Counterfeit pharmaceuticals kill hundreds of thousands of people every year

Dietary supplements are big business. Three out of four Americans take one or more on a regular basis, and for older Americans the fraction is four out of five. One in three children also takes supplements. The estimated number of supplement products increased form 4,000 in 1994 to 50,000-80,000 today. Out of pocket expenditures for herbal and complementary nutritional products are about $50 billion, reports Henry Miller. ¹ One of the greatest hoaxes perpetrated on health conscious American consumers is the hype and outright fraud of dietary supplements that don't work and are sometimes dangerous.

Most studies suggest that taking vitamins and supplements is usually completely unnecessary and might be harmful. A study of almost forty thousand women, for instance, found no benefit to taking a range of supplements and concluded that there was little justification for the general and widespread issue of dietary supplements.² Research has also found that vitamin C does not prevent cancer or, for that matter colds; supplementation with some vitamins (e.g., A and E) may increase the risk of certain cancers; taking supplements with omega-3 may increase the risk of prostate cancer; and according to a report from the Harvard School of Public Health, further supplementation with high doses of the vitamin B has not been found to be beneficial and might actually cause harm. Other studies have found that many supplements are often not what they say they are. A 2013 study from the University of Guelph, for example, did a blind study of commercially available supplements and found that 'most of the herbal products were of poor quality, including considerable product substitution, contamination and use of fillers.' Remarkably, these researchers found some product substitution—the use of another, unlabeled herb in the place of the main ingredient—in products of 83 percent of the companies tested. In other words, only 17 percent of the companies were providing products that matched what the label said. This is, of course, both dangerous and unethical.² Canadian researchers tested popular supplements from 12 companies in 2013 and found that products from just two of the companies contained 100 percent of the supplement. The rest had been contaminated with other plants, had mislabeled ingredients, or contained mostly fillers like rice, soy or wheat. The New York Attorney General's office did similar DNA tests of herbal supplements in early 2015 and found that most didn't contain any of the actual herb on the label.³

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Over-the-counter melatonin is not commonly regulated by governing bodies around the world, such as the US Food and Drug Administration. Scientific evaluations of over-the-counter brands have found melatonin concentrations that range from 83 percent less than claimed on the label, to 478 percent more than stated. ⁴ Popping vitamins is no substitute for eating nutritious foods a recent study led by researchers at Tufts University suggests. A decade-long observational study of more than 30,000 people finds that certain vitamins and minerals may help extend your life and keep you from dying of cardiovascular disease but only if you get those beneficial nutrients from foods, not supplements. ⁵ The study didn't just find a lack of benefits from supplements. It also found potential harms. Getting high doses of calcium (1,000 mg or more per day) from supplements—but not from foods—was linked to higher cancer mortality risks in the study. Likewise, people taking vitamin D supplements who didn't have vitamin D deficiencies may have higher risks of all-cause mortality and death from cancers. It's unclear from this observational study exactly why the same vitamins and minerals had different effects based on whether they were, say, chewed from a salad or gulped in a tightly packed capsule. But, it's likely due to the fact that our bodies are tuned by evolution to best absorb and use micro-nutrients at the levels and ratios found in foods. ⁶

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An earlier study led by researchers at St. Michael's Hospital and the University of Toronto also concluded that most popular vitamin and mineral supplements provide no health benefits.⁷ How bad are supplements? There are plenty of hard data to answer that question. Results were reported by the Centers for Disease Control and Prevention and FDA researchers which analyzed representative surveillance data from 63 hospital emergency departments over a 10 year period (2004-2013). The statistical analysis projected about 23,000 emergency room visits annually resulting from ingestion of supplements. ⁸ These findings were confirmed by a 2017 study published in the Journal of Medical Toxicology, which found that US Poison Control Centers receive a call every 24 minutes, on average, due to exposures to dietary supplements. The rate of calls increased by almost 50 percent from 2005 to 2012, with a total of 274,998 incidents reported from 2000 through 2012. About 4.5 percent—more than 12,300 cases—resulted in serious medical complications.¹

Supplements From Developing Countries

Counterfeit pharmaceuticals kill hundreds of thousands of people every year. Although most pervasive in poor countries, counterfeit drug trafficking is a worrying new phenomenon in the developed world.

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In his groundbreaking study Roger Bate traces pharmaceutical counterfeiting around the world, from developed nations, where counterfeits often target 'lifestyle' such as Viagra, to developing countries, where counterfeiters favor therapeutic medicines such as anti-malarials and antibiotics. Enforcement in developing nations is hampered by inadequate education, feeble regulation, and sluggish policing of existing laws. ⁹ It is no secret that India is unable to regulate its drug manufacturers. India's own Parliamentary Standing Committee on Health and Family Welfare candidly admitted in two recent reports that as much as eight percent of medicines in India are of substandard quality, some of which can harm patients, and others of which were never lawfully approved at all. It warned of an appalling shortage of drug inspectors in India's states: only 848, when 3,200 are required. ¹⁰ Might the same be happening to Americans, now that 80 percent of the medicines we consume are imported? India's top medicine export market is, after all, the United States.

Some Possible Good News

Since 1994, supplements have not been subject to the same regulatory requirements as prescription drugs—or in fact to any meaningful regulation at all, except when it becomes known that they are contaminated with a real drug or some other substance known to be harmful. Only then can the FDA act. Reports Henry Miller, “Twenty-five years after politically driven legislation bizarrely defined those products as 'food,' during which time the Food and Drug Administration ignored untold numbers of adverse events, including deaths, regulators finally announced in February 2019 that they will increase oversight of the dietary supplements industry.” ¹

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References

1. Henry I. Miller, “Will dangerous dietary supplements finally be reined in?” henrymillermd.org, April 23, 2019
2. Timothy Caulfield, Is Gwyneth Paltrow Wrong About Everything, (Boston, Beacon Press, 2015)
3. John Swartzberg, “Dietary supplements: can you separate fact from fiction?”, livescience.com, May 12, 2015
4. L. A. Erland and P. K. Saxena, “Melatonin natural health products and supplements: presence of serotonin and significant variability of melatonin content,” Journal of Clinical Sleep Medicine, 13(2), 275, 2017
5. Fan Chen et al., “Association among dietary supplement use, nutrient intake, and mortality among US adults: a cohort study,” Annals of Internal Medicine, May 7, 2019
6. Beth Mole, “The nutrition study the $30 billion supplement industry doesn't want you to see,” arstechnica.com, April 11, 2019
7. David J. A. Jenkins et al., “Supplemental vitamins and minerals for CVD prevention and treatment,” Journal of American College of Cardiology, 71 (22) 2570, 2018
8. Andrew I. Geller et al., “Emergency department visits for adverse events related to dietary supplements,” New England Journal of Medicine, 373, 1531, 2015
9. Roger Bate,”Making a killing: he deadly implications of the counterfeit drug trade,” aei.org, April 28, 2008
10. Amir Attaran, “India's bad drugs and even worse excuses,” realclearscience.com, June 13, 2103