Health Letter, January 2018
By Michael Carome, M.D.
If you’re not outraged,
you’re not paying attention!
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A patient develops a life-threatening disease, and her doctor prescribes a medication that can easily cure her. She goes to the local pharmacy and receives a bottle of pills that look authentic, but instead of having the life-saving active ingredient, the pills contain only cornstarch. Unfortunately, for many patients around the globe, this type of scenario is all too common. Even patients in the U.S. are not immune to this growing global scourge.
On Nov. 28, 2017, the World Health Organization (WHO) released new research showing that approximately one in 10 medical products circulating in low- and middle-income countries around the world are fake or substandard. The organization noted that the fake medications commonly contain cornstarch, potato starch or chalk instead of the purported, often life-saving active ingredients. Other medications contain amounts of the intended active ingredient that are either dangerously high or ineffectively low. Still others are tainted with highly toxic ingredients that are not listed in the product labeling.
In 2013, the WHO launched its voluntary Global Surveillance and Monitoring System (GSMS) for substandard and falsified (fake) medicines, vaccines and certain diagnostic tests. The WHO defines “substandard” medical products as those that fail to meet their quality standards or specifications and “falsified” medical products as those that deliberately and fraudulently misrepresent their identity, composition or source.
From 2013 to 2017, the WHO’s GSMS received 1,500 reports of substandard and fake medical products. The largest number of reports (42 percent) have come from Africa.
Many assume that high-income countries with strong regulatory agencies — such as the Food and Drug Administration in the U.S. and the European Medicines Agency in the E.U. — are able to stop substandard and fake medical products from reaching patients. But every region of the world, including Western Europe and the U.S., has reported the detection of such products to the WHO. Moreover, the reports submitted to the WHO undoubtedly represent the tip of the iceberg because many cases of substandard and fake medical products go undetected or unreported.
The six most commonly reported categories of substandard and fake medical products in the WHO database are the following:
- Malaria medications (20 percent), reported by 26 countries
- Antibiotics (17 percent), reported by 46 countries
- Anesthetics and painkillers (9 percent), reported by 29 countries
- Lifestyle products, including products for cosmetic use, erectile dysfunction, body-building and dieting (9 percent), reported by 37 countries
- Cancer medications (7 percent), reported by 19 countries
- Heart medications (5 percent), reported by 22 countries
Substandard and fake medications can be found in illegal street markets, pharmacies, clinics and hospitals and via unregulated websites.
In its recent report, the WHO clearly explained why substandard and fake medical products pose a significant threat to the health of patients who are exposed to them:
When medicines do not work the way they should (as is the case with most substandard and falsified medical products), they can prolong illness and the inconvenience, time off work and often the misery that go with it. Doctors and other health workers waste precious time trying out alternative treatments, when all that is really needed is a quality version of the same treatment. In the worst cases…people die, either from untreated disease or because the product itself kills them.
The exact number of patients injured or killed by substandard and fake medical products is unknown. To better estimate the health impact of substandard and fake medical products, the WHO commissioned two studies. The first, which was conducted by a team of researchers at the University of Edinburgh, assessed the impact of using substandard and fake antibiotics in the treatment of pneumonia in children ages 0 to 5 years. Assuming that 10 percent of antibiotics are substandard or fake, the researchers estimated that between 72,000 and 169,000 children worldwide would die annually from receiving such antibiotics for pneumonia.
The second study, which was carried out by researchers at the London School of Hygiene and Tropical Medicines, estimated that approximately 116,000 additional deaths from malaria could be caused every year by substandard and fake malaria medications in sub-Saharan Africa.
In addition to threatening the health of individual patients, substandard and fake medications endanger public health more broadly. For example, substandard antibiotics that contain insufficient amounts of the prescribed active ingredient can promote the development of antibiotic-resistant microorganisms and the spread of antibiotic-resistant infections around the world.
The WHO correctly points out that greed, which underlies so much criminal activity, “continues to be a driver of the trade in falsified medical products.” Rapidly growing global demand for medicines, vaccines and other medical products has created new opportunities for unscrupulous traders, businesses and criminals.
Reining in the problem of substandard and fake medical products will require an enormous effort by countries around the globe. The globalization of the supply chain for medications, in which the production of a particular medication typically involves several countries, has made it more difficult to regulate medical products and to detect and remove substandard and fake medical products before they reach patients.
To avoid millions of preventable deaths in the future, national regulators in all countries must be adequately trained — and provided with the necessary tools — to prevent, detect, report and respond quickly to the distribution of substandard and fake medical products. The U.S. should play a leadership role in ensuring the provision of such training and tools.