"Let food be thy medicine and medicine be thy food." --Hippocrates
The sage advice of "the father of medicine" for centuries, has evolved into the adage "You are what you eat." By now, we all know if your diet includes four bowls of ice cream, two Porterhouse steaks and a six pack every day, you are likely to suffer from obesity, alcoholism and an occasional heart attack. We also know damn well that we should mind our mothers who urge us to "eat your vegetables". Mankind has learned from centuries of consuming food what works to sustain us and scientific analysis has long served to enhance this "common" knowledge with a vast universe of precise information about what is in our food and how it affects our health.
Our newest merger of food and health interests has created a new dietary love affair-- supplements. Dietary supplements (minerals, botanicals, herbs. minerals, amino acids, concentrates and extracts) have evolved into a new and controversial way to enhance nutritional value. I seek to shed some light on the size of the industry and how to determine if the supplements lining the shelves of your local pharmacy, grocery store, convenience store or website warehouse are safe to consume. (The industry is vast and complicated, so I will publish another blog next week to address the efficacy of various products by providing governmental and private websites which are well respected for providing objective information about supplements as well as answering questions about healthy lifestyles, many diseases and how our amazing human bodies function.)
Size: This industry is tricky to size because there are oodles of privately held companies, endless supply chains, and fuzzy product descriptions. Detailed reports can cost thousands, so I relied on official US governmental agencies such as the Food and Drug Administration and The National Institute of Health as well as respected journals like Nature or magazines such as Consumer Reports. The last reliable numbers show that in 2006 over half of adults used supplements (usage in 1988-1994 hovered around 24 per cent.) In 2000, $17.2 billion in profits was reported; in 2017--$36.1 billion. The boomer generation grew up when the industry was virtually nonexistent. Many of them had chuckled when people began taking pills for nutrition or weight loss. They thought it was just a craze; now at least half of adults 65 and older take daily vitamins and supplements.
Safety: People should note that the Food Drug Administration does not regulate supplements the same way as prescription medications involving years of tightly controlled clinical trials. The FDA's role is primarily to investigate supplements which reveal a potential for harm to users and to enforce the FDA's Good Manufacturing Practices which technically ensures production standards and licensing. Sounds good, but in reality, Consumer Reports reported in 2015 there were 15,000 supplement manufacturers in the US in 2015 and since 2010 the agency has inspected less than 400 of those companies per fiscal year. To remove a supplement from the market, the FDA must show that it poses a danger to consumers once it is already for sale. depending on reports from doctors, consumers and supplement manufacturers to report any issues. But even doctors might not connect the dots between an illness and the use of a supplement by a patient and call the FDA. The Government Accountability Office found that 5,000 more supplement related calls were going to poison control offices than to the FDA in 2015. The Sept. 2016 Consumer Reports magazine reported 23,000 people per year are treated at the ER after taking a supplement and over 1,000 supplements have been found to contain prescription or experimental drugs.
The 1994 Dietary Supplement Health and Education Act (DSHEA) was created by the FDA. It requires supplement manufacturers to notify the FDA at least 75 days before bringing a new dietary ingredient to market and to provide evidence the new ingredient can reasonably be expected to be safe. So, how is the DSHEA program doing? The same 2016 Consumer Reports article paints a rather bleak picture: 90,000 dietary supplements are on the market and over 5,000 are being introduced every year; the agency has been notified of less than 1,000 new ingredient notifications in the past 20 years. In 2011, a draft of new rules was issued for DSHEA but was shelved after a long and angry debate by stakeholders. A 2016 draft of rules is still under review by the FDA's new Office of Dietary Supplements (ODS) which is charged with oversight of new ingredients into the market.
Consumer Reports has also noted that 43 per cent of those who regularly take at least one supplement were advised to do so by a doctor. Little research has centered around interviewing doctors as to why they recommend supplements, but one rationale offered for the recommendations is that doctors realize that if people are going to take supplements anyway, many physicians would rather provide a supplement that does not create a health risk when consumed with drugs that they have prescribed for a patient. That rationale becomes questionable when doctors actually sell supplements. The American Medical Association (AMA) has strongly disapproved the sale of products related to health from a doctor's office, saying "The profit motive can impair clinical judgement and undermine the primary obligation of physicians to serve the interests of their patients before their own." According to a 2014 Gallup Survey of 200 physicians, a staggering 94 percent now recommend vitamins or minerals to some of their patients; 45 percent have recommended herbal supplements also. And 7 percent are actually selling them in their offices.
Some supplement labels carry emblems with lofty, feel-good words such as "verified," "certified," or "approved." These labels are granted by organizations (NSF International, US Pharmacopoeia, etc.) insuring that the product contains the amount of the ingredient advertised on the label, but they do NOT, repeat NOT, guarantee a product has any therapeutic value whatsoever. Virtually all manufacturers point to studies which show the positive "scientific"results of their products. These studies are conducted with absolutely no-zip-nil governmental oversight. They are often directly or indirectly funded by a supplement manufacturer using measurements of a large number of things about a small number of people which virtually guarantees a "statistically significant" result. Critics note that ingredients which were submitted for approval as a new dietary ingredient (NDI) by one company but rejected by the FDA, can show up in products sold by other companies.
No discussion about false science claims, in my opinion, would be complete without reading an article by Cliff Weathers in Alternet e-magazine on July 17, 2014 entitled "4 of the Biggest quacks Plaguing America with False Claims About Science." Dr. Joseph Marcola is an osteopath who operates an internet site that promotes and sells dietary supplements. A sampling of his articles includes "13 Amazing Health Benefits of Himalayan Rock Salt", "Learn How Homeopathy Cured A Boy of Autism", and (referring to Vitamin D) "The Silver Bullet for Cancer?" He sells everything from Organic Sea Buckthorn Anti-Aging Serum to "worry-free" organic cotton tampons. He has been slapped by the FDA with numerous warning letters for his claims and the Better Business Bureau has given Mercola.com an F rating. "The Health Ranger," Mike Adams, has no medical credentials at all but (until recently being delisted by Google) had a Natural News website which Dr. David Gorski of the Science Based Medicine Website calls "a one-stop shop, a repository if you will, of virtually every quackery known to humankind..." Up next is "The Food Babe", Vani Hari, who has a background devoid of credentials other than a stint as a management consultant. Some of her most highly implausible ideas on food are: Microwaves kill food and remove nutrients and alter the properties of water. Water also changes its physical properties when the words Satan and Hitler are spoken nearby. Gorski says "Her strategy is very transparent...name a bunch of chemicals and count on the chemical illiteracy of your audience to result in fear at hearing their very names." Dr. Oz needs no introduction here, because millions tune in to his TV show. But he is not a quack per se. He is a professor at the Dept. of Surgery at Columbia University who has authored 400 medical research reports and as well as directing the Cardiovascular Institute at New York's Presbyterian Hospital. Weathers noted "Dr. Oz has been exposed as a daytime-television snake oil peddler, while being shamed during testimony before a U. S. Senate subcommittee on Consumer Protection." Oz admitted to the committee "While there is no such thing as a "miracle" supplement and many he promotes wouldn't pass scientific muster, my job is to be a cheerleader for the audience. When they don't think they have hope, I want to look and I do look everywhere, including alternative healing traditions, for any evidence that might be supportive to them." Chairwoman Claire McCaskill said that Oz was "giving people false hope." For me, he is merely a quack with credentials and a mountain of money.
Editor's note. My apologies for my long absence, but I spent months in 3 hospitals recovering from a severe case of Pneumonia and a virulent MRSA infection. I was in a coma for 12 days, but I am in dandy shape now.
Red Panda
Endangered Species
Our newest merger of food and health interests has created a new dietary love affair-- supplements. Dietary supplements (minerals, botanicals, herbs. minerals, amino acids, concentrates and extracts) have evolved into a new and controversial way to enhance nutritional value. I seek to shed some light on the size of the industry and how to determine if the supplements lining the shelves of your local pharmacy, grocery store, convenience store or website warehouse are safe to consume. (The industry is vast and complicated, so I will publish another blog next week to address the efficacy of various products by providing governmental and private websites which are well respected for providing objective information about supplements as well as answering questions about healthy lifestyles, many diseases and how our amazing human bodies function.)
Size: This industry is tricky to size because there are oodles of privately held companies, endless supply chains, and fuzzy product descriptions. Detailed reports can cost thousands, so I relied on official US governmental agencies such as the Food and Drug Administration and The National Institute of Health as well as respected journals like Nature or magazines such as Consumer Reports. The last reliable numbers show that in 2006 over half of adults used supplements (usage in 1988-1994 hovered around 24 per cent.) In 2000, $17.2 billion in profits was reported; in 2017--$36.1 billion. The boomer generation grew up when the industry was virtually nonexistent. Many of them had chuckled when people began taking pills for nutrition or weight loss. They thought it was just a craze; now at least half of adults 65 and older take daily vitamins and supplements.
Safety: People should note that the Food Drug Administration does not regulate supplements the same way as prescription medications involving years of tightly controlled clinical trials. The FDA's role is primarily to investigate supplements which reveal a potential for harm to users and to enforce the FDA's Good Manufacturing Practices which technically ensures production standards and licensing. Sounds good, but in reality, Consumer Reports reported in 2015 there were 15,000 supplement manufacturers in the US in 2015 and since 2010 the agency has inspected less than 400 of those companies per fiscal year. To remove a supplement from the market, the FDA must show that it poses a danger to consumers once it is already for sale. depending on reports from doctors, consumers and supplement manufacturers to report any issues. But even doctors might not connect the dots between an illness and the use of a supplement by a patient and call the FDA. The Government Accountability Office found that 5,000 more supplement related calls were going to poison control offices than to the FDA in 2015. The Sept. 2016 Consumer Reports magazine reported 23,000 people per year are treated at the ER after taking a supplement and over 1,000 supplements have been found to contain prescription or experimental drugs.
The 1994 Dietary Supplement Health and Education Act (DSHEA) was created by the FDA. It requires supplement manufacturers to notify the FDA at least 75 days before bringing a new dietary ingredient to market and to provide evidence the new ingredient can reasonably be expected to be safe. So, how is the DSHEA program doing? The same 2016 Consumer Reports article paints a rather bleak picture: 90,000 dietary supplements are on the market and over 5,000 are being introduced every year; the agency has been notified of less than 1,000 new ingredient notifications in the past 20 years. In 2011, a draft of new rules was issued for DSHEA but was shelved after a long and angry debate by stakeholders. A 2016 draft of rules is still under review by the FDA's new Office of Dietary Supplements (ODS) which is charged with oversight of new ingredients into the market.
Consumer Reports has also noted that 43 per cent of those who regularly take at least one supplement were advised to do so by a doctor. Little research has centered around interviewing doctors as to why they recommend supplements, but one rationale offered for the recommendations is that doctors realize that if people are going to take supplements anyway, many physicians would rather provide a supplement that does not create a health risk when consumed with drugs that they have prescribed for a patient. That rationale becomes questionable when doctors actually sell supplements. The American Medical Association (AMA) has strongly disapproved the sale of products related to health from a doctor's office, saying "The profit motive can impair clinical judgement and undermine the primary obligation of physicians to serve the interests of their patients before their own." According to a 2014 Gallup Survey of 200 physicians, a staggering 94 percent now recommend vitamins or minerals to some of their patients; 45 percent have recommended herbal supplements also. And 7 percent are actually selling them in their offices.
Some supplement labels carry emblems with lofty, feel-good words such as "verified," "certified," or "approved." These labels are granted by organizations (NSF International, US Pharmacopoeia, etc.) insuring that the product contains the amount of the ingredient advertised on the label, but they do NOT, repeat NOT, guarantee a product has any therapeutic value whatsoever. Virtually all manufacturers point to studies which show the positive "scientific"results of their products. These studies are conducted with absolutely no-zip-nil governmental oversight. They are often directly or indirectly funded by a supplement manufacturer using measurements of a large number of things about a small number of people which virtually guarantees a "statistically significant" result. Critics note that ingredients which were submitted for approval as a new dietary ingredient (NDI) by one company but rejected by the FDA, can show up in products sold by other companies.
No discussion about false science claims, in my opinion, would be complete without reading an article by Cliff Weathers in Alternet e-magazine on July 17, 2014 entitled "4 of the Biggest quacks Plaguing America with False Claims About Science." Dr. Joseph Marcola is an osteopath who operates an internet site that promotes and sells dietary supplements. A sampling of his articles includes "13 Amazing Health Benefits of Himalayan Rock Salt", "Learn How Homeopathy Cured A Boy of Autism", and (referring to Vitamin D) "The Silver Bullet for Cancer?" He sells everything from Organic Sea Buckthorn Anti-Aging Serum to "worry-free" organic cotton tampons. He has been slapped by the FDA with numerous warning letters for his claims and the Better Business Bureau has given Mercola.com an F rating. "The Health Ranger," Mike Adams, has no medical credentials at all but (until recently being delisted by Google) had a Natural News website which Dr. David Gorski of the Science Based Medicine Website calls "a one-stop shop, a repository if you will, of virtually every quackery known to humankind..." Up next is "The Food Babe", Vani Hari, who has a background devoid of credentials other than a stint as a management consultant. Some of her most highly implausible ideas on food are: Microwaves kill food and remove nutrients and alter the properties of water. Water also changes its physical properties when the words Satan and Hitler are spoken nearby. Gorski says "Her strategy is very transparent...name a bunch of chemicals and count on the chemical illiteracy of your audience to result in fear at hearing their very names." Dr. Oz needs no introduction here, because millions tune in to his TV show. But he is not a quack per se. He is a professor at the Dept. of Surgery at Columbia University who has authored 400 medical research reports and as well as directing the Cardiovascular Institute at New York's Presbyterian Hospital. Weathers noted "Dr. Oz has been exposed as a daytime-television snake oil peddler, while being shamed during testimony before a U. S. Senate subcommittee on Consumer Protection." Oz admitted to the committee "While there is no such thing as a "miracle" supplement and many he promotes wouldn't pass scientific muster, my job is to be a cheerleader for the audience. When they don't think they have hope, I want to look and I do look everywhere, including alternative healing traditions, for any evidence that might be supportive to them." Chairwoman Claire McCaskill said that Oz was "giving people false hope." For me, he is merely a quack with credentials and a mountain of money.
Editor's note. My apologies for my long absence, but I spent months in 3 hospitals recovering from a severe case of Pneumonia and a virulent MRSA infection. I was in a coma for 12 days, but I am in dandy shape now.
Red Panda
Endangered Species
Good info but a little heavy on the anti-vitamin side of the scale. Not all vitamins are created equal but a good quality supplement can be proven, via a blood test, to make a difference. It is true that all the vitamins you need are provided by food. If only we ate a perfect diet!
ReplyDeleteHi, Nancy--Yes, I agree with you about the blood test you reference, but I doubt whether the test is requested by most vitamin takers. My next blog which will post next week, focuses on a wide variety of supplements, although it is common knowledge that vitamins are the best sellers.
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