in there what was mostly found was a lot of fillers and unfortunately some mysterious allergens which is a real problem a point that I want to meet here is that his study was actually a bit flawed they tested for DNA content but many of the supplements they tested were extracts and there would be no DNA and an extra if some of the other ones that they were testing work around the group material that can't find any DNA on the plant and not the plants not there so as an important point so if it's an extract would it be at the DNA and so what they also need to be doing both of the Attorney General New York and these companies is testing the DNA of the plant material and the chemical profile of the extract to ensure that what they have is what they may have doesn't want to point out this because there are the larceny products others necessarily mean Express fillers are secluded interests as well which does not like powder but what's interesting is that this is not the only problem with quality control in the data person with industry the other elements that industry seems to have just batch to batch and hilarity so each passionately while they different this would be expected this plants in particular because they're so complicated but even with abundance they're not properly while doing quality control to make sure each of their Baptist licenses so what happened to all this good manufacturing practice I'm talking about right so good manufacturing practice does require that companies ensure that they need said their supplements are not contaminated that they have their correct plants or additives and as the amount is correct but we know that those puzzlement industries in doing this because all of us can go to the grocery store right now and well maybe you don't have a mass spectrometer but I do so I those things and we know that this isn't true a really good example of amounts of vitamin D vitamin D is the most prescribed supplement and we know that some of the amounts in the pills can be double of what they say they are and that may not be a problem for an adult per se but for very small human infants that dose difference can be a huge battle to them because right toxicity is based on melt and amounts are based on so that can change things a lot and as I mentioned earlier the FDA is charged with inspecting these manufacturing plants but as I mentioned earlier although they can cite or close down these manufacturers there's just too many of them to inspect and they can only expect the companies that they don't so what companies can fly under the radar and so farm is yes yes so that's a really important point I'm actually member in out later all addresses right now don't buy products that I manufacture that one of you might see just a bit because you don't know what the requirements are you have no idea what a quality control is happening and spoiler usually there is intention so my recommendation is very careful of your buying supplements online as you don't know where they're coming from and we have a there's a lot of problems with things that are purchased from India and China because they're not regulated they are required to do that so yeah I'll mention that later too but all supplements have their manufacturer and distributor on the bottle that is required by law and in connection with contact with company I'll tell you about that later so quality control and good manufacturing practice are very tightly related to contamination and evaporation so this is case study number three we have several individuals that experience unexplained pain aggression voice changes leading scales hair growth and changes to sexual organ importantly this connection would never have been able to be found if all of these patients didn't happen to be going to the same physician these connections can be very difficult to see so that's an important point in this case session but what's connected then was the use of purity first because D vitamin product interestingly and around the same time that these symptoms started to appear the manufacturer of this supplement was shut down by the FDA for failure to uphold good manufacturing and upon testing the supplement has two different sterilizing so contamination 15 to 25% of all settlement or contaminates with steroids we don't know which ones they are but we do know that the side I know that's that steroids aside two substances that were removed from the market by the FDA our DNA and as the DNA was in Jack and oculi Pro among other things it took 100 illness reports and six deaths before the FDA was able to build the new location necessary Capozzi I may ask the market well pull it off the market but there are really able to do with send warning letters to manufacturers and so they said neat stocks on display and some companies in particular GNC took a very long time to pull those things off of their shelves they continued to sell these products for long period of time until they were forced by the FDA to take stock market DNA you should not be able to find it on the market not on a label anyway but it is something to watch out for especially if you're buying supplements outside of the country now and this is another stimulus ok so there's another thing to be careful of if you're mixing this with other synonyms Angeline and oxyelite pro so may remember this case where dozens of cases of liver damage started popping up in Hawaii and this was actually two liver transplants in one bed before the FDA was able to determine that it was abdomen that was the culprit and that abdomen was actually considered a new dietary ingredients so they actually pulled from the market very well because MTA had never been notified of abuse and there were no state to date on this patent since it was a new dietary ingredient they weren't able to all virtually yeah that's actually the argument without 20,000 mergency room visits is that out of the entire United States that's not very many right and so this is just a real example of buyer beware right right now if it happens to you it's your own fault because you just do the right research right that's sort of the thinking but that's not all is really hot because you know Agilent should have never been in there in the first place there's a weak open the BBS so how are you supposed to know or know there was no information and yeah I mean this is like 50 people here in the 600 100 people but if it's not supposed to be on market in the first place so I also want to make the point that the contamination of five years of illicit drugs heavy metals microbes pesticides and other things are also very and I note about contamination some of these contaminations we consider accidental contamination in a way that certainly what I've heard before Wilson excellent we didn't clean our machines enough after the steroid was being for you but to me this is way lean if at that right because did you even ask your manufacturer if they also produce steroids maybe don't use that manufacturer I don't know you know if you don't have a botanist on staff which most companies do not if you don't have a natural product chemist whose fault is that right is it really an accident okay so other contaminations are purposeful there are contamination and be purple for the reason of if your form of enhancement supplement has errors and if you work some more people will buy it okay so that also happens and there's the other kind of contamination that we see is alcohol and natural contamination and this is the case of metals so plants take up metals from the soil and they concentrate it in their group and we use out and if a company is not measuring those metals and controlling for that dangerous as high as the levels of Medicine be in your company but that was all though the medics couldn't have been added but also this would be a more or less natural contamination and the amounts of metals that kinds of metals is dependent elasticity the plants the location that's growing the soil conditions whole kinds of things so you know one of the things that that's also gets into in that may be the labels on government can't be trusted 100% alright and so our next step going to bring us to our next case study and this case study is specific to a very particular problem and dietary something the labeling and s packaging so we have a fourteen year old female with a no heart condition which is a malfunction of one of the heart valve she consumed to 24-hour monster energy drink the following day she went into cardiac arrest her heart stopped and then she dies six days later the cause of death is ruled to be cardiac arrhythmia a regular beating of the heart you too captain toxicity okay so one can of Monster is 240 milligrams of caffeine so in the 480 milligrams of caffeine which is equivalent to 14 cam cope and its nervous 5 times the limit recommended by the American pediatric Association so caffeine most commonly used central nervous system stimulant in the world right important note here energy drinks our dietary supplements they are not foods like soda okay so they do have a supplement label supplements books includes caffeine as an ingredient if and only if they add techies as an ingredient separately has to be added yes but adds something that has caffeine in it like green tea extract they do not have to label caffeine as an ingredient and more important than that there is no requirement for a total caffeine amount to be on these labels so any supplement that you are taking you have no idea how much caffeine is it so this is an example of an actual monster supplement label and you can see that there is caffeine on there but there's also one of the most common student happening ingredients for honor and in this one you can actually see they have three different sources of caffeine they added 100 and 150 or 80 150 milligrams of caffeine but they also have green tea extracts and your not a okay so okay but how how likely is it that you're actually going to overdose on caffeine right and most of us are probably familiar with caffeine side effects such as lightheadedness maybe some stomach upset these sorts of things are are fairly common but it is actually quite difficult to overdose maccaption you just have to take quite a lot of it unless of course you are a smaller human or you have a heart position okay so as far as caffeine content one cup of coffee has got point one gram the captain minutes we know that a lethal dose is somewhere between six point five and ten grams so that's 65 to 100 cups of coffee so I think it's always safe to say that you're drinking coffee Yorkie you cannot overdose on caffeine but it's not the thing for supplements okay so in 58 different supplements are tested at their daily recommended dose there was a range of zero to point eight milligrams or 0.8 grams of caffeine and o Soniya so it was pretty variable these were all supplements that said that they had caffeine in it by the way because I'm hoping to have some caffeine in as well so again with those supplements unless you're going to follow the whole bottle if you're likely not going to have problems with overdose but okay what sake really really careful with or things like pure caffeine powder liquid caffeine and things like this rediculous biohazard prize I mean that's a lot of caffeine and you also have to be really careful again with mixing caffeine with other stimulus whether it's an amphetamine that's in want to your supplements that you don't know about or some other kind of business education so all of this really leads me to the fact that I personally really think that there should be more important level one dietary supplements I would like to see full total caffeine content plenty supplements um but just more warning labels in general and that brings into this sort of side of the FTC and I'll be a state so last year the FCC released a statement that they were going to crack down on homeopathic medicine labeling or they were going to require these new warning labels that there is no scientific evidence that this product works and this product claims are based only on the theories of homeopathy from the 1700 that are not accepted by most medical experts so as a relative background here homeopathy is based on the idea that a substance that causes a certain symptoms when diluted varies highways will treat that sentence okay so something that causes it if I delude it in water so much that there's nothing left on how that will tree mitching that's what this is okay and to be clear this concept is in direct conflict conflicts with fundamental ideas of cantos of physics chemistry and biology so in short completely absurd okay the industry argues that versus outside of the FCC's jurisdiction because it's not advertising it's labeling the FCC displeased their argument is that they're basing that sockos FDA labeling requirements and that they have the purview to prevent advertising or labeling from being misleading so I also just brought me a lot of joy that is a really good point actually a retail exact second and that was the major so I brought that up because that is actually the major argument against the courtesan and it's the same for that FDA has never reviewed this whatever the thing is review this product or substantiate as a claims orders we have actually a lot of data that suggests that those sorts of warnings don't work and so this actually gets right into my point I think we need to have more specific labeling for various supplements and that brings up second cases so we have to study transplant patients previously they had normal blood levels of the drug they were receiving cyclosporine cyclosporine prevents transplant rejection okay and if they had normal looks all of a sudden both of these subjects are what levels of cycle corn went down practically so that it was no longer working and this resulted in the 29 year old male actually developing which she projections his kidney transplant it was later discovered that they were both taking st. John's wort extract and they were advised to stop taking the excess when they terminated youth the cyclosporine levels returned to therapeutic level okay this case study is that of the best studied herbal supplement of all time and we know a lot about how it works and how thanedars it can be so we're going to spend some time talking about transport so st. John's wort has these beautiful yellow flowers and if those flowering crops that are used in the supplements that are can be prepared as teas have a chapel letting others realisability guilty so they John word is used for mild depression and actually we do know because it's so well studied that st. John's wort is effective for mild depression it's as effective as some antidepressant effect unfortunately st. John's work also inactivates almost all dress and we'll get into that but also a really large market 600 million dollars in 2015 in the United States alone and you know getting back to the point about numbers we first discovered those drug interactions of st. John's wort in the clinic and the only agreement we were able to see it in the clinic is because so many people were taking it and because the drug interaction was so severe if there were less people seeking it or to effective more moderate it would be much harder to see in the planet but also importantly these case studies that first came out with st. John's wort those sorts of studies are not sufficient to tell us that mate on board is causing the problem and I'm going to talk a little bit about different kinds of evidence later but it will directly relate for this so thank John's work what they do so as we talked about before with these drug metabolizing enzymes that are those molecular machines that are breaking down drugs from your body in normal function there is a certain amount of these enzymes that allow enough active drug to be in your body to take effect but also break them down fast enough so that they are talking okay in the presence of st. John's wort your body actually produces more of these machines so that the drug has broken down faster so that there isn't enough drug in your system to take effect and this actually also happens so this is maintenance in the liver that we're talking about right now but this also happens in the intestine so think that we're actually also prevents how much the drug your body can take up in the first place eat your human form so this is one of these fact sheets from the toxin dietary supplements is very useful and I know you can treat this I just wanted you to be able to see what it looks like because it's about three pages long and it provides a lot of information that you would need to know if you were considering things on board so some of the things that it says interactions with st. John's wort will weaken the effects and life-saving medicines and cons dangerous side effects and then in this what do we know about safety section actually lists the whole common types of drugs that it will interact with most I would say one of the more notable ones the birth control the birth control pill is completely inactive in the presence of st. John's wort I also want to point out this little piece of information which is that st. John's wort may cause increased sensitivity to UV radiation Bank on board is phototoxic a lot of other plants are actually also so attractive it makes it more sensitive to UV radiation so if you're using a John's wort or a lot of essential oils you need to be very careful about her exposure to sunlight in tanning beds because you can sustain some very severe burden from Celia music same time okay so as I said this is like one of the best studied herbal it is the best studied herbal supplement of all time we know a lot about it and the vast majority of other herbal supplements we know relatively nothing about what I'm going to talk about now our different kinds of evidence and how meaningful they are so these are sort of the main categories of all kinds of evidence we're going to start with the most common that you're going to see from supplement industry and companies is most likely to give you testimonials so testimonials is when of patients somebody that's using the supplement says this thing is great I like all this way is done testimonials are a single data point they're also very easily terrific and this means they are completely need so I want to give you this example to think about so how many give you 10 testimonial early reviews the supplement is incredible how many people are using their product our 10 good reviews meaningful if there are a thousand or ten thousand reviews if you then found out that there were also 10 people that said that they suffered severe liver damage with those tens of reduce delimiting confuse testimonials are total dimensional so you see this information even though it's really hard right especially when it's like your animal on she says that it's really good okay but keep in mind single data point there is usually just rated mix you have to think about the whole amount of data that's that's collected there okay so next pretty presentable data this is experiments that are done test shoes and cell culture or an animal models this kind of data can be really useful as preliminary basis when they are conducted well and they're well controlled and there's a lot one studies help us really nothing single study is meaningless you have to look at the body of information but the two things that I really want to bring up here the preventable data and dietary supplements are there are two main flaws that I see all the time in the dietary supplement industry and number one is a financial console to deter mass the vast majority of studies that I've seen some supplement in companies are funded by the cub this does not necessarily mean that there's anything wrong with the science the science might actually be good but you need to be more suspicious of studies when it is paid for by the company because are you going to tell your boss of the experiment didn't go the way that they wanted I don't put anything the other thing that I keep all the time in misrepresentation of data to see a plan to boost the immune system and what we have is paper in this pool therapy journal some very science and real funny thing is that when you open up that paper you don't even have to read it you can just read the abstract and the paper itself will say the samel effect but the companies which said that they get here but they're counting on the fact that you won't open the paper because if you actually look at it they will tell you themselves that they saw no effect and that's back to Georgia at the time that I spoke up data that's correct okay so our next section is clinical data now not all clinical data is created equally so we're going to go through each one of these so we're going to start cases just like the case studies that we talked about case studies are a similar situation of a single data point usually one to ten so subject and they can give you some information about what hypothesis you might have for what's going on but it cannot give you a vision and you correlation you cannot daily publishes so we gave ain't John corks like the form levels went down to things on waterways like a foreign SS type up this does not mean that the st. John's wort caused the lower level to cycle for it just suggested we had to do a lot more studies in clinical trials to prove that that was true okay the next level of single arms these are usually looking for a toxic dose of a substance may be looking for drug interaction where we just have one group of subjects and are all doing the same thing this can also be really important preliminary data but is also not sufficient so here we're working with 10 200 subject and we can get some better ideas about causation but still not enough the gold standard and the best type of evidence are randomized double-blind placebo or standard affair control trials now this is a lot of things so we're just going to go through it really quick like this is hundreds to thousands of subjects and all of these words are just waited and preventing bias and respect so we'll talk about each of them so quickly those many of us know that people is like should also know active ingredients it can also be a fake treatment I've got eight acupuncture for example you have to treat all the subjects remove I will actually do what they call a sham or face treatment the problem with this you go is that to see those work for subjective symptoms you know if you wish somebody a sugar girl you can even tell them what you're getting in a sugar tub and they will still tell you that their pain is improved so this is why you need the placebo we need to know whether or not the effective the senior study are due to the placebo or due to the effectiveness of your treat but you can't always do placebo control sometimes it's unethical we cannot for example give cancer patients and placebo right so in those cases they have a standard of care control where you're comparing a new treatment to an ultra is the new treatment better or worse instant ultra okay so that's all those doing randomized simply means that if you have multiple groups treatment versus placebo you randomly select your subjects to go expect group so that you are not unconsciously or consciously selecting certain people to be various apprentice and then the last is double one and that means that neither a doctor nor patient knows who's getting some treatment including four people so all these things control for extreme complexity and biology right yes this is little complexity into the study as we can so that we can really be different and there are some things I want to say about this statistical difference is not clinically relevant necessarily okay statistical relevance is not plentiful relevant they are not the same thing so beware of that because I see that a lot this was statistically significant I don't care is it there's a clinic investment all right so my point with all of this right that I want you all to understand that taking the supplement is no different than anything else everything you do has a risk benefit ratio there is no such thing as a treatment that is both effective and risk for you it doesn't exist okay that's just not the way the biology works there is a risk to everything the important point is what risks are you willing to take in the hope of benefit right we accept the extreme toxicity of chemotherapy because of the severity of cancer we would not accept the same toxicity to treat a headache okay so you have to consider all risks and all benefits that are in the situation and that may just be in the case of many dietary supplements we don't have anything at all they aren't absorb and they don't do anything at all no harm no benefit so the only risk to you in those situations is to your loss like you spent the month already and if that's the risk you're willing to take that time but just consider it okay but the real problem of dietary supplements is that we don't know which ones are which we do not know which one will cause harm until they have already caught and we likely to not know until a lot of harm is done and so rusty you need to consider if you're considering a vibrator this is my list of things that I want you to think about which supplement are you taking and what's actually in the package does the company provide any quality control data do they have independent testing there are labs that do independent testing so if you trust their methods that can make you more confident but there are these not contaminated okay how much of the education do we have any data saying that the amount that they are recommending is basic are you taking any other medication do we know about any drug interactions that may be occurring with these supplements is there any data I will tell you right now that for most of these answers we don't have any data it doesn't fit but most important are using the supplements to diagnose treat cure or prevent disease as I mentioned everything we do has a risk benefit ratio and delay of care can be a very serious risk okay so I have a list of resources and this is going to go up online that you'll be able to pursue top speed but I just want to go through a couple so for general supplement information highly recommend the office of dietary supplements if fact sheets are really good the Mayo Clinic and the University of Maryland also have some good information but I personally feel that it's less well curated and they out information but they do have these taxa I found this MedlinePlus website that actually just has a whole bunch of links on it to good dietary supplement information so I put it in there with a whole bunch of stuff on that page and then even got to this point that we were talking about earlier if you want to know information about a specific product you can contact a manufacturer or distributor that information is on every supplement bottle and you can ask them for the support for the plans of their product and any safety and efficacy data that they may have which they never respond to you that's probably at that time okay the FDA and the ecstacy have great adverse event mornings and consumer warnings and go to their websites and see all their warnings you can also sign up for their emails but I will warn you is sort of an avalanche of information and it's a bit overwhelming I follow many of the FDA accounts and the FTC on Twitter and I also found that the National Center for Complementary and Integrative Health ASB cih has a website of alerts that are more specific to supplement an alternative medicine but they compile from all other agencies so that is actually a really useful tie it's a little bit less information with the other you know with the FDA it could be that all the Commerce in all three okay so the last thing I want to say about resources if you think you are suffering from or have suffered from an adverse event from a dietary subjects please how we FDA if the FDA doesn't know about it they can't do anything the more adverse events they see the easier it is for them to see patterns of harm so first if you think you're suffering from Bernards respect to your doctor initially but second please help yes yay so the FTC if you see a health claim that you think might fall or I mean any other kind of advertisement fraud actually you can tell the SEC about it and as I mentioned before you don't tell the FCC they don't know and they won't act but also if you do tell the SUV here the prep Kirk without a supplement you could get your money back if they litigate that company and there's a settlement don't associate that money to you okay welcome you so with that I just went say that our Research Center has our annual guard want coming up in our medicinal plant card so if you are interested in the different plants you can come visit us on August 11th and get a tour from our our Center members and if you like me our extra 50 novels my to our centers around the deadly plant that we have done music murder weapons throughout history but if you're interested in that that with that I'm going to end on this SP a recommendations for smart supplement shoppers because it's a good list of highlights from today's talk so that that question yes reason so if you are if you have okay just vitamin and mineral deficiencies are extremely rare in this country at this point having lower than recommended levels of vitamins and minerals is not as rare if your doctor prescribes you a vitamin and mineral or mineral supplementation that's something that you should be doing I will tell you I personally do not take any dietary supplement so once a second sorry so we are recording this audio recordings and this will be available online at our youtube channel so your cat has a mic refer to you when you ask the question so that it registers on leather cord so I can reduce the section he was just acting if I know of any companies that have good quality control standards I will say about that is if a company is very new being very efficient the company has been operating for a longer time that's a good time something else you can look for there are independent companies that independently will test summer and they have different requirements but you can look those requirements up to see which verification you want to be more meaningful and you can alter the supplements that carry those outside verification No Stan no that's not company I'm familiar with actually don't just going to do image field report head-on so as I said this will be available on YouTube channel features PCB and we if you have any issues that let's study and you can upload leading up to dirty and like look for that one and we will be going back and forth between live and online questions so that's can get several questions and please do wait for the microphone will have your Lumia wrap do you want to do one of those and then we'll take your question excess so we're not my question what are some common symptoms of a bad interaction so it depends on the drug interaction and so the first hang on sport obviously we had a situation where drugs are inactivated there are situations obviously the exact opposite is true where the drugs are metabolized flackville so there's more drug in your system and those sorts of overdosing is specific to the drug so I can't really give you common symptoms but that because it could be anything but and then when we're talking about pharmacodynamics drug interaction it would be it could be two things either you're taking for example two stimulus at the same time so you're going to have breaking hearts and sweating you know these sorts of things whether you're going to be taking two things at the same time like if you are a medication to lower your blood pressure and you're taking a supplement that increases your blood pressure it's going to negate that dress so it's always difficult to give common symptoms because it's very dependent on what you're taking and what the interaction so I state your bio that is best era troll-like national cancer treatment but I'm holding element I believe that that was promoted at one time and it's still a time from sort of my fixation properties and if you don't take any supplements I gather you don't believe that and then but like no other the other thing ever know is what if you know anything about her purpose which is promoted as fighting Alzheimer's or the very commonly used as opposed to means enjoy and there's some others the health device yes absolutely so it's funny that you mention dressed Erica on perfume in a post in the same breath because as I have a very similar answer for the two of them these are what we call problem compounds that in studies they show positive results all the time for all kinds of different things the reality isn't that they just don't do something specific with respect all anti-aging is what it was counted for and oddly enough that's what my P I used to work on so I can create a finally say that I've reviewed that data curcumin does nothing and then for what both mean and chondroitin there is actually a lot of studies you might just thinking of collagen as the other one that's a really common one that's also taken for joint pain uh so these all are are for the data is pretty clear on glucosamine and chondroitin we have quite a lot of it and it does work and collagen is sort of interesting because it's an up-and-coming supplement you know these things they go in and out of fashion just like anything else and collagen is a protein so if you think approaching orally just like when you eat baked it breaks down in your stomach I can't do anything different from the protein you taken in your diet it's not different so that also there is no data on collagen I'll say but it's very impossible because there's been mechanisms of making sense but yes what are coming bubbly those pillars environment use because of the most common one is rice powder so fillers are a place two different things without about fillers sometimes fillers are used as a formulation it holds the products together so that it can be in tablet form or something like that okay so sometimes that's what I meant when I said that filler is not necessarily broad because it may just be that in the manufacturing process they needed that filler in order to get everything mixed properly and what-have-you with that said in that particular situation of the Attorney General of New York some of those supplements only had rice powder in them so in that case it is Brad where they're telling you that something's in there and they just cook rice powder so it could be both so that you're entirely overzealous with quality control of different products and at the time I really only huge person center and my question is in regards to dealing with the manufacturer so the company butterflying these products I should also ask you if you all put a few it asked about their good minimal because yeah I'll agree a serious but I was really disappointed with the way that they responded so I usually would get a letter that that case it was like a letter of Paul to control saying yes we make sure that our product is going thank you you know and then I actually had an argument with somebody because they would not I like I want to see the heavy metal lows are in your in your batches and they were like no if we're not going to send that to you that's not for you to you and if no way and she's like even if I sent it to you you wouldn't even understand it and hi I was see a nutritionally mistreated out like I just want know what it is this is preventive standards because I want some you just are an immense entity so I guess experiences having how to get advice about that particular don't use the company okay that's why I'm but I mean really really no other good advice because and the other thing with quality control now when it comes to heavy metals and things we have certain amounts that we know alien ounce that are safe right but with other things that they may have in their product you don't have those numbers and so they control their quality control right and so even if they were to say oh we have this amount of whatever in our product that doesn't necessarily tell you much with having metal obviously how much is anger so that would tell you but I can almost guarantee you that they don't have that data that's why they didn't send it to you because they can't measure you know heck metals are sort of a different special category because you have to have a different kind of mass spectrometer in order to measure those and so I kind of have that they have that information but the only real advice I can give you on that is that they will not share that information do not keep them and honestly I don't know how many companies will give you that data I am sure there are some because you know although I've been very critical today there are companies out there that they just really believe that supplementation is important and they're trying to do a good thing they're trying to help people with a healthier life these you know so there are companies out there that really are doing this quality control what I just don't personally know which ones are rich and you know if you have to send out a thousand requests to get one would respond then at least you know when the company's but it's a lot giving a question oils grapefruit juice interacting with drugs great question so grapefruit juice and other two electrics and other pitches as a particular compound in it and that compound believed that the opposite of what pain transport does so st. John's wort increases the breakdown the drug and this prevents it and so when you are taking ripe fruit of ingesting breaking grapefruit juice this particular compound in grapefruit juice bind to and inhibit those drug metabolizing enzymes and it's the environment that drought that metabolites 70% of all drugs so this is a very severe interaction and that I just learned the other day that I did not know is that drinking grapefruit juice can cause this interaction for a full 72 hours after ingestion so this is very severe interaction actually hi I know how Optive wrote a book about all this kind of stuff and he pretty much said the only things that seem to have any kind of evidence or like pointing taking them to do a good version are the calcium vitamin C folate and fish oil or materials like you have an attraction for that yeah that's a great segue yeah as you have a rec hall book I had recommend it it's a great list calcium absolutely at what with the caveat of if you are if you are getting lower than recommended daily doses of calcium and vitamin C supplementation is very useful bollocks absolutely it's really important for women who are on the Asian menu become pregnant and all of those the vitamin C and folate are certified in our in our food source so that has helped actually in the United States with deficiencies upon oh okay so there's the things that visual so the thing about fish oil is omega-3 fatty right it's better to get it from fish and the reason is is that one you don't absorb the Omega threes as well if you take a supplement then if you just eat the fish and the other is that many fish oil supplements are oxidized so they're basically rancid and that is not good for you so if you can just do with the doctor it is better to just eat it but having the omega-3 fatty acids that are in fish that was absolutely how does the consumer know what claims are true to report to the FTC for Sony okay goodbye yeah doesn't individual consumer know what claims are true to report them into that a QP that's an interesting point so you can ask a company for their data but if that company is saying things like wait walk be suspicious if they are saying boost your immunity that doesn't mean anything because that literally has no system kind of thing so if they're saying that it's a salt salt plane okay what are some other common sense that we first Oh probiotics or different things energy yeah so energy usually just means that they stop this cold happiness for but usually with that memory iifa the SSB anything that actually helps memory so fair fair so okay here's what I'm saying sometimes and I did forget to say but I'm going to set this to false health claims are not always the company just sand snakes okay sometimes it's just over excitement of a marketing theme sometimes it's misunderstanding the research but their real chance so what happens often is to do boosting immunity or similar things is that they measure a biomarker of whatever and they say oh this went up that includes immunity okay but that doesn't necessarily correlate to your immune system functioning better okay so sometimes it's just misconstruing whether intentional and then other times it's just straight out there they're trying to sell product until the claim gets shut down basically so one of my favorites with you guys remember that your baby can read pain a system that got litigated by the FCC and sort of got their money back that was not true so you know there's all kinds of product fidgets Center budget centers were originally out to help with ADHD and autism that was the original health plan so if you've never seen that because I got shut down as well we have time for one more question so yeah so centered silver is a multivitamin dietary supplement right typically for older results so here's the thing I know about multivitamin supplements in general is that they don't do any harm but they also don't give you any benefit this is not true for older results and for people that do have deficiencies so various weak people that had gastric bypass surgery happen are not commitment and things like that so multi-vitamin can be very useful for older adults if your doctor says that you need that specification and that's a conversation that you can have with your doctor and your pharmacist but for the regular population multivitamins do per minute thank you so much so one a little reminder so if you do go to that website again the one that you've been using I will be turning on position evaluation and then you can go and enter a question and five you that answer the question and enter your your email at the end we will choose by many people to receive free tickets to the Morton Arboretum for two so let me just go on Joyner he will see what it's your easy and it will pop up right when you go on there it will pop up it will be a big blue button and you can do that tonight or tomorrow and then we'll close it after that so thank you so much for coming and let's thank dr. Elissa here and her presentation and and her slides with all of those links that she has will be available on our YouTube site and size each of you TV thank you for coming

1 Comment

  1. Lovely content! Keep it up!

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