Pets Deserve Evidence-Based Medicine, Too, Says The SkeptVet
Hundreds of Babies Reported Harmed by Homeopathic Product
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Target High-Risk Homeopathic Remedies","publishDate":1513952611,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"site":"futureofyou"},"content":"\u003cp>U.S. health officials plan to crack down on a growing number of unproven alternative remedies, focusing on products containing dangerous ingredients that have occasionally been linked to serious injury and death.H\u003c/p>\n\u003cp>The Food and Drug Administration on Monday issued a new proposal for regulating homeopathic medicines that have long been on the fringe of mainstream medicine. The agency plans to target products that pose the biggest safety risks, including those marketed for children or for serious diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">'People may be putting their trust and money in therapies that bring little or no benefit in combating their ailments, or worse — in products that may cause serious and even irreparable harm.'\u003ccite>Dr. Scott Gottlieb,FDA Commissioner \u003c/cite>\u003c/aside>\n\u003cp>But under the government's framework, the vast majority of low-risk products would remain on the market. Popular homeopathic brands include Zicam Allergy Relief and Cold-Eeze.\u003c/p>\n\u003cp>Long regarded by scientists as a form of modern-day snake oil, homeopathic products are treated as drugs under law, but not supported by modern science. Most remedies contain heavily diluted drugs, vitamins and minerals.\u003c/p>\n\u003cp>\"People may be putting their trust and money in therapies that bring little or no benefit in combating their ailments, or worse — in products that may cause serious and even irreparable harm,\" FDA Commissioner Dr. Scott Gottlieb said Monday on a call with reporters.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Once a niche market, homeopathy products have grown into a $3 billion industry, according to FDA figures.\u003c/p>\n\u003cp>[contextly_sidebar id=\"Q9e3dS7jG2DTfAP33rG2lSzTZoSCLrmc\"]Homeopathic products are similar to dietary supplements, in that the FDA does not review their safety or effectiveness before they are sold. But unlike supplements, homeopathic medicines can state that they are intended for specific medical symptoms and conditions, similar to drugs.\u003c/p>\n\u003cp>A handful of products in recent years have been subject to major safety problems, usually involving potentially toxic ingredients.\u003c/p>\n\u003cp>Last year, the FDA warned consumers about the risks of teething tablets marketed by Hyland's Homeopathic after they were tied to seizures and deaths in infants and children. FDA testing later confirmed the products contained high levels of belladonna, also called nightshade, a poisonous herb that has long been used at low dosages in homeopathic medicine. The products were recalled in April.\u003c/p>\n\u003cp>In 2009, the FDA ordered Zicam to stop marketing three products that contained zinc gluconate after more than 100 users reported losing their sense of smell. Other dangerous ingredients used in homeopathy products include nux vomica, which contains strychnine. Regulators have issued five warning letters this year to companies selling products with nightshade or nux vomica.\u003c/p>\n\u003cp>[contextly_sidebar id=\"OurndJopkYzHm3JfeuY4ygYnj1JktcTX\"]The FDA said its proposal also targets products that claim to treat serious diseases like cancer, or are administered via unconventional routes such as injection or eye drops. Regulators can issue warning letters, seize products or pursue criminal action against companies that disregard federal guidelines.\u003c/p>\n\u003cp>The agency will take comments on its proposal for 90 days before beginning to finalize the plan.\u003c/p>\n\u003cp>Consumer advocates said the FDA plan makes sense for products that are mostly harmless, but can be dangerous if manufacturers stray from traditional ingredients, dosing and manufacturing.\u003c/p>\n\u003cp>\"I think the rules do a good job of going after the things that are most problematic,\" said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center.\u003c/p>\n\u003cp>The FDA hasn't updated its regulations for homeopathic medicine since 1988, when it essentially exempted the industry from basic production standards that are mandatory for traditional drugs, like listing ingredients on product labels.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Hundreds of homeopathic remedies today are sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. The National Institutes of Health has said there's little evidence that homeopathic medicine is effective for treating any specific condition.\u003c/p>\n\n","blocks":[],"excerpt":"Health officials plan to crack down on a growing number of unproven alternative remedies, focusing on products containing dangerous ingredients occasionally linked to serious injury and death.","status":"publish","parent":0,"modified":1513961069,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":18,"wordCount":626},"headData":{"title":"FDA to Target High-Risk Homeopathic Remedies | KQED","description":"Health officials plan to crack down on a growing number of unproven alternative remedies, focusing on products containing dangerous ingredients occasionally linked to serious injury and death.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA to Target High-Risk Homeopathic Remedies","datePublished":"2017-12-22T14:23:31.000Z","dateModified":"2017-12-22T16:44:29.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"437938 https://ww2.kqed.org/futureofyou/?p=437938","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/12/22/fda-to-target-high-risk-homeopathic-remedies/","disqusTitle":"FDA to Target High-Risk Homeopathic Remedies","nprByline":"Matthew Perrone\u003c/br>Associated Press","path":"/futureofyou/437938/fda-to-target-high-risk-homeopathic-remedies","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>U.S. health officials plan to crack down on a growing number of unproven alternative remedies, focusing on products containing dangerous ingredients that have occasionally been linked to serious injury and death.H\u003c/p>\n\u003cp>The Food and Drug Administration on Monday issued a new proposal for regulating homeopathic medicines that have long been on the fringe of mainstream medicine. The agency plans to target products that pose the biggest safety risks, including those marketed for children or for serious diseases.\u003c/p>\n\u003caside class=\"pullquote alignright\">'People may be putting their trust and money in therapies that bring little or no benefit in combating their ailments, or worse — in products that may cause serious and even irreparable harm.'\u003ccite>Dr. Scott Gottlieb,FDA Commissioner \u003c/cite>\u003c/aside>\n\u003cp>But under the government's framework, the vast majority of low-risk products would remain on the market. Popular homeopathic brands include Zicam Allergy Relief and Cold-Eeze.\u003c/p>\n\u003cp>Long regarded by scientists as a form of modern-day snake oil, homeopathic products are treated as drugs under law, but not supported by modern science. Most remedies contain heavily diluted drugs, vitamins and minerals.\u003c/p>\n\u003cp>\"People may be putting their trust and money in therapies that bring little or no benefit in combating their ailments, or worse — in products that may cause serious and even irreparable harm,\" FDA Commissioner Dr. Scott Gottlieb said Monday on a call with reporters.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Once a niche market, homeopathy products have grown into a $3 billion industry, according to FDA figures.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Homeopathic products are similar to dietary supplements, in that the FDA does not review their safety or effectiveness before they are sold. But unlike supplements, homeopathic medicines can state that they are intended for specific medical symptoms and conditions, similar to drugs.\u003c/p>\n\u003cp>A handful of products in recent years have been subject to major safety problems, usually involving potentially toxic ingredients.\u003c/p>\n\u003cp>Last year, the FDA warned consumers about the risks of teething tablets marketed by Hyland's Homeopathic after they were tied to seizures and deaths in infants and children. FDA testing later confirmed the products contained high levels of belladonna, also called nightshade, a poisonous herb that has long been used at low dosages in homeopathic medicine. The products were recalled in April.\u003c/p>\n\u003cp>In 2009, the FDA ordered Zicam to stop marketing three products that contained zinc gluconate after more than 100 users reported losing their sense of smell. Other dangerous ingredients used in homeopathy products include nux vomica, which contains strychnine. Regulators have issued five warning letters this year to companies selling products with nightshade or nux vomica.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>The FDA said its proposal also targets products that claim to treat serious diseases like cancer, or are administered via unconventional routes such as injection or eye drops. Regulators can issue warning letters, seize products or pursue criminal action against companies that disregard federal guidelines.\u003c/p>\n\u003cp>The agency will take comments on its proposal for 90 days before beginning to finalize the plan.\u003c/p>\n\u003cp>Consumer advocates said the FDA plan makes sense for products that are mostly harmless, but can be dangerous if manufacturers stray from traditional ingredients, dosing and manufacturing.\u003c/p>\n\u003cp>\"I think the rules do a good job of going after the things that are most problematic,\" said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center.\u003c/p>\n\u003cp>The FDA hasn't updated its regulations for homeopathic medicine since 1988, when it essentially exempted the industry from basic production standards that are mandatory for traditional drugs, like listing ingredients on product labels.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Hundreds of homeopathic remedies today are sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. The National Institutes of Health has said there's little evidence that homeopathic medicine is effective for treating any specific condition.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/437938/fda-to-target-high-risk-homeopathic-remedies","authors":["byline_futureofyou_437938"],"categories":["futureofyou_452","futureofyou_1062"],"tags":["futureofyou_972","futureofyou_38","futureofyou_1192"],"featImg":"futureofyou_437939","label":"futureofyou"},"futureofyou_435189":{"type":"posts","id":"futureofyou_435189","meta":{"index":"posts_1591205157","site":"futureofyou","id":"435189","score":null,"sort":[1504681305000]},"guestAuthors":[],"slug":"pets-deserve-evidence-based-medicine-too-says-the-skeptvet","title":"Pets Deserve Evidence-Based Medicine, Too, Says The SkeptVet","publishDate":1504681305,"format":"standard","headTitle":"KQED Future of You | KQED Science","labelTerm":{"term":1097,"site":"futureofyou"},"content":"\u003cp>Hunting for good medical advice for your ailing kitty or pup? You'll find no shortage of ardent testimonials and ads for sketchy or unproven treatments on the Web.\u003c/p>\n\u003cp>Silicon Valley veterinarian Brennen McKenzie worries that some of the same pseudoscience that is \u003ca href=\"http://www.npr.org/sections/health-shots/2017/07/17/537711453/seeking-online-medical-advice-googles-top-results-arent-always-on-target\">rampant in human medicine\u003c/a> is leading pet owners astray.\u003c/p>\n\u003cp>McKenzie's blog, \u003ca href=\"http://skeptvet.com/Blog/\">The SkeptVet\u003c/a>, aims to bring a calm voice of evidence-based skepticism in analyzing medical options for dogs and cats. McKenzie works at the Adobe Animal Hospital in Los Altos, Calif., and is a past president of the \u003ca href=\"https://ebvma.org/\">Evidence-Based Veterinary Medicine Association\u003c/a>. Once a researcher who studied monkey behavior, he earned his veterinary medicine degree from the University of Pennsylvania in 2001.\u003c/p>\n\u003cp>The SkeptVet is a labor of love; McKenzie gets no outside funding for it. I recently spoke with him about blogging, pseudoscience and his 19-year-old pet corn snake. The interview has been edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>Why does the world need skeptical veterinarians?\u003c/strong>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Pet owners need to know the pros and cons of health care options for their pets to make good decisions. \"Skeptic\" doesn't mean someone who automatically rejects new or unfamiliar ideas. It's someone who refrains from judging a claim until they have examined the evidence dispassionately — someone who gives preference to scientific evidence over personal experience, anecdote, tradition or history.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think the biggest misconception is that there is a simple, across-the-board, right answer to if and when you should neuter your pet. That's not the case, because biology is too complex for that.'\u003ccite>Brennen McKenzie, Veterinarian and author of The SkeptVet blog\u003c/cite>\u003c/aside>\n\u003cp>That's particularly critical on the Internet, where information about alternative therapies is most often marketing information. Or it's provided by people who obviously believe in these therapies and don't necessarily want to disclose their limitations. Pet owners who have a negative experience with a therapy rarely bother to tell anybody else about it.\u003c/p>\n\u003cp>\u003cstrong>In your writings, you speak out a lot against veterinary pseudoscience. What are some examples?\u003c/strong>\u003c/p>\n\u003cp>Pseudoscience takes the form both of recommending things that are not helpful and discouraging the use of things that are. There are certain therapies that we know are not helpful because there's been adequate research and study showing that. A classic example is \u003ca href=\"http://www.npr.org/sections/health-shots/2016/12/02/504004506/time-for-homeopathic-remedies-to-prove-that-they-work\">homeopathic remedies\u003c/a>, which true believers will argue can cure cancer, autoimmune disease or almost any illness, in both pets and in people.\u003c/p>\n\u003cp>\u003ca href=\"https://nccih.nih.gov/health/homeopathy\">Homeopathy\u003c/a> makes the claim that administering a substance that triggers disease symptoms can have curative powers, if it's diluted in water or alcohol to the point where none of it actually remains. The substance can be nearly anything — from a plant or animal to moonlight or a piece of the Berlin Wall. Homeopathy has never been shown to be useful in good-quality scientific studies.\u003c/p>\n\u003cp>These homeopathic products are available over the counter in most pharmacies despite being useless, because they are generally considered harmless (except, of course, when used as a substitute for effective medical treatment). Any direct harm of homeopathic remedies typically comes from improper production, which leads to biologically significant levels of the original material or to contaminants. That is uncommon, although of course it does occur.\u003c/p>\n\u003cp>On the flip side is pseudoscience that undermines what we know about science-based medicine. Take anti-vaccine activism: Some people claim that \u003ca href=\"http://skeptvet.com/Blog/2014/11/rabies-vaccines-aggression-in-dogs-pure-pseudoscientific-fear-mongering/\">veterinary vaccines\u003c/a> should be avoided because their risks are greater than their benefits and they cause all sorts of horrible diseases. But there's no evidence that vaccines actually do that.\u003c/p>\n\u003cp>\u003cstrong>What about widely used conventional treatments in veterinary medicine? Are there any that you think aren't warranted?\u003c/strong>\u003c/p>\n\u003cp>[contextly_sidebar id=\"Dg10cOLAGl70eg0BwDQjnHscBwgbn3wB\"]Sure. I mean, the beauty and frustration of science is that it progresses over time and that things that we believe at one point may not turn out to be true later. Or that as we refine our knowledge, we have to give up things that we believe in. There are definitely practices like that in conventional, science-based medicine.\u003c/p>\n\u003cp>One example is annual boosters of core veterinary vaccines for animals. Science has shown for quite a while that yearly boosters for certain specific diseases, such as distemper and parvovirus, are unproductive. It's not clear that it's harmful, but it's certainly not needed. I think that conventional veterinarians have been slow to give that up.\u003c/p>\n\u003cp>\u003cstrong>You've blogged about how there are a lot of misconceptions about the pros and cons of \u003c/strong>\u003ca href=\"http://skeptvet.com/Blog/2013/04/benefits-and-risks-of-neutering-an-evidence-based-approach/\">\u003cstrong>neutering a pet\u003c/strong>\u003c/a>\u003cstrong>. Where do people go wrong there?\u003c/strong>\u003c/p>\n\u003cp>I think the biggest misconception is that there is a simple, across-the-board, right answer to if and when you should neuter your pet. That's not the case, because biology is too complex for that. Broad rules such as \"every dog should be neutered at six months,\" or \"no pet should be neutered at all\" — none of those are justifiable because the answer is, frustratingly, \"It depends.\" It depends on the breed, on the age, on the particular balance of risks and benefits that you're talking about. The reality is that you should have a lengthy, nuanced discussion with your veterinarian about that.\u003c/p>\n\u003cp>\u003cstrong>Lots of pet owners will swear that their animals benefited from an alternative therapy, whether it's turmeric or \u003c/strong>\u003ca href=\"http://www.npr.org/sections/health-shots/2017/07/04/535060331/some-marijuana-derived-treatments-aim-to-soothe-skittish-pets\">\u003cstrong>cannabis-based extracts\u003c/strong>\u003c/a>\u003cstrong>. What's the trouble with relying on these anecdotes?\u003c/strong>\u003c/p>\n\u003cp>It's totally understandable why those kinds of experiences are compelling. But things that look to us like simple, straightforward relationships may not be. You know, the classic example is, every time I wash my car, it rains. We know that that is not a reasonable cause-and-effect relationship, because we understand how the weather works. But there were times in history when people believed that your personal actions could influence the weather.\u003c/p>\n\u003cp>Medicine is incredibly complex, and it is very difficult to identify a true response to a treatment simply by watching to see what happens, based only on our personal observations. Because there are so many factors involved in what happens next. And that's the reason why we have research studies that make an effort to control for sources of error. We know that science works better, because our own individual judgment and \u003ca href=\"http://skeptvet.com/Blog/2015/02/dont-believe-your-eyes-or-your-brain/\">observations are not reliable\u003c/a>.\u003c/p>\n\u003cp>\u003cstrong>What feedback do you get from readers?\u003c/strong>\u003c/p>\n\u003cp>With any controversial topic, I get a ton of \u003ca href=\"http://skeptvet.com/Blog/2015/05/skeptvet-gets-hate-mail-update-2015/\">hate mail\u003c/a>. A regular stream of \"How dare you — this worked for me and you're just awful\" or \"You're a tool of the pharmaceutical industry.\" But I also get a lot of people who write, \"Oh, thank God, finally, somebody is willing to ask questions or be critical of these things,\" because it's often so unpopular to do so.\u003c/p>\n\u003cp>\u003cstrong>Do you have pets?\u003c/strong>\u003c/p>\n\u003cp>I have two dogs: Max, a 10-year-old Boston terrier, and Brodie, a 4-year-old mutt from the shelter. And I have a 19-year-old corn snake named Tess. My wife, who is both afraid of snakes and a wonderfully supportive person, bought me a snake when I was in vet school because I wanted to learn more about exotic pets. I don't think she realized that corn snakes can live well into their 20s.\u003c/p>\n\u003cp>\u003cstrong>Have you ever tried a therapy for your pets that didn't have much scientific evidence behind it?\u003c/strong>\u003c/p>\n\u003cp>I previously had some dogs who were older and had arthritis, around when I first started practicing veterinary medicine. I put one of them on glucosamine because more experienced colleagues said it was helpful. I hadn't yet started looking at evidence-based medicine. I did not perceive any change in my dog, and overall, the scientific evidence of meaningful benefit from glucosamine is very weak.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>But being a skeptic doesn't mean that I'm saying people should never use these kinds of things. There are definitely circumstances where trying something for which there is very little evidence is totally appropriate. I'm simply saying that pet owners need to be fully informed about the uncertainty and risks and benefits involved.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Pets+Deserve+Evidence-Based+Medicine%2C+Too%2C+Says+The+SkeptVet&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n","blocks":[],"excerpt":"Veterinarian Brennen McKenzie writes The SkeptVet, a blog that pushes for evidence-based medicine instead of relying on tradition, anecdotes or pseudoscience in the treatment of cats and dogs.","status":"publish","parent":0,"modified":1504645258,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":29,"wordCount":1367},"headData":{"title":"Pets Deserve Evidence-Based Medicine, Too, Says The SkeptVet | KQED","description":"Veterinarian Brennen McKenzie writes The SkeptVet, a blog that pushes for evidence-based medicine instead of relying on tradition, anecdotes or pseudoscience in the treatment of cats and dogs.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Pets Deserve Evidence-Based Medicine, Too, Says The SkeptVet","datePublished":"2017-09-06T07:01:45.000Z","dateModified":"2017-09-05T21:00:58.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"435189 https://ww2.kqed.org/futureofyou/?p=435189","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/09/06/pets-deserve-evidence-based-medicine-too-says-the-skeptvet/","disqusTitle":"Pets Deserve Evidence-Based Medicine, Too, Says The SkeptVet","nprImageCredit":"katoosha","nprByline":"Ingfei Chen\u003c/br>NPR Shots","nprImageAgency":"iStockphoto/Getty Images","nprStoryId":"547420275","nprApiLink":"http://api.npr.org/query?id=547420275&apiKey=MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004","nprHtmlLink":"http://www.npr.org/sections/health-shots/2017/09/03/547420275/pets-deserve-evidence-based-medicine-too-says-the-skeptvet?ft=nprml&f=547420275","nprRetrievedStory":"1","nprPubDate":"Sun, 03 Sep 2017 07:37:00 -0400","nprStoryDate":"Sun, 03 Sep 2017 06:00:22 -0400","nprLastModifiedDate":"Sun, 03 Sep 2017 07:37:06 -0400","path":"/futureofyou/435189/pets-deserve-evidence-based-medicine-too-says-the-skeptvet","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Hunting for good medical advice for your ailing kitty or pup? You'll find no shortage of ardent testimonials and ads for sketchy or unproven treatments on the Web.\u003c/p>\n\u003cp>Silicon Valley veterinarian Brennen McKenzie worries that some of the same pseudoscience that is \u003ca href=\"http://www.npr.org/sections/health-shots/2017/07/17/537711453/seeking-online-medical-advice-googles-top-results-arent-always-on-target\">rampant in human medicine\u003c/a> is leading pet owners astray.\u003c/p>\n\u003cp>McKenzie's blog, \u003ca href=\"http://skeptvet.com/Blog/\">The SkeptVet\u003c/a>, aims to bring a calm voice of evidence-based skepticism in analyzing medical options for dogs and cats. McKenzie works at the Adobe Animal Hospital in Los Altos, Calif., and is a past president of the \u003ca href=\"https://ebvma.org/\">Evidence-Based Veterinary Medicine Association\u003c/a>. Once a researcher who studied monkey behavior, he earned his veterinary medicine degree from the University of Pennsylvania in 2001.\u003c/p>\n\u003cp>The SkeptVet is a labor of love; McKenzie gets no outside funding for it. I recently spoke with him about blogging, pseudoscience and his 19-year-old pet corn snake. The interview has been edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>Why does the world need skeptical veterinarians?\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Pet owners need to know the pros and cons of health care options for their pets to make good decisions. \"Skeptic\" doesn't mean someone who automatically rejects new or unfamiliar ideas. It's someone who refrains from judging a claim until they have examined the evidence dispassionately — someone who gives preference to scientific evidence over personal experience, anecdote, tradition or history.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I think the biggest misconception is that there is a simple, across-the-board, right answer to if and when you should neuter your pet. That's not the case, because biology is too complex for that.'\u003ccite>Brennen McKenzie, Veterinarian and author of The SkeptVet blog\u003c/cite>\u003c/aside>\n\u003cp>That's particularly critical on the Internet, where information about alternative therapies is most often marketing information. Or it's provided by people who obviously believe in these therapies and don't necessarily want to disclose their limitations. Pet owners who have a negative experience with a therapy rarely bother to tell anybody else about it.\u003c/p>\n\u003cp>\u003cstrong>In your writings, you speak out a lot against veterinary pseudoscience. What are some examples?\u003c/strong>\u003c/p>\n\u003cp>Pseudoscience takes the form both of recommending things that are not helpful and discouraging the use of things that are. There are certain therapies that we know are not helpful because there's been adequate research and study showing that. A classic example is \u003ca href=\"http://www.npr.org/sections/health-shots/2016/12/02/504004506/time-for-homeopathic-remedies-to-prove-that-they-work\">homeopathic remedies\u003c/a>, which true believers will argue can cure cancer, autoimmune disease or almost any illness, in both pets and in people.\u003c/p>\n\u003cp>\u003ca href=\"https://nccih.nih.gov/health/homeopathy\">Homeopathy\u003c/a> makes the claim that administering a substance that triggers disease symptoms can have curative powers, if it's diluted in water or alcohol to the point where none of it actually remains. The substance can be nearly anything — from a plant or animal to moonlight or a piece of the Berlin Wall. Homeopathy has never been shown to be useful in good-quality scientific studies.\u003c/p>\n\u003cp>These homeopathic products are available over the counter in most pharmacies despite being useless, because they are generally considered harmless (except, of course, when used as a substitute for effective medical treatment). Any direct harm of homeopathic remedies typically comes from improper production, which leads to biologically significant levels of the original material or to contaminants. That is uncommon, although of course it does occur.\u003c/p>\n\u003cp>On the flip side is pseudoscience that undermines what we know about science-based medicine. Take anti-vaccine activism: Some people claim that \u003ca href=\"http://skeptvet.com/Blog/2014/11/rabies-vaccines-aggression-in-dogs-pure-pseudoscientific-fear-mongering/\">veterinary vaccines\u003c/a> should be avoided because their risks are greater than their benefits and they cause all sorts of horrible diseases. But there's no evidence that vaccines actually do that.\u003c/p>\n\u003cp>\u003cstrong>What about widely used conventional treatments in veterinary medicine? Are there any that you think aren't warranted?\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Sure. I mean, the beauty and frustration of science is that it progresses over time and that things that we believe at one point may not turn out to be true later. Or that as we refine our knowledge, we have to give up things that we believe in. There are definitely practices like that in conventional, science-based medicine.\u003c/p>\n\u003cp>One example is annual boosters of core veterinary vaccines for animals. Science has shown for quite a while that yearly boosters for certain specific diseases, such as distemper and parvovirus, are unproductive. It's not clear that it's harmful, but it's certainly not needed. I think that conventional veterinarians have been slow to give that up.\u003c/p>\n\u003cp>\u003cstrong>You've blogged about how there are a lot of misconceptions about the pros and cons of \u003c/strong>\u003ca href=\"http://skeptvet.com/Blog/2013/04/benefits-and-risks-of-neutering-an-evidence-based-approach/\">\u003cstrong>neutering a pet\u003c/strong>\u003c/a>\u003cstrong>. Where do people go wrong there?\u003c/strong>\u003c/p>\n\u003cp>I think the biggest misconception is that there is a simple, across-the-board, right answer to if and when you should neuter your pet. That's not the case, because biology is too complex for that. Broad rules such as \"every dog should be neutered at six months,\" or \"no pet should be neutered at all\" — none of those are justifiable because the answer is, frustratingly, \"It depends.\" It depends on the breed, on the age, on the particular balance of risks and benefits that you're talking about. The reality is that you should have a lengthy, nuanced discussion with your veterinarian about that.\u003c/p>\n\u003cp>\u003cstrong>Lots of pet owners will swear that their animals benefited from an alternative therapy, whether it's turmeric or \u003c/strong>\u003ca href=\"http://www.npr.org/sections/health-shots/2017/07/04/535060331/some-marijuana-derived-treatments-aim-to-soothe-skittish-pets\">\u003cstrong>cannabis-based extracts\u003c/strong>\u003c/a>\u003cstrong>. What's the trouble with relying on these anecdotes?\u003c/strong>\u003c/p>\n\u003cp>It's totally understandable why those kinds of experiences are compelling. But things that look to us like simple, straightforward relationships may not be. You know, the classic example is, every time I wash my car, it rains. We know that that is not a reasonable cause-and-effect relationship, because we understand how the weather works. But there were times in history when people believed that your personal actions could influence the weather.\u003c/p>\n\u003cp>Medicine is incredibly complex, and it is very difficult to identify a true response to a treatment simply by watching to see what happens, based only on our personal observations. Because there are so many factors involved in what happens next. And that's the reason why we have research studies that make an effort to control for sources of error. We know that science works better, because our own individual judgment and \u003ca href=\"http://skeptvet.com/Blog/2015/02/dont-believe-your-eyes-or-your-brain/\">observations are not reliable\u003c/a>.\u003c/p>\n\u003cp>\u003cstrong>What feedback do you get from readers?\u003c/strong>\u003c/p>\n\u003cp>With any controversial topic, I get a ton of \u003ca href=\"http://skeptvet.com/Blog/2015/05/skeptvet-gets-hate-mail-update-2015/\">hate mail\u003c/a>. A regular stream of \"How dare you — this worked for me and you're just awful\" or \"You're a tool of the pharmaceutical industry.\" But I also get a lot of people who write, \"Oh, thank God, finally, somebody is willing to ask questions or be critical of these things,\" because it's often so unpopular to do so.\u003c/p>\n\u003cp>\u003cstrong>Do you have pets?\u003c/strong>\u003c/p>\n\u003cp>I have two dogs: Max, a 10-year-old Boston terrier, and Brodie, a 4-year-old mutt from the shelter. And I have a 19-year-old corn snake named Tess. My wife, who is both afraid of snakes and a wonderfully supportive person, bought me a snake when I was in vet school because I wanted to learn more about exotic pets. I don't think she realized that corn snakes can live well into their 20s.\u003c/p>\n\u003cp>\u003cstrong>Have you ever tried a therapy for your pets that didn't have much scientific evidence behind it?\u003c/strong>\u003c/p>\n\u003cp>I previously had some dogs who were older and had arthritis, around when I first started practicing veterinary medicine. I put one of them on glucosamine because more experienced colleagues said it was helpful. I hadn't yet started looking at evidence-based medicine. I did not perceive any change in my dog, and overall, the scientific evidence of meaningful benefit from glucosamine is very weak.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But being a skeptic doesn't mean that I'm saying people should never use these kinds of things. There are definitely circumstances where trying something for which there is very little evidence is totally appropriate. I'm simply saying that pet owners need to be fully informed about the uncertainty and risks and benefits involved.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2017 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Pets+Deserve+Evidence-Based+Medicine%2C+Too%2C+Says+The+SkeptVet&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/435189/pets-deserve-evidence-based-medicine-too-says-the-skeptvet","authors":["byline_futureofyou_435189"],"categories":["futureofyou_1"],"tags":["futureofyou_972","futureofyou_1275","futureofyou_1192","futureofyou_1147","futureofyou_1351"],"collections":["futureofyou_1097"],"featImg":"futureofyou_435190","label":"futureofyou_1097"},"futureofyou_338935":{"type":"posts","id":"futureofyou_338935","meta":{"index":"posts_1591205157","site":"futureofyou","id":"338935","score":null,"sort":[1487961866000]},"guestAuthors":[],"slug":"hundreds-of-babies-reported-harmed-by-homeopathic-product","title":"Hundreds of Babies Reported Harmed by Homeopathic Product","publishDate":1487961866,"format":"aside","headTitle":"KQED Future of You | KQED Science","labelTerm":{},"content":"\u003cp>Case 7682299: Aug. 1, 2010. A mother gives her toddler three homeopathic pills to relieve her teething pain. Within minutes, the baby stops breathing.\u003c/p>\n\u003cp>“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets,” the mother later told the Food and Drug Administration. “She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”\u003c/p>\n\u003cp>The company, \u003ca href=\"https://www.hylands.com/\" target=\"_blank\">Hyland’s\u003c/a>, promotes “safe, effective, and natural health solutions” that appeal to parents seeking alternative treatments. But the agency would soon hear much more about Hyland’s teething products. Staff at the FDA would come to consider Case 7682299 one of the luckier outcomes.\u003c/p>\n\u003cfigure id=\"attachment_341968\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-341968 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/02/homeopathic-800x800.jpg\" alt=\"A review of FDA records shows that some babies who were given Hyland’s teething products had repeated seizures, became delirious or turned blue and died. \" width=\"800\" height=\"800\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-800x800.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-160x160.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-768x768.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-1020x1020.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-1180x1180.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-960x960.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-240x240.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-375x375.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-520x520.jpg 520w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-50x50.jpg 50w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-150x150.jpg 150w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic.jpg 1600w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">A review of FDA records shows that some babies who were given Hyland’s teething products had repeated seizures, became delirious or turned blue and died. \u003ccite>(Photo from FDA)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>A review of FDA records obtained by STAT under the Freedom of Information Act paints a far grimmer picture: Babies who were given Hyland’s teething products turned blue and died. Babies had repeated seizures. Babies became delirious. Babies were airlifted to the hospital, where emergency room staff tried to figure out what had caused their legs and arms to start twitching.\u003cstrong> \u003c/strong>\u003c/p>\n\u003cp>Over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel, a similar product that is applied directly to a baby’s gums. Agency records show eight cases in which babies were reported to have died after taking Hyland’s products, though the FDA says the question of whether those products caused the deaths is still under review.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>(The agency is also investigating two other deaths tied to teething remedies but declined to confirm the manufacturer of the products or provide the case reports.)\u003c/p>\n\u003cp>Following an \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm\" target=\"_blank\">FDA warning in September\u003c/a>, Hyland’s said that it \u003ca href=\"https://www.hylands.com/hylands-discontinues-teething-tablets-and-gels\" target=\"_blank\">would no longer manufacture\u003c/a> the teething products. But they remained on some store shelves for months, and are still available on the internet. They likely continue to be used in homes nationwide.\u003c/p>\n\u003cp>Hyland’s, a 114-year-old private company based in Los Angeles, is the nation’s largest homeopathic business. It insists its products are safe and says the FDA has failed to show there is a scientific link between them and infant seizures or other complications.\u003c/p>\n\u003cp>“That doesn’t mean that children don’t have a sensitivity to a product. There is a lot of sensitivity on kids’ parts and we have to watch carefully,” said a spokeswoman, Mary Borneman. “It’s not something that condemns the entire product line.”\u003c/p>\n\u003cp>Behind each of the FDA case numbers are angry and, in some cases, heartbroken parents. But a STAT examination — and the first detailed look at the case reports — also raises questions over the response of regulators.\u003c/p>\n\u003cp>It took four years until the FDA pushed Hyland’s to reformulate its remedies, in 2010. In the seven years since then, there has been a steady stream of reports of adverse events tied to Hyland’s homeopathic teething products.\u003c/p>\n\u003cp>“The FDA could bring the hammer down on them,” said Sarah Sorscher, an attorney for the nonprofit Public Citizen Health Research Group. “But it doesn’t. At the point where you have infants being hospitalized and deaths reported, it’s simply not acceptable for the agency to delay in taking action.”\u003c/p>\n\u003cp>An FDA spokeswoman defended the agency’s handling of the matter.\u003c/p>\n\u003cp>“It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product,” the spokeswoman, Lyndsay Meyer, said in a statement.\u003c/p>\n\u003cp>Despite the FDA’s difficulty in proving Hyland’s products harmed children, some doctors had no doubt.\u003c/p>\n\u003cp>In case 462749, dated Sept. 15, 2011, a physician sent Hyland’s a handwritten note, stating his patient, a 5-month-old girl, was unresponsive for 45 minutes after taking its teething tablets.\u003c/p>\n\u003cp>“I am sure this was not an allergic reaction,” he wrote. “I would like you to report it, find a contact at the FDA, so we can start an investigation and pull this dangerous, unregulated product from the shelves.”\u003c/p>\n\u003cp>One mother wrote the company to say her son’s pupils dilated “like marbles with big black eyes.” Another described seizures her daughter continued to have after taking the tablets and told the company, “I hate hate hate u for this.”\u003c/p>\n\u003cfigure id=\"attachment_342003\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-342003 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/02/homeophathadverse-800x450.jpg\" alt=\"homeophathadverse\" width=\"800\" height=\"450\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-800x450.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-160x90.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-768x432.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-1020x574.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-1180x664.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-960x540.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-240x135.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-375x211.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-520x293.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Adverse event report on Hyland' teething tablets, sent to FDA. \u003ccite>(Photo by STAT)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>An Industry Giant in a Giant Industry\u003c/strong>\u003c/p>\n\u003cp>Hyland’s and its parent company, Standard Homeopathy Co., are considered major players in the homeopathic market. CEO \u003ca href=\"https://www.hylands.com/meet-the-team/jay-borneman\" target=\"_blank\">John P. Borneman\u003c/a> comes from a family that has been in the business for generations, and is president of the industry group that publishes the Homeopathic Pharmacopeia, a compendium that serves as the bible of the industry.\u003c/p>\n\u003cp>The company sells dozens of products for pain relief, stress, sleep problems, allergies, flu, and other maladies.\u003c/p>\n\u003cp>As with all homeopathic treatments, Hyland’s products are based on a theory that patients can benefit from highly diluted natural substances that, in their original form, might make people sick.\u003c/p>\n\u003cp>Despite a lack of scientific evidence that homeopathic remedies work, they are ubiquitous.\u003c/p>\n\u003cp>Homeopathy has become a multibillion-dollar industry. Its products are big sellers around the world, and popular with adherents from Cher to Prince Charles. The industry also has political clout: It has been able to exempt itself from many rules proposed by Congress and the FDA over the years.\u003c/p>\n\u003cp>Unlike pharmaceutical company-produced drugs, homeopathic products don’t have to prove that they are effective at treating anything in particular before going on the market. It is left to the FDA’s drug division to determine whether they are unsafe after they are on the market — a difficult task since the adverse event reports are generally considered to represent only a fraction of the actual incidents and may lack sufficient information to allow for thorough investigations.\u003c/p>\n\u003cp>“If I’m working in the emergency room and I have a family that comes in with a seizing infant, I may not have the wherewithal to get the history of homeopathic use,” said Dr. Edward W. Boyer, a toxicologist in Harvard Medical School’s emergency medicine department.\u003c/p>\n\u003cp>In some cases, parents assume that products described as natural remedies, as is the case with Hyland’s tablets and gels, could not possibly result in complications, and never mention their use to a doctor. Without sufficient evidence of a problem, the FDA lacks what it needs to use the enforcement tools it does have.\u003c/p>\n\u003cp>For Karinna Talbott, a 26-year-old mother in Colorado Springs, the fact that Hyland’s teething products were labeled “natural” made her lower her guard.\u003c/p>\n\u003cp>“When our fourth kiddo comes around and starts teething at three months, we were like, ‘OK, what can we do to give him some relief?’” Talbott said. “Someone told us about the teething tablets and we thought, ‘give them a try.' ’’\u003c/p>\n\u003cp>Shortly after her son began taking the tablets, she said, his hands began twitching.\u003c/p>\n\u003cp>“We didn’t correlate it to the teething tablets,” Talbott said. “And his symptoms got worse, went to his arms and his feet. Sometimes they all happened together.”\u003c/p>\n\u003cp>Talbott said her doctor was at first uncertain as to the cause. But when they stopped giving him the tablets, the seizures also stopped.\u003c/p>\n\u003cp>“The neurologist said, maybe he was a little sensitive to the products in the teething tablet.”\u003c/p>\n\u003cp>\u003cstrong>‘Deadly nightshade’\u003c/strong>\u003c/p>\n\u003cp>In investigating Hyland’s teething products, the FDA focused on an ingredient known as atropa belladonna, an herb known colloquially as “deadly nightshade.”\u003c/p>\n\u003cp>In diluted form, the substance is not expected to pose any health risk. In 2010, however, FDA inspectors who examined Hyland’s facilities criticized the company for substandard manufacturing practices and found inconsistent levels of atropa belladonna in its products.\u003c/p>\n\u003cp>The agency issued a public warning, noting “reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.”\u003c/p>\n\u003cp>It also noted that “infants are very susceptible to the neurotoxicity of drugs” because of how the body distributes and responds to drugs, and noted that “absorption of belladonna from the skin and mouth was fairly rapid.”\u003c/p>\n\u003cp>The company voluntarily took the products off shelves and agreed to reformulate them, although it insisted they were safe.\u003c/p>\n\u003cp>“We felt it was the right thing to do so that parents didn’t have to be concerned about the product,” said Borneman, the spokeswoman.\u003c/p>\n\u003cp>But the number of serious adverse events tied by the FDA to the products kept climbing. Some pediatricians and neurologists concluded the tablets and gels were the cause. Many parents wrote to the FDA, accusingly, asking why the pills were still on the market.\u003c/p>\n\u003cp>“My son had 3 of Hyland’s Teething Tablets,” a mother told FDA on Feb. 13, 2012, noting that the product appeared to have caused several seizures. “I am shocked at the popularity of this product, which is growing, and the lack of knowledge among parents, as well as the lack of warnings on the labels. Parents desperately need to be warned about this product if it is going to stay on the shelves!!!! Please do something!”\u003c/p>\n\u003cp>In September 2016, the \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm\" target=\"_blank\">FDA announced\u003c/a> that it was investigating more adverse events reports and recommended that consumers stop using Hyland’s and other homeopathic teething products and dispose of any in their possession. Some stores, including Target and CVS, which sold Hyland’s and other homeopathic teething products, pulled them in response.\u003c/p>\n\u003cp>The FDA also asked Hyland’s to recall its products again. But this time Hyland’s stood its ground, and the agency has no authority to enforce a recall of homeopathic products.\u003c/p>\n\u003cp>Borneman said the company’s “pharmacovigilance program,” a product safety review system launched after 2010, offers proof that the treatments are safe.\u003c/p>\n\u003cp>“Homeopathic medicine has a very large margin of safety,” she said. “Our testing ensures there’s not too much belladonna in any bottle” of tablets.\u003c/p>\n\u003cp>At the same time, the company decided to stop manufacturing the teething tablets. In an \u003ca href=\"https://www.hylands.com/hylands-discontinues-teething-tablets-and-gels\" target=\"_blank\">open letter to customers\u003c/a>, Hyland’s said the FDA warning had “created confusion among parents.”\u003c/p>\n\u003cp>“Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA,” the company said, while insisting Hyland’s products, “including those you already have, are safe for use.”\u003c/p>\n\u003cp>Several weeks ago, on Jan. 27, the FDA \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm\" target=\"_blank\">issued another warning\u003c/a>, saying that laboratory analysis of Hyland’s teething tablets found levels of belladonna “sometimes far exceeding the amount claimed on the label.” The agency warned consumers not to use the products and to seek medical care immediately if their child has seizures, difficulty breathing, lethargy, muscle weakness, or other problems after using homeopathic teething products.\u003c/p>\n\u003cp>The FDA also said there was no evidence that they actually worked.\u003c/p>\n\u003cfigure id=\"attachment_342006\" class=\"wp-caption aligncenter\" style=\"max-width: 768px\">\u003cimg class=\"wp-image-342006 size-full\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/02/homeopathicevent.jpg\" alt=\"homeopathicevent\" width=\"768\" height=\"432\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-160x90.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-240x135.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-375x211.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-520x293.jpg 520w\" sizes=\"(max-width: 768px) 100vw, 768px\">\u003cfigcaption class=\"wp-caption-text\">Report sent to FDA by a physician. \u003ccite>(Photo by STAT)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Cracks in the FDA’s Authority\u003c/strong>\u003c/p>\n\u003cp>With concerns about toxic levels of belladonna, and the sheer number of cases of adverse events, some critics — and parents — say the FDA should have moved faster in the case of Hyland’s.\u003c/p>\n\u003cp>But they also acknowledge that the episode underlines the cracks in the agency’s regulatory power when it comes to homeopathic products. There is no set mathematical formula or official standard that spells out how many sick or deceased children must be reported before the FDA seizes a company’s inventory or levies fines or shuts it down.\u003c/p>\n\u003cp>Critics say the fact that homeopathic products are generally highly diluted has kept them on the FDA’s back burner.\u003c/p>\n\u003cp>“It’s low on their priority list,” said Dr. Aaron S. Kesselheim, who \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMp1513393#t=article\" target=\"_blank\">coauthored a paper\u003c/a> in the New England Journal of Medicine last year on the subject. “FDA for a long time just kind of deferred on homeopathic products because they are mostly inert and so diluted. The harm comes from people wasting their money, or diverting them from things that do work.”\u003c/p>\n\u003cp>In the case of some of Hyland’s products, however, Kesselheim believes that the toxic levels of belladonna show a substantial safety problem, putting a responsibility on FDA to respond.\u003c/p>\n\u003cp>One problem the FDA has in doing so is a matter of staffing: The agency has a medical officer review each report from manufacturers, but it doesn’t have someone who can routinely follow up with the patient, the patient’s family, or physician for missing records necessary to take a serious enforcement action.\u003c/p>\n\u003cp>“Is it fair to criticize FDA for the time lag between 2010 and now?” says Patricia Zettler, a former FDA counsel and associate law professor at Georgia State University. “I think the agency is in a tough position, with these kinds of products and with adverse event reports in general. They are not necessarily a perfect indication of something happening with a drug.”\u003c/p>\n\u003cp>“That said,” Zettler added, “it does sound like this is a product the agency was concerned about. It’s tough to parse out whether two reports of seizures should have been enough, or three or 10. There’s a balance the agency has to strike between acting quickly on safety information and not overreacting to something that may not actually be caused by the product.”\u003c/p>\n\u003cp>Public Citizen’s Sorscher said criminal cases take years to pursue, so the FDA would much prefer voluntary compliance.\u003c/p>\n\u003cp>“They don’t have a mechanism to say, ‘this ingredient is unsafe, nobody should sell it,’” she said. “It might be time for Congress to give FDA a standard and say, you can issue a regulation saying no one can make it anymore.”\u003c/p>\n\u003cp>Outraged by the standoff between FDA and Hyland’s, Connecticut Democratic Representative Rosa DeLauro \u003ca href=\"https://delauro.house.gov/media-center/press-releases/delauro-introduces-bill-give-fda-mandatory-recall-authority-over-drugs\" target=\"_blank\">introduced a bill last week\u003c/a> called the Recall Unsafe Drugs Act. The proposal would give the FDA mandatory recall authority over homeopathic products and drugs.\u003c/p>\n\u003cp>“Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is downright shameful,” DeLauro said, adding that the company “is choosing instead to prioritize the company’s profits and reputation before the safety of our children.”\u003c/p>\n\u003cp>“As it stands the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families.’’\u003c/p>\n\u003cp>For the parents of Case 10723317, any action would come too late. A mother reported that on July 9, 2014, her 9-month-old daughter died after being given two teething tablets, crushed, for the first time. She gave her infant the tablets, then a bottle, and then left her to sleep. When she checked on her 45 minutes later, she was dead in her crib, beside a puddle of vomit.\u003c/p>\n\u003cp>Five months later, after reading online reports suggesting babies may experience seizures after taking belladonna, she contacted Hyland’s.\u003c/p>\n\u003cp>“Customer did not request a refund or replacement,” noted the Hyland’s staffer who filed the report with the FDA. Hyland’s also noted that it was not able to test the bottle, because the customer threw it away.\u003c/p>\n\u003cp>“Due to the limited information provided by the reporter no further investigation is possible at this time of this incident,” the company concluded.\u003c/p>\n\u003cp>\u003cem>Ike Swetlitz contributed reporting.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2017/02/21/hylands-homeopathic-teething-fda/\" target=\"_blank\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"The FDA has collected reports of 'adverse events' in over 370 children who used Hyland’s homeopathic teething products, and the agency is investigating whether the products caused the deaths of eight babies. ","status":"publish","parent":0,"modified":1488214874,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":72,"wordCount":2799},"headData":{"title":"Hundreds of Babies Reported Harmed by Homeopathic Product | KQED","description":"The FDA has collected reports of 'adverse events' in over 370 children who used Hyland’s homeopathic teething products, and the agency is investigating whether the products caused the deaths of eight babies. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Hundreds of Babies Reported Harmed by Homeopathic Product","datePublished":"2017-02-24T18:44:26.000Z","dateModified":"2017-02-27T17:01:14.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"338935 https://ww2.kqed.org/futureofyou/?p=338935","disqusUrl":"https://ww2.kqed.org/futureofyou/2017/02/24/hundreds-of-babies-reported-harmed-by-homeopathic-product/","disqusTitle":"Hundreds of Babies Reported Harmed by Homeopathic Product","source":"STAT","nprByline":"Sheila Kaplan\u003cbr />\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>","path":"/futureofyou/338935/hundreds-of-babies-reported-harmed-by-homeopathic-product","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Case 7682299: Aug. 1, 2010. A mother gives her toddler three homeopathic pills to relieve her teething pain. Within minutes, the baby stops breathing.\u003c/p>\n\u003cp>“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets,” the mother later told the Food and Drug Administration. “She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”\u003c/p>\n\u003cp>The company, \u003ca href=\"https://www.hylands.com/\" target=\"_blank\">Hyland’s\u003c/a>, promotes “safe, effective, and natural health solutions” that appeal to parents seeking alternative treatments. But the agency would soon hear much more about Hyland’s teething products. Staff at the FDA would come to consider Case 7682299 one of the luckier outcomes.\u003c/p>\n\u003cfigure id=\"attachment_341968\" class=\"wp-caption alignright\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-341968 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/02/homeopathic-800x800.jpg\" alt=\"A review of FDA records shows that some babies who were given Hyland’s teething products had repeated seizures, became delirious or turned blue and died. \" width=\"800\" height=\"800\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-800x800.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-160x160.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-768x768.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-1020x1020.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-1180x1180.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-960x960.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-240x240.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-375x375.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-520x520.jpg 520w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-32x32.jpg 32w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-50x50.jpg 50w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-64x64.jpg 64w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-96x96.jpg 96w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-128x128.jpg 128w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic-150x150.jpg 150w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathic.jpg 1600w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">A review of FDA records shows that some babies who were given Hyland’s teething products had repeated seizures, became delirious or turned blue and died. \u003ccite>(Photo from FDA)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>A review of FDA records obtained by STAT under the Freedom of Information Act paints a far grimmer picture: Babies who were given Hyland’s teething products turned blue and died. Babies had repeated seizures. Babies became delirious. Babies were airlifted to the hospital, where emergency room staff tried to figure out what had caused their legs and arms to start twitching.\u003cstrong> \u003c/strong>\u003c/p>\n\u003cp>Over a 10-year period, from 2006 to 2016, the FDA collected reports of “adverse events” in more than 370 children who had used Hyland’s homeopathic teething tablets or gel, a similar product that is applied directly to a baby’s gums. Agency records show eight cases in which babies were reported to have died after taking Hyland’s products, though the FDA says the question of whether those products caused the deaths is still under review.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>(The agency is also investigating two other deaths tied to teething remedies but declined to confirm the manufacturer of the products or provide the case reports.)\u003c/p>\n\u003cp>Following an \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm\" target=\"_blank\">FDA warning in September\u003c/a>, Hyland’s said that it \u003ca href=\"https://www.hylands.com/hylands-discontinues-teething-tablets-and-gels\" target=\"_blank\">would no longer manufacture\u003c/a> the teething products. But they remained on some store shelves for months, and are still available on the internet. They likely continue to be used in homes nationwide.\u003c/p>\n\u003cp>Hyland’s, a 114-year-old private company based in Los Angeles, is the nation’s largest homeopathic business. It insists its products are safe and says the FDA has failed to show there is a scientific link between them and infant seizures or other complications.\u003c/p>\n\u003cp>“That doesn’t mean that children don’t have a sensitivity to a product. There is a lot of sensitivity on kids’ parts and we have to watch carefully,” said a spokeswoman, Mary Borneman. “It’s not something that condemns the entire product line.”\u003c/p>\n\u003cp>Behind each of the FDA case numbers are angry and, in some cases, heartbroken parents. But a STAT examination — and the first detailed look at the case reports — also raises questions over the response of regulators.\u003c/p>\n\u003cp>It took four years until the FDA pushed Hyland’s to reformulate its remedies, in 2010. In the seven years since then, there has been a steady stream of reports of adverse events tied to Hyland’s homeopathic teething products.\u003c/p>\n\u003cp>“The FDA could bring the hammer down on them,” said Sarah Sorscher, an attorney for the nonprofit Public Citizen Health Research Group. “But it doesn’t. At the point where you have infants being hospitalized and deaths reported, it’s simply not acceptable for the agency to delay in taking action.”\u003c/p>\n\u003cp>An FDA spokeswoman defended the agency’s handling of the matter.\u003c/p>\n\u003cp>“It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product,” the spokeswoman, Lyndsay Meyer, said in a statement.\u003c/p>\n\u003cp>Despite the FDA’s difficulty in proving Hyland’s products harmed children, some doctors had no doubt.\u003c/p>\n\u003cp>In case 462749, dated Sept. 15, 2011, a physician sent Hyland’s a handwritten note, stating his patient, a 5-month-old girl, was unresponsive for 45 minutes after taking its teething tablets.\u003c/p>\n\u003cp>“I am sure this was not an allergic reaction,” he wrote. “I would like you to report it, find a contact at the FDA, so we can start an investigation and pull this dangerous, unregulated product from the shelves.”\u003c/p>\n\u003cp>One mother wrote the company to say her son’s pupils dilated “like marbles with big black eyes.” Another described seizures her daughter continued to have after taking the tablets and told the company, “I hate hate hate u for this.”\u003c/p>\n\u003cfigure id=\"attachment_342003\" class=\"wp-caption aligncenter\" style=\"max-width: 800px\">\u003cimg class=\"wp-image-342003 size-medium\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/02/homeophathadverse-800x450.jpg\" alt=\"homeophathadverse\" width=\"800\" height=\"450\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-800x450.jpg 800w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-160x90.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-768x432.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-1020x574.jpg 1020w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse.jpg 1920w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-1180x664.jpg 1180w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-960x540.jpg 960w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-240x135.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-375x211.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeophathadverse-520x293.jpg 520w\" sizes=\"(max-width: 800px) 100vw, 800px\">\u003cfigcaption class=\"wp-caption-text\">Adverse event report on Hyland' teething tablets, sent to FDA. \u003ccite>(Photo by STAT)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>An Industry Giant in a Giant Industry\u003c/strong>\u003c/p>\n\u003cp>Hyland’s and its parent company, Standard Homeopathy Co., are considered major players in the homeopathic market. CEO \u003ca href=\"https://www.hylands.com/meet-the-team/jay-borneman\" target=\"_blank\">John P. Borneman\u003c/a> comes from a family that has been in the business for generations, and is president of the industry group that publishes the Homeopathic Pharmacopeia, a compendium that serves as the bible of the industry.\u003c/p>\n\u003cp>The company sells dozens of products for pain relief, stress, sleep problems, allergies, flu, and other maladies.\u003c/p>\n\u003cp>As with all homeopathic treatments, Hyland’s products are based on a theory that patients can benefit from highly diluted natural substances that, in their original form, might make people sick.\u003c/p>\n\u003cp>Despite a lack of scientific evidence that homeopathic remedies work, they are ubiquitous.\u003c/p>\n\u003cp>Homeopathy has become a multibillion-dollar industry. Its products are big sellers around the world, and popular with adherents from Cher to Prince Charles. The industry also has political clout: It has been able to exempt itself from many rules proposed by Congress and the FDA over the years.\u003c/p>\n\u003cp>Unlike pharmaceutical company-produced drugs, homeopathic products don’t have to prove that they are effective at treating anything in particular before going on the market. It is left to the FDA’s drug division to determine whether they are unsafe after they are on the market — a difficult task since the adverse event reports are generally considered to represent only a fraction of the actual incidents and may lack sufficient information to allow for thorough investigations.\u003c/p>\n\u003cp>“If I’m working in the emergency room and I have a family that comes in with a seizing infant, I may not have the wherewithal to get the history of homeopathic use,” said Dr. Edward W. Boyer, a toxicologist in Harvard Medical School’s emergency medicine department.\u003c/p>\n\u003cp>In some cases, parents assume that products described as natural remedies, as is the case with Hyland’s tablets and gels, could not possibly result in complications, and never mention their use to a doctor. Without sufficient evidence of a problem, the FDA lacks what it needs to use the enforcement tools it does have.\u003c/p>\n\u003cp>For Karinna Talbott, a 26-year-old mother in Colorado Springs, the fact that Hyland’s teething products were labeled “natural” made her lower her guard.\u003c/p>\n\u003cp>“When our fourth kiddo comes around and starts teething at three months, we were like, ‘OK, what can we do to give him some relief?’” Talbott said. “Someone told us about the teething tablets and we thought, ‘give them a try.' ’’\u003c/p>\n\u003cp>Shortly after her son began taking the tablets, she said, his hands began twitching.\u003c/p>\n\u003cp>“We didn’t correlate it to the teething tablets,” Talbott said. “And his symptoms got worse, went to his arms and his feet. Sometimes they all happened together.”\u003c/p>\n\u003cp>Talbott said her doctor was at first uncertain as to the cause. But when they stopped giving him the tablets, the seizures also stopped.\u003c/p>\n\u003cp>“The neurologist said, maybe he was a little sensitive to the products in the teething tablet.”\u003c/p>\n\u003cp>\u003cstrong>‘Deadly nightshade’\u003c/strong>\u003c/p>\n\u003cp>In investigating Hyland’s teething products, the FDA focused on an ingredient known as atropa belladonna, an herb known colloquially as “deadly nightshade.”\u003c/p>\n\u003cp>In diluted form, the substance is not expected to pose any health risk. In 2010, however, FDA inspectors who examined Hyland’s facilities criticized the company for substandard manufacturing practices and found inconsistent levels of atropa belladonna in its products.\u003c/p>\n\u003cp>The agency issued a public warning, noting “reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.”\u003c/p>\n\u003cp>It also noted that “infants are very susceptible to the neurotoxicity of drugs” because of how the body distributes and responds to drugs, and noted that “absorption of belladonna from the skin and mouth was fairly rapid.”\u003c/p>\n\u003cp>The company voluntarily took the products off shelves and agreed to reformulate them, although it insisted they were safe.\u003c/p>\n\u003cp>“We felt it was the right thing to do so that parents didn’t have to be concerned about the product,” said Borneman, the spokeswoman.\u003c/p>\n\u003cp>But the number of serious adverse events tied by the FDA to the products kept climbing. Some pediatricians and neurologists concluded the tablets and gels were the cause. Many parents wrote to the FDA, accusingly, asking why the pills were still on the market.\u003c/p>\n\u003cp>“My son had 3 of Hyland’s Teething Tablets,” a mother told FDA on Feb. 13, 2012, noting that the product appeared to have caused several seizures. “I am shocked at the popularity of this product, which is growing, and the lack of knowledge among parents, as well as the lack of warnings on the labels. Parents desperately need to be warned about this product if it is going to stay on the shelves!!!! Please do something!”\u003c/p>\n\u003cp>In September 2016, the \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm\" target=\"_blank\">FDA announced\u003c/a> that it was investigating more adverse events reports and recommended that consumers stop using Hyland’s and other homeopathic teething products and dispose of any in their possession. Some stores, including Target and CVS, which sold Hyland’s and other homeopathic teething products, pulled them in response.\u003c/p>\n\u003cp>The FDA also asked Hyland’s to recall its products again. But this time Hyland’s stood its ground, and the agency has no authority to enforce a recall of homeopathic products.\u003c/p>\n\u003cp>Borneman said the company’s “pharmacovigilance program,” a product safety review system launched after 2010, offers proof that the treatments are safe.\u003c/p>\n\u003cp>“Homeopathic medicine has a very large margin of safety,” she said. “Our testing ensures there’s not too much belladonna in any bottle” of tablets.\u003c/p>\n\u003cp>At the same time, the company decided to stop manufacturing the teething tablets. In an \u003ca href=\"https://www.hylands.com/hylands-discontinues-teething-tablets-and-gels\" target=\"_blank\">open letter to customers\u003c/a>, Hyland’s said the FDA warning had “created confusion among parents.”\u003c/p>\n\u003cp>“Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA,” the company said, while insisting Hyland’s products, “including those you already have, are safe for use.”\u003c/p>\n\u003cp>Several weeks ago, on Jan. 27, the FDA \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm\" target=\"_blank\">issued another warning\u003c/a>, saying that laboratory analysis of Hyland’s teething tablets found levels of belladonna “sometimes far exceeding the amount claimed on the label.” The agency warned consumers not to use the products and to seek medical care immediately if their child has seizures, difficulty breathing, lethargy, muscle weakness, or other problems after using homeopathic teething products.\u003c/p>\n\u003cp>The FDA also said there was no evidence that they actually worked.\u003c/p>\n\u003cfigure id=\"attachment_342006\" class=\"wp-caption aligncenter\" style=\"max-width: 768px\">\u003cimg class=\"wp-image-342006 size-full\" src=\"https://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2017/02/homeopathicevent.jpg\" alt=\"homeopathicevent\" width=\"768\" height=\"432\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent.jpg 768w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-160x90.jpg 160w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-240x135.jpg 240w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-375x211.jpg 375w, https://ww2.kqed.org/app/uploads/sites/13/2017/02/homeopathicevent-520x293.jpg 520w\" sizes=\"(max-width: 768px) 100vw, 768px\">\u003cfigcaption class=\"wp-caption-text\">Report sent to FDA by a physician. \u003ccite>(Photo by STAT)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>\u003cstrong>Cracks in the FDA’s Authority\u003c/strong>\u003c/p>\n\u003cp>With concerns about toxic levels of belladonna, and the sheer number of cases of adverse events, some critics — and parents — say the FDA should have moved faster in the case of Hyland’s.\u003c/p>\n\u003cp>But they also acknowledge that the episode underlines the cracks in the agency’s regulatory power when it comes to homeopathic products. There is no set mathematical formula or official standard that spells out how many sick or deceased children must be reported before the FDA seizes a company’s inventory or levies fines or shuts it down.\u003c/p>\n\u003cp>Critics say the fact that homeopathic products are generally highly diluted has kept them on the FDA’s back burner.\u003c/p>\n\u003cp>“It’s low on their priority list,” said Dr. Aaron S. Kesselheim, who \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMp1513393#t=article\" target=\"_blank\">coauthored a paper\u003c/a> in the New England Journal of Medicine last year on the subject. “FDA for a long time just kind of deferred on homeopathic products because they are mostly inert and so diluted. The harm comes from people wasting their money, or diverting them from things that do work.”\u003c/p>\n\u003cp>In the case of some of Hyland’s products, however, Kesselheim believes that the toxic levels of belladonna show a substantial safety problem, putting a responsibility on FDA to respond.\u003c/p>\n\u003cp>One problem the FDA has in doing so is a matter of staffing: The agency has a medical officer review each report from manufacturers, but it doesn’t have someone who can routinely follow up with the patient, the patient’s family, or physician for missing records necessary to take a serious enforcement action.\u003c/p>\n\u003cp>“Is it fair to criticize FDA for the time lag between 2010 and now?” says Patricia Zettler, a former FDA counsel and associate law professor at Georgia State University. “I think the agency is in a tough position, with these kinds of products and with adverse event reports in general. They are not necessarily a perfect indication of something happening with a drug.”\u003c/p>\n\u003cp>“That said,” Zettler added, “it does sound like this is a product the agency was concerned about. It’s tough to parse out whether two reports of seizures should have been enough, or three or 10. There’s a balance the agency has to strike between acting quickly on safety information and not overreacting to something that may not actually be caused by the product.”\u003c/p>\n\u003cp>Public Citizen’s Sorscher said criminal cases take years to pursue, so the FDA would much prefer voluntary compliance.\u003c/p>\n\u003cp>“They don’t have a mechanism to say, ‘this ingredient is unsafe, nobody should sell it,’” she said. “It might be time for Congress to give FDA a standard and say, you can issue a regulation saying no one can make it anymore.”\u003c/p>\n\u003cp>Outraged by the standoff between FDA and Hyland’s, Connecticut Democratic Representative Rosa DeLauro \u003ca href=\"https://delauro.house.gov/media-center/press-releases/delauro-introduces-bill-give-fda-mandatory-recall-authority-over-drugs\" target=\"_blank\">introduced a bill last week\u003c/a> called the Recall Unsafe Drugs Act. The proposal would give the FDA mandatory recall authority over homeopathic products and drugs.\u003c/p>\n\u003cp>“Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is downright shameful,” DeLauro said, adding that the company “is choosing instead to prioritize the company’s profits and reputation before the safety of our children.”\u003c/p>\n\u003cp>“As it stands the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families.’’\u003c/p>\n\u003cp>For the parents of Case 10723317, any action would come too late. A mother reported that on July 9, 2014, her 9-month-old daughter died after being given two teething tablets, crushed, for the first time. She gave her infant the tablets, then a bottle, and then left her to sleep. When she checked on her 45 minutes later, she was dead in her crib, beside a puddle of vomit.\u003c/p>\n\u003cp>Five months later, after reading online reports suggesting babies may experience seizures after taking belladonna, she contacted Hyland’s.\u003c/p>\n\u003cp>“Customer did not request a refund or replacement,” noted the Hyland’s staffer who filed the report with the FDA. Hyland’s also noted that it was not able to test the bottle, because the customer threw it away.\u003c/p>\n\u003cp>“Due to the limited information provided by the reporter no further investigation is possible at this time of this incident,” the company concluded.\u003c/p>\n\u003cp>\u003cem>Ike Swetlitz contributed reporting.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This \u003ca href=\"https://www.statnews.com/2017/02/21/hylands-homeopathic-teething-fda/\" target=\"_blank\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/338935/hundreds-of-babies-reported-harmed-by-homeopathic-product","authors":["byline_futureofyou_338935"],"categories":["futureofyou_452","futureofyou_1062","futureofyou_1","futureofyou_73"],"tags":["futureofyou_972","futureofyou_1193","futureofyou_38","futureofyou_1192","futureofyou_1191"],"featImg":"futureofyou_341968","label":"source_futureofyou_338935"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. 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You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED MindShift: How We Will Learn","officialWebsiteLink":"/mindshift/","meta":{"site":"news","source":"kqed","order":"2"},"link":"/podcasts/mindshift","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/mindshift-podcast/id1078765985","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5","npr":"https://www.npr.org/podcasts/464615685/mind-shift-podcast","stitcher":"https://www.stitcher.com/podcast/kqed/stories-teachers-share","spotify":"https://open.spotify.com/show/0MxSpNYZKNprFLCl7eEtyx"}},"morning-edition":{"id":"morning-edition","title":"Morning Edition","info":"\u003cem>Morning Edition\u003c/em> takes listeners around the country and the world with multi-faceted stories and commentaries every weekday. 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