We will not achieve this aim overnight. But working with researchers in many countries, we hope to help policymakers better understand the challenge and to occasionally provide them with some solutions. We’ll also blog about the latest challenges and successes involving falsified and substandard products.
The site’s regular contributors are Dr. Roger Bate, Dr. Amir Attaran, and Nick Slepko. Each has extensive knowledge and has published on the issue in both the academic literature and the mainstream press. Dr. Bate is the author of "Phake: The Deadly World of Falsified and Substandard Medicines". Bios are available in the dropdown menu under Mission. We’ll also feature guest contributions from various experts from time to time.
Whether you’re a policymaker, a member of the media, or someone who has had personal experience with fake or faulty products, we hope you’ll visit the site regularly to learn and take part in the discussion. For now, we invite you to learn more about our latest work through our first S4S Working Paper on substandard maternal health medicines in Ghana – uncovered in a study by Ghana’s FDA and US Pharmacopeial Convention, with support from USAID – and an accompanying op-ed by Dr. Roger Bate on the subject running in Foreign Policy. The op-ed is excerpted here:
“ACCRA, Ghana – Each time we take medicine, we assume that the manufacturer did its best to produce a quality product. Evidence is mounting, however, that some pharmaceutical manufacturers in countries like India cut corners and send low-quality products to major, developed markets. Worse still, they may have separate production lines for drugs they sell in developing markets like Africa, where poor quality is more likely to go unnoticed…
“…Consider the case of Ghana. In February 2013, the country’s Food and Drugs Authority (GFDA) and the United States Pharmacopeial Convention (USP), supported by the United States Agency for International Development (USAID), published a study on maternal-health products sold in Ghana. The GFDA and USP procured samples of oxytocin and ergometrine, used to treat potentially lethal post-partum hemorrhage. While Western hospitals routinely use such products to lower the risk of hemorrhage, Anna Adjoa, an obstetric nurse in Accra, explains that she uses them “mainly in emergency situations.” She says that, when these drugs don’t work, the chances are “far higher” that a new mother will bleed out during delivery.
“The GFDA study found that, of 303 samples, 220 (or 72 percent) were not registered in Ghana -- and all of those that were not registered failed basic quality tests, making them unfit for patients. Moreover, roughly 95 percent of the 80 samples that were subjected to all methods of quality and sterility testing failed. The companies that registered the products they sold (a legal requirement fulfilled by only three of the 16 companies examined) performed somewhat better, but most of their products failed, too. For example, Ciron, an Indian generics firm, registered its product Ergogen, but half of its samples failed.
“To quickly dispel other possible hypotheses about the test results: Degradation during storage is unlikely to have created poor quality. The samples made by a Swiss manufacturer all passed tests, and the conditions I have seen in major clinics are reasonable for storing the medicines in question. In other words, Ghanaians were not to blame. And while some of the products may have been intentionally falsified -- that is, made by criminal outfits pretending their products were those of legitimate companies -- USP, which has a history of conducting thorough product analysis, suggested only a few of the samples were fake. Subsequent investigations by the GFDA identified three Ghanaian companies (Lymens Medical Supplies Limited, Osons Chemists, and Sarkuff Pharmacy) importing most of these suspect products. Some of them may have come from bogus companies in China; Yikang Pharma Company, Nantong Jinghua Pharmaceutical Company Limited, and Jiangsu Huayang Company, for instance, appear not to have real addresses. But the majority of the products that failed quality testing were made by the legitimate companies that appeared on the packaging…”
Read the full op-ed in Foreign Policy.