Pill Pushing©

The vitamin industry - For your health or their wealth? - (6/1/2017)

By Dr. Ron Gasbarro

Society at the time
The year was 1940. Bugs Bunny made his official debut in the animated cartoon A Wild Hare. Walt Disney's animated film Pinocchio was released. The Academy Award for best actor was James Stewart for The Philadelphia Story, while the best actress award went to Ginger Rogers for Kitty Foyle. Glenn Miller’s In The Mood was a number 1 hit in the US and beyond. That same year, Richard and Maurice McDonald opened a barbecue drive-in in San Bernardino, California, which would later become McDonald’s, the fast-food chain that has killed over 20 billion cows and counting.  

In 1940, Germany invaded Denmark, Norway, France, Luxembourg, Belgium, and the Netherlands intensifying World War II. Franklin D. Roosevelt was elected for an unprecedented third term as US president. President Roosevelt signed the Selective Training and Service Act, making it the first military draft to be created during peacetime in the US. Because of the war, Nobel prizes for physics, chemistry, physiology or medicine, literature, and peace were not awarded.

 

In 1940, Tom Brokaw, veteran American television news reporter as well as Anita Bryant, singer, orange juice shill and serial homophobe was born. The same year comedian and actor Ben Turpin died and Leon Trotsky, Russian revolutionary was assassinated. 

A gallon of gas was 11 cents in 1940 and the average cost of new car was $850. Among the new products introduced that year were York Peppermint Patties™, the Remington® Electric Razor for Women™, and One-A-Day™ vitamins.     

The drug(s) in question: Vitamins 

Technically, a vitamin is not a drug.  Rather, a vitamin (Latin: vita [“life”] + amine [amino acids]) is an organic compound and a vital nutrient that an organism requires in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when the organism cannot synthesize the compound in sufficient quantities, and it must be obtained through the diet; thus, the term vitamin is conditional upon the circumstances and the particular organism. For example, ascorbic acid (one form of vitamin C) is a vitamin for humans, but not for most other animal organisms. 

Vitamins are classified as either water-soluble or fat-soluble. In humans, there are 13 vitamins: 4 fat-soluble (A, D, E, and K) and 9 water-soluble (eight B vitamins and vitamin C). Water-soluble vitamins dissolve easily in water and, in general, are readily excreted from the body to the degree that urinary output is a strong predictor of vitamin consumption. Because they are not as readily stored, more consistent intake is important. Fat-soluble vitamins are absorbed through the intestinal tract with the help of lipids (fats). Because fat-soluble are more likely to accumulate in the body, they are more likely to lead to hypervitaminosis than are water-soluble vitamins. 

The good, the bad, and the ugly 

You can walk into any pharmacy, any health food store, and any supermarket and see many shelves stacked with all sorts of vitamin supplements. The irony comes when the vitamin aisle is surrounded by thousands of food items which – arguably – contain even more vitamins. So do you need vitamin supplements to keep you alive? 

According to Allegra Kirkland of alternet.org, Americans are not only swallowing vitamins but also certain other substances such as pulverized houseplants, powdered rice and even traces of psychiatric drugs. People may be shocked to find out that hardly any regulatory requirements exist for vitamins and supplements in the US. The $36 billion industry has avoided Food and Drug Administration rules that generic medications must adhere to, such as testing products to prove that they are effective and safe before they go on the market. In fact, a 1976 congressional amendment pushed through by Democratic Senator William Proxmire ensures that the FDA can never limit the potency of vitamin pills, classify them as drugs, or require that they can only contain useful ingredients. This loose oversight absolves supplement manufacturers from all types of blunders, from mislabeled ingredients to super-megadoses that can leave consumers with lasting health problems. 

Arriving at this regulatory no man’s land was no easy feat, says Kirkland. Since the scientific underpinnings of vitamins were first discovered in the 1920s, a two-headed pro-vitamin propaganda campaign has been launched by the Dietary Association of America and by industry lobbyists and their supporters in Congress. In the 1940s and ‘50s, food scientists and marketers promoted vitamin- and additive-enriched foods, advertising their longer shelf lives and vague “nutritional benefits.” This strategy, which allows companies to artificially inflate prices and promote nutritionally vacant products as healthy, endures. At the same time, alternative medicine advocates, supplement industry leaders and their beneficiary in the House and Senate have savagely fought proposed regulations, arguing that they infringe on our ability to make our own healthcare decisions.

As journalist Catherine Price argues in her book Vitamania: Our Obsessive Quest for Nutritional Perfection, this multi-decade effort has worked. Over half of American adults currently use dietary supplements, according to the latest Centers for Disease Control figures, and even those of us who do not likely assume they are safe. We have blindly accepted vitamins and supplements as miracle cures for our ailments, without even knowing what we are putting into our bodies. 

What do the clinical trials show? 

Let’s say that all vitamin supplements are uniform in dose and devoid of any untoward fillers. Can vitamins extend your life or make you healthier? Or prevent disease?  

Supplementation is important for the treatment of certain health problems, such as calcium deficiency [NIH, 2013], but scant evidence exists that proves a nutritional benefit when used by otherwise healthy people. Two large trials (n = 27,658) reported lower cancer incidence in men taking a multivitamin for more than 10 years [Fortmann, 2013]. The study, which included women, showed no effect in that gender group. High-quality studies (n = 324,653) of single and paired nutrients (such as vitamins A, C, or D; folic acid; selenium; or calcium) were scant and heterogeneous and demonstrated no clear evidence of either benefit or harm. Neither vitamin E nor β-carotene prevented cardiovascular disease or cancer, while β-carotene increased lung cancer risk in smokers.

A hefty body of research has been amassed to help inform our decisions about vitamins [Huang, 2006; Morris, 2003; Ritenbaugh, 2003; Atkins, 2003]. A very large study was published in 2009 (Multivitamin Use and Risk of Cancer and Cardiovascular Disease in the Women’s Health Initiative Cohorts) that followed 161,808 post-menopausal women over 8 years [Neuhouser, 2009]. The study found no benefit for heart disease, cancer risk, or overall survival. This study follows other studies showing no benefit from routine supplementation.

A systematic review of multivitamin-multimineral (MVM) use and cardiovascular disease, cancer incidence, and total mortality analyzed 12 cohort studies and 3 primary prevention randomized controlled trials [Alexander, 2013]. Based on the available scientific evidence to date, supplementation with MVMs does not appear to increase all-cause mortality, cancer incidence or mortality, or CVD incidence or mortality and may provide a modest protective benefit.

Two studies revealed that gender may determine whether vitamin supplementation can prevent cardiovascular disease (CVD). The first studied 18,530 male physicians aged ≥40 years from the Physicians' Health Study I cohort who were free of CVD and cancer at baseline [Rautiainen, 2016]. During a mean follow-up of 12.2 years, there were 1,697 incident cases of major CVD (defined as nonfatal myocardial infarction, nonfatal stroke, and CVD death). In multivariable-adjusted analyses, no significant associations were observed among baseline multivitamin users compared with nonusers for the risk of major CVD events, whereas a self-reported duration of 20 or more years at baseline was associated with a lower risk of CVD. The second prospective cohort study was conducted in which 37,193 women from the Women's Health Study aged ≥45 years and free of CVD and cancer at baseline who were followed for an average of 16.2 years [Rautiainen, 2015]. In this study of middle-aged and elderly women, multivitamin use was not associated with the long-term risk of major CVD events, MI, stroke, cardiac revascularizations, or CVD death.

The impact on society 

How did the vitamin industry convince Americans that they need to bulk up on vitamin A, vitamin C, various forms of vitamin B, and other vitamins or multivitamin supplements? "Vitamin manufacturers argue that a regular diet doesn't contain enough vitamins and that more is better," and most people wrongly assume that "at the very least, excess vitamins can't do any harm," Paul Offit, an infectious disease specialist at Children's Hospital of Philadelphia, said in The New York Times in 2013.  
But much of the blame lies with a flawed genius, Linus Pauling, Offit says. Pauling, the father of molecular biology and near-discoverer of DNA, was "so spectacularly right that he won two Nobel Prizes and so spectacularly wrong that he was arguably the world's greatest quack," Offit wrote in The Guardian. Starting in 1966, Pauling started evangelizing about the wonders of vitamin C, making outrageous claims about its salutary effects. In 1970, Pauling published a bestseller, Vitamin C and the Common Cold, arguing that 3,000 mg of the vitamin each day would eradicate the cold. He went on to insist that a multitude of vitamins, including A, E, and beta-carotene could treat or cure a whole host of maladies, from cancer to AIDS. Study after study after study proved him wrong. Pauling really believed his claims, but the vitamin industry had more cynical motives: Money, as Offit recounted in The New York Times. The Food and Drug Administration proposed regulating vitamin supplements containing more than 150% of the recommended daily allowance in December 1972, meaning "vitamin makers would now have to prove that these 'megavitamins' were safe before selling them," said Offit. 

Where vitamins are today 
Despite a 2013 study which revealed that vitamins do not provide health benefits and may even cause harm, a Gallup poll shows that half of Americans report regularly taking vitamins or other mineral supplements [Fortmann, 2013]. The study, published in the Annals of Internal Medicine, was accompanied by an editorial titled, "Enough Is Enough: Stop Wasting Money on Vitamin and Mineral Supplements." [Guallar, 2013] "The message is simple," the editorial asserted. "Most supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided." Vitamin sales total nearly $12 billion annually.

Older and wealthier Americans most likely to take vitamins
A significant generation gap exists between those who use vitamins and those who do not. About one-third of 18- to 29-year-olds say they regularly take vitamins or mineral supplements. Vitamin use increases among older Americans, with regular use climbing higher than 50% in the 50 to 64 age group and continuing upward to encompass a solid majority of seniors (68%) [Guallar, 2013].

Vitamin use also rises with education. Forty-three percent of those with no more than a high school education say they take vitamins regularly, but vitamin use steadily rises with college experience. Regular vitamin use also increases with income. A majority of those making less than $24,000 per year do not take vitamins, but a majority of all other income categories take vitamins, topping out at 56% for those whose household income is $90,000 or more per year.

A majority of women (54%) say they take vitamins or mineral supplements regularly, yet only 46% of men say they take them. Factors that may contribute to the disparity include women taking more prenatal vitamins or calcium supplements for those who suffer from osteoporosis.

Get nutrients from food alone? 
Whole foods are better than dietary supplements. This may be true, but this is not something that can be proven in a randomized clinical study. Advocates for the preventive benefits of nutrition often claim that nutrition from food is better than nutrition from vitamins. This is partly based on other observational studies that link a diet rich in fruits and vegetables with lower risk of heart disease and certain cancers. However, another way to interpret this discrepancy is not that vitamins from food are better than vitamins from pills but rather that vitamins are not what is healthy about such diets.  For example, a diet rich in fruits and vegetables may be healthy because it is not full of animal fat. Or, people who take care to eat such diets may also generally take better care of themselves [Novella, 2009].

What’s the bottom line? 
For centuries, foods and beverages have been known to contain vitamins, but only in the last century have multivitamins and other nutritional supplements become available for purchase and consumption. Since then, the use of vitamin supplements has been controversial. Despite this, half of American adults today take vitamins, including as many as 2/3 of older Americans and those with high levels of education. With so much money at stake, recent findings in the medical field are bound to be points of contention for some time to come. The potential exists for disruption of a multibillion-dollar industry and the alteration of lifelong habits of millions of Americans.

Ron Gasbarro, PharmD, is a registered pharmacist, medical writer, and principal at Rx-Press.com. Read more at www.rx-press.com

References 
Alexander DD, Weed DL, Chang ET, Miller PE, Mohamed MA, Elkayam L. A systematic review of multivitamin-multimineral use and cardiovascular disease and cancer incidence and total mortality. J Am Coll Nutr. 2013;32:339-54. 

Atkins D, Shetty P. Routine vitamin supplementation to prevent cancer: update of the evidence from randomized controlled trials 1999-2002. Rockville, MD, USA: Agency for Healthcare Research and Quality; 2003.

Fortmann SP, Burda BU, Senger CA, Lin JS, Whitlock EP. Vitamin and mineral supplements in the primary prevention of cardiovascular disease and cancer: An updated systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013;159:824-34.

Guallar E, Stranges S, Mulrow C, Appel LJ, Miller ER 3rd. Enough is enough: Stop wasting money on vitamin and mineral supplements. Ann Intern Med. 2013;159:850-1.

Huang HY, Caballero B, Chang S, et al. Multivitamin/mineral supplements and prevention of chronic disease. Evid Rep Technol Assess (Full Rep). 2006:1-117.

Morris CD, Carson S. Routine vitamin supplementation to prevent cardiovascular disease: a summary of the evidence for the U.S. Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality; 2003.

National Institutes of Health (NIH). Health information. Use and safety of dietary supplements; 2013. Available at: https://ods.od.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx 

Neuhouser ML, Wassertheil-Smoller S, Thomson C, et al. Multivitamin use and risk of cancer and cardiovascular disease in the Women's Health Initiative Cohorts. Arch Intern Med. 2009;169:294-304. 

Novella S. Another negative study of vitamins. Science-Based Medicine; 2009. Available at: https://sciencebasedmedicine.org/another-negative-study-of-vitamins/

Rautiainen S, Lee IM, Rist PM, et al. Multivitamin use and cardiovascular disease in a prospective study of women. Am J Clin Nutr. 2015;101:144-52.

Rautiainen S, Lee IM, Rist PM, et al. Multivitamin use and the risk of cardiovascular disease in men. J Nutr. 2016;146:1235-40.

Ritenbaugh C, Streit K, Helfand M. Routine vitamin supplementation to prevent cancer: a summary of evidence from randomized controlled trials for the U.S. Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality. 2003.
 


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