Team:Florida Atlantic/HP/Gold

Florida_Atlantic

Gold Human Practices

The OWLGEMS held several meetings to discuss the many real life challenges of our times. We identified issues ranging from food and nutrition needs for the burgeoning population of the planet to environmental disturbance to disease misdiagnosis and the existential threat posed by emerging and re- emerging microorganisms. Some of the solutions we contemplated include creating photosynthetic insects, microbial meals and creating chemically controlled remediation biological micro-machines. After a thoughtful evaluation of the needs and detailed consultations with our experts and the expertise around us, it became clear to us that the problem of counterfeit and fake medicines and products deserved an important focus.

Working with the office of International Health & Bio-defense (OES/IHB of the US. Department of State, as a Jefferson Fellow, Dr. Esiobu conducted an extensive research on the subject, and created a technical document which showed that counterfeit and substandard medical (CSM) products constitute a major global public health threat, especially in Africa. The Department of State hosted meetings a multinational meeting to discuss the magnitude of the threat and to dialogue on regulatory steps that could be employed to stem the expanding problem. Some of the proposed regulatory solutions included controlling porous border trading, training and empowering food and drug regulators in detection of counterfeit drugs as well as improving the enforcement of penalties for defaulters. In the technical document and subsequent publication by Esiobu and her graduate students, there was a strong correlation between the prevalence of counterfeit medications and drug resistance. Indeed several peer reviewed articles confirm the need for action to stop the spread and use of counterfeit medications.

It is estimated that 10 - 20% of all medicines in circulation globally and more than 30% in developing countries are substandard. Counterfeits of most essential drugs, intravenous fluids, and diagnostic kits have been described but the majority of literature focus on anti-malarial and other anti-microbial drugs which constitute 70% of the current CSM market. Adulterated life style drugs and pharmaceuticals for treating Non-communicable diseases (NCDs) are on the rise in developed countries. And the surge in global marketing of prescription drugs by companies like Amazon is only likely to exacerbate the problem around the world. In the absence of adequate control measures, the vulnerability of developed countries to counterfeit perpetrators could be quite significant, where standard manufacturing could be compromised by poor quality of or counterfeited imported ingredients in the pharmaceutical industry. Gauging the actual extent of the adverse effects of CSM is difficult because of the paucity of primary research articles, confused diplomacy, and denials, but the general consensus is that the magnitude of the problem is huge and growing with the globalization of pharmaceutical trade. African nations lose at least $12 billion annually in economic output – from re-treatment and damage control palliatives resulting from the aftermath of havoc wreaked by purported fake anti-malaria. The high toll of Tuberculosis (TB) and related deaths in sub-Saharan Africa is estimated at $50 billion annually and counterfeit medicines are blamed for a high proportion of this public health scourge. More people die every year from counterfeit medicines than from illicit drugs globally. Of the one million malaria deaths that occur worldwide each year, 200,000 are reportedly the result of counterfeit anti-malarial drugs. The WHO reports that 700,000 Africans die annually from consuming fake anti-malaria or anti-tuberculosis drugs, most of which originate from Asia. Counterfeited and substandard anti-infectives containing sub- therapeutic amounts of active ingredients contribute significantly to the selection and spread of drug- resistant pathogens, whose impact could easily reach pandemic proportions. Conversely, false reports of drug resistance to anti-malaria have resulted from treatment failures due to the use of fake drugs; this contributes to the erosion of confidence in authentic medicines by physicians and patients. Fake antimicrobial drugs used for livestock prolong disease morbidity, a prime condition for genetic drifts and shifts of pathogens, leading to emergence of new disease etiologies. Emergence of multi-drug resistance agents, prolonged sick periods, and increase of patient carrier state threaten global health and well-being. Counterfeiting ruins years of investments in drug discovery while compromising international health. Adverse effects, including allergies to covert pharmaceuticals in CSM are widespread. Meanwhile the counterfeit drug manufacturing is at least a $70 billion trade globally.

The FDA works with US Bureau of Customs and Border patrol to identify suspect packages from other countries. Combating this emerging public health threat ultimately requires international cooperation. A harmonized international surveillance and legislation with severe sanctions/punishment for counterfeiting; similar to the European Medicrime convention of 2010.

Because most of the counterfeit drug detection systems available are expensive, requiring a lot of expertise; we believe that equipping the consumers and regulators with a simple reliable biosensor – the MEDICOLI created through machine learning of natural systems by the OWLGEMS could significantly improve the ability to detect these drugs and reject them at multiple levels in the society. We hope to conduct outreach events and public dialogues on this important subject as we progress to finetuning our product.

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