Supplement Industry Research 2016 
Compiled by Walter Sorochan

Posted January 24, 2016.

This article summarizes the status of dietary supplement industry and the federal agencies supposedly regulating it.  Attention to this topic was focused by a series of reports by Frontline.    Frontline Report video, Jan 19, 2016

supplementsandsafety Univ UtahThe information by Frontline in 2016 was not the first TV media to bring attention to the lack of dietary supplement control and ineptitude by the federal government agencies like the Federal Food and Drug Administration in protecting the public. There have been numerous observations reporting drug research that distorted research findings or distorting the outcome of health and food research using inappropriate research designs that resulted in reporting misinformation.  Here are just a few of these reports:

 

In the book, Bad Science, award-winning writer, Dr. Ben Goldacre [  MD ]  shows how pharmaceutical companies may intentionally or unwittingly distort research in drug trials. Goldacre: conflicts of interest    Ben Goldacre: bad science    In her new book, The Truth About Drug Companies: How They Deceive Us and What to Do About It (reviewed in an issue of Mother Jones), Dr. Marcia Angell, the former editor of the New England Journal of Medicine, contended that the industry has become a marketing machine that produces few innovative drugs and is dependent on monopoly rights and public-sponsored research. Meredith: The Truth  Then there is Nathan Newman who contended that biomedical research has been compromised by cozy relations with the pharmaceutical industry.  Newman: Big Pharma, Bad Science  "The trend of meddling with science to achieve predetermined outcomes has serious implications for researchers at academic institutions and government agencies as well as for the public at large?" said Dr. Linda Rosenstock, principal author and dean of the UCLA School of Public Health.  "We would like to think that the science used to make decisions that affect all of our lives is pure ... unfortunately, that is increasingly not the case?" UCLA observation 

Jon Barron summarized the shortcomings of the federal agencies in regulating food supplements as well as drugs.  He claimed that FDA doesn't really care if the claims are true or not and that it certainly has a bias in favor of pharmaceutical drugs.  Barron: FDA sympathy

The supplement industry came under attack in 2016 by FRONTLINE [Public Broadcast System ( PBS ) an investigative journalism that questions, explains and changes our world], The New York Times and the Canadian Broadcasting Corporation examine the hidden dangers of vitamins and supplements, a multibillion-dollar industry with limited FDA oversight.

There have been more than 400 recalls of supplements since 2008, mostly for products marketed for bodybuilding, weight loss and sexual enhancement, says Consumer Reports.  Jaslow: Hidden dangers of vitamins 2012

“The FDA [Food and Drug Administration] does not do any review of dietary supplements before they come onto the market, and I think that all consumers need to understand this,” Stephen Ostroff, M.D., acting commissioner of the FDA, tells FRONTLINE. The regulations for supplements are very lax: Unlike medicines, supplements are not put through the same tests by government authorities to determine whether or not they are safe. The manufacturers are given the responsibility of making sure that they are safe; they have to make sure that the products are correctly labeled, that they meet minimum quality standards and that they have no impurities or contaminants. Apart from that, there is very little governmental intervention when it comes to supplements.

The FDA. said, on January 12, 2016, that its review of the available information on BMPEA “does not identify a specific safety concern at this time.” A spokeswoman for the agency reiterated that statement on January 14, 2016. But Dr. Pieter A. Cohen, an assistant professor at Harvard Medical School and the lead author of the new study on BMPEA, said that the agency was abdicating its responsibility to remove dangerous and adulterated products from the market. “Instead of protecting the public’s health and enforcing the law, they are digging in their heels,” said Dr. Cohen, who is also an internist at the Cambridge Health Alliance. “By not acting on BMPEA in the face of overwhelming evidence that it has no role in supplements and may pose serious health risks, the F.D.A. is sending a strong signal to all supplement companies: you may introduce hazardous new products with impunity.”  O'Connor: Stop controversial supplements 2015

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA)  USFDA: supplement regulation

Labeling, regulated by the FDA, does not really help distinguish between good and bad supplements. “It is a complete unknown when you are buying a dietary supplement, unless you have some proof of what is in that product — it could be anything,” Sarah Erush, Pharm.D., of the Children’s Hospital of Philadelphia tells FRONTLINE.

Supplements come in several forms, which include:

    • Vitamins: Vitamins A, B, C, D, E and K.
    • Minerals: Calcium, iron, etc.
    • Other: Protein powders, enzymes, amino acids, herbal supplements, etc.

So, how can you take supplements without realizing it? A lot of processed food products, like fortified cereals for example, contain the same ingredients as supplements. Processing destroys the nutritional content in the food, so the manufacturers add synthetic nutrients so that they can claim that the product is healthy.  Gupta: Supplement dangers 2015 Vitamins and minerals (when not consumed in food form) are classified by the Federal Drug Administration (FDA) as dietary supplements. Amino acids, botanicals, herbs, and substances such as enzymes, organ tissues and glandulars, and metabolites, are also classified as dietary supplements.

Difference between food & Supplements: the quality of nutrition in actual, fresh food varies greatly from the quality of nutrition in supplements. Supplements are made with synthetic nutrients that are made by manufacturing processes that do not resemble biological processes at all. They are not intended to replace the healthy food in your diet.  Gupta: Supplement dangers 2015

Controversy:  Moyer: Controversy over vitamins 2014

An editorial published in the Annals of Internal Medicine last year offers a striking case in point. In it, researchers at Johns Hopkins University in Baltimore, Maryland, and other institutions proclaimed with certainty that the US public should “stop wasting money” on vitamin supplements. They argued that research has found no benefits, in part because most people in industrialized nations are well-nourished. Within months a counterattack ensued, headed by huge names in nutrition science and biochemistry, including Bruce Ames at the Children's Hospital Oakland Research Institute in California and Walter Willett at Harvard University in Cambridge, Massachusetts, who argued that vitamin deficiencies are, in fact, widespread in the United States and that supplements can help to close nutritional gaps.

Meir Stampfer, an epidemiologist at Harvard, considers the anti-vitamin editorial “garbage”. “I just felt sadness that such a poorly done paper would be published in a prominent journal and cause so much confusion,” he says.

The argument raises important questions about the quality and relevance of more than a century of studies. “There will always be two polar sides to this argument, and the main reason for that is we don't know the answers — we don't have evidence one way or the other,” says Paul Coates, who directs the Office of Dietary Supplements at the US National Institutes of Health (NIH) in Bethesda, Maryland.

Pooled together, evidence from double-blinded, placebo-controlled clinical trials suggests that hardly any nutrient supplements have a consistent health effect on people in developed countries. But many argue that the null findings reflect research deficiencies, including poor study design, inappropriate mixing of different kinds of data and misunderstandings about how much of a nutrient is enough. “The tools we've had in the past have been so crude — it's like we've been looking through a dirty window with the curtains closed,” says Susan Mayne, chair of the department of chronic disease epidemiology at the Yale School of Public Health in New Haven, Connecticut, and a member of the Institute of Medicine's Food and Nutrition Board, which establishes US nutrition guidelines such as the Dietary Reference Intakes for vitamins and minerals.

Although some scientists say that researchers can glean important insights from existing nutrition data, others, such as Robert Heaney, an endocrinologist at Creighton University in Omaha, Nebraska, argue that most existing studies are fatally flawed and that the whole enterprise needs a methodological overhaul.

“The trials we have in nutrition aren't answering the right questions, so they're not appropriate,” says Connie Weaver, head of the department of nutrition science at Purdue University in West Lafayette, Indiana, and a member of the Food and Nutrition Board. “What we're using now is pretty bad science.” 

 Summary:  there are several issues that need to be clarified, namely synthetic vs natural food supplements,  vitamin bioavailability and co-factor impact on nutrients.

Synthetic vs natural food supplements:   Many article writers, misinformed medical doctors and nutritionists claim that nutritional supplements are a waste of money and time and that these are not absorbed by the body.  What these claims fail to clarify is the reason that synthetic supplements are bad. 

The problem with vitamin-mineral supplements is that many vitamin and mineral supplements are chemically manufactured. Vitamin C is made from GMO corn [ synthesized as ascorbic acid ] while other B vitamins are made from toxic petroleum products in the laboratory synthetically with chemicals that do not come from their natural food sources. Thiel: Truth about vitamins

These supplements are made in a lab with the hope that these will mimic the way natural vitamins act in our bodies.  Many synthetic vitamins lack the transporter substances and natural co-factors [ helpers ] associated with naturally-occurring vitamins and minerals. Most of these co-factor substances are unknown at this time.   Wiki: other nutrients  The result is that synthetic supplements are recognized by the body as toxins and excreted from the body.

Most of the essential co-factor substances are unknown at this time.  We don't really know all the substances making up a natural vitamin, but the guess is that it could be 50 or more.  As of 1996, over 3,800 different compounds had been identified in foods as having nutritional significance. Duke, James Textbook  However, in a laboratory, twenty nutrients are about all that modern science can reproduce and put into a vitamin product made in a lab. Wiki: other nutrients   The significance of this information is that we know very little about all the plant substances needed for health.

Vitamin bioavailability:  Researchers in the past failed to account for the hidden co-factors in daily food that help ingestion of single vitamins, minerals and amino acids.  Related to this failure was a failure to explain how the body functions and how nutrients really prevent certain disorders and diseases.  For example, vitamin C  when eaten as limes, was able to prevent scurvy in the days of sailing ships.  Vitamin C had to have help from other co-factors, already present in other foods, to prevent scurvy, such as organic sulfur and calcium, although this has not been acknowledged by researchers. The false conclusion from such observation, that a single nutrient prevented a disease, carried over to viewing that a single nutrient could prevent a disease. Unfortunately, co-factors at that time were unknown.  This single cause idea was also used in medicine to use a single substance to treat a medical problem; ignoring the need to treat the whole body as well as a single organ or tissue. 

Likewise, niacin or vitamin B3 had to have help from other co-factors to prevent pellagra.  Pellagra is a disease characterized by diarrhea, dermatitis and dementia.  It occurs as a result of niacin [vitamin B-3] deficiency. Since tryptophan in the diet can be converted to niacin in the body, both of these need to be present to prevent pellagra. If left untreated, death is the usual outcome.  But .... there may be unaccounted as yet other amino acid, vitamin and mineral co-factors.  The best way to ensure that we get essential co-factors is from eating a balanced diet. But with mineral depleted soil, our food is fast becoming depleted in adequate and essential  minerals. So, this link between nutrients and diseases will continue to be a dilemma until we identify all the co-factors in bioavailability.  Since much of today's food is grown on depleted soils, we need to consider supplementing nutrient deficiencies by ingesting whole plant nutrient supplements.  All nutritional supplements, especially when derived from whole plant foods, are good for the body as these have the plants enzymes essential for digesting the plants, as well as the essential co-factors in probably the proper dosage ratios. 

Cofactors & Unknowns: The controversial comments about the shortcomings of previous nutritional research designs may be missing some really important information. Almost none of the research designs mention the impact that co-factors, whole-food complex, bioavailability and methylation may have on food ingestion, nutrition and wellbeing.  None of previous researches identified the vitamins as organic or synthetic. Ignoring these determining factors when designing a research study would definitely alter the research results and result in misinformation.  Sorochan: Cofactors 2015

Many research reports hide the nature of the vitamins that are used in their supposed double-trials research and end up misinforming you and others about the real outcome of their tainted research.  For more than 70 years we have been ingesting synthetic vitamins in our supplements and our fortified foods, believing that our health is being protected and improved.  But this has been an obvious deception by the supplement industry.  We have been mislead by supplement makers and even our own government. Sorochan: Vit-Min Supplement update

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References:

Barron Jon, "Sympathy for the FDA," Natural Health Newsletter, 10/18/2010. Barron: FDA sympathy

Boghani Priyanka, "Can Regulators Keep Up with the Supplements Industry?" KBS Frontline, January 19, 2016.  Boghani: supplement industry 2016

Childress Sarah, "Are Health Supplements Too Much of a Good Thing?" KBS Frontline, January 19, 2016.  Childress: Health supplements 2016

Duke, James, Handbook of Chemical Constituents of Grasses, Herbs, and other Economical Plants, CRC Press, Boca Raton , 1992.

Editorial Board, "Distorting drug trials," The Guardian. Original article in Goldacre Ben, "Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes," BMJ, November 29, 2009.   Goldacre: conflicts of interest

Goldacre Ben, "Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes," BMJ, November 29, 2009.Goldacre: conflicts of interest

Goldacre Ben, "Ghostwriters in the sky," The Guardian, September 18, 2010.   Ben Goldacre: bad science

Goldacre Ben, "Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes," BMJ, November 29, 2009.  Goldacre: conflicts of interest

Goldacre Ben, "Ghostwriters in the sky," The Guardian, September 18, 2010.  Ben Goldacre: bad science

Gupta Sanjana, "The Hidden Dangers Of Supplements," IndianaTimes, June 4, 2015.  Gupta: Supplement dangers 2015

Jaslow Tyan, "Consumer Reports: 10 hidden dangers of vitamins," CBS News, November 5, 2012.  Jaslow: Hidden dangers of vitamins 2012

Meredith Peter, "The truth about drug companies," Mother Jones, January 8, 2002.  Meredith: The Truth   New York Times Book Review   [Peter Meredith is an editorial fellow at Mother Jones.]

Moyer Melinda Wenner, "Nutrition: Vitamins on trial -After decades of study, researchers still can't agree on whether nutritional supplements actually improve health," Nature, 25 June 25, 2014.  Moyer: Controversy over vitamins 2014

Newman Nathan,"Big Pharma, Bad Science," The Nation, July 25, 2002.  Newman: Big Pharma, Bad Science

O'Connor Anahad, "Retailers to Stop Sales of Controversial Supplements," NewYork Tines, Well: ALTERNATIVE MEDICINE, April 9, 2015.   O'Connor: Stop controversial supplements 2015

Sorochan Walter, "Cofactors and coenzynes," November 10, 2015.   Sorochan: Cofactors 2015

Sorochan Walter, "Vitamin-Mineral Supplement update" Octover 1, 2013. Sorochan: Vit-Min Supplement update

Taddonio Patricia, "Supplements, What’s Really in the Bottle?" KBS Frontline, January 19, 2016.  Taddonio: What's in bottle? 2016

Thiel Robert, "The Truth About Vitamins in Nutritional Supplements," Doctor's Research.   Thiel: Truth about vitamins

UCLA, A newsletter for UC friends and advocates, January 08, 2002.  a href="http://www.universityofcalifornia.edu/news/article/3849">UCLA observation

USFDA, "Dietary Supplements."  USFDA: supplement regulation

Wikipedia, "B vitamins.  Wiki: other nutrients

Worth Katie, "Five Questions To Ask When Considering Health Supplements," KBS Frontline, January 19, 2016.  Worth: Questions about supplements 2016