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Opportunistic business models in the generic drug market
Published in Rachel Kim, Economics and Management in the Biopharmaceutical Industry in the USA, 2018
As mentioned, Daraprim®, or pyrimethamine, is an antiparasitic drug used primarily to treat toxoplasmosis in the United States. Although toxoplasmosis is a rare disease, the only available treatment is Daraprim®. Generic manufacturers have decided not to conduct bioequivalence studies against the reference drug, in this case, Daraprim®, and apply for FDA approval of generic versions. Keep in mind, it is unusual for orphan drugs not to have many competitors. In most cases, drug companies pursue orphan drugs, since many orphan drugs cost hundreds of thousands of dollars per patient per year (Langreth & Armstrong, 2015; Phillips, 2013). Part of the reason generic companies have chosen not to try and receive FDA approval for Daraprim® is because it has a small patient population and the duration of treatment is only six weeks. Normally, most orphan drugs must be taken for life. In addition, Turing’s competition-preventive techniques do not allow possible generic manufacturers from buying Daraprim® for use in their FDA applications. Due to these reasons, it does not appear that alternative therapeutics to Daraprim® will make it to market any time soon (Sarpatwari, Avorn, & Kesselheim, 2014; Van der Gronde, Groot, & Pieters, 2017). Furthermore, the prohibitively high cost of Daraprim® has not been sustainable for hospitals and has left patients with thousands of dollars in co-payments (Calderwood & Adimora, 2015). Due to the high financial burden to patients and the limited access to Daraprim®, physicians are considering alternative therapies (Carrier, Levidow, & Kesselheim, 2016; PR Newswire, 2015; Sarpatwari, Avorn, & Kesselheim, 2014).
QuEChERS-based analysis and ecotoxicological risk of select antibiotics in dumpsite leachates, hospital wastewater and effluent receiving water in Ibadan, Nigeria
Published in Journal of Environmental Science and Health, Part A, 2022
Akinranti S. Ajibola, Tobiloba E. Awoyemi, Oluwadamilare T. Fasogbon, Gregory O. Adewuyi
Frequency of detection of sulfadoxine in ASH wastewater samples and UCH wastewater samples was 100%. This indicates that sulfadoxine was administered or dispensed on frequent basis during the period of sampling. Apart from its usage as an antibiotic, sulfadoxine in combination with pyrimethamine is used to treat and prevent malaria,[31] a disease caused by parasites through the bite of a mosquito. Malaria poses a significant public health challenge in Nigeria and an estimated 76% of Nigeria’s population are at risk of malaria by living in high transmission areas.[32] Thus, high consumption of various anti-malaria drugs, including sulfadoxine/pyrimethamine formulation is envisaged in Nigeria. The maximum concentration of sulfadoxine measured in ASH wastewater was 107.5 µg L−1 whereas the highest concentration of sulfadoxine in UCH wastewater was 35.2 µg L−1. Sulfadoxine was found in higher amount in ASH wastewater than in UCH wastewater. The high concentrations of sulfadoxine in wastewater from both hospitals give an indication that high amounts of sulfadoxine was prescribed and administered in treating patients during the period of sampling. Sulfadoxine concentration in Dandaru river (upstream) ranged from < LOQ to 117.1 µg L−1 while a concentration range of < LOQ to 46.5 µg L−1 was measured in Dandaru river (downstream). The higher levels of sulfadoxine measured in the effluent receiving water than the levels quantified in UCH wastewater show that there were other inputs apart from UCH wastewater. It should be noted that Dandaru River flows through the Agodi gardens which is a recreational area. Thus, expired or unused drug (containing sulfadoxine) might be disposed into the river by tourists. Studies on the presence of sulfadoxine in hospital wastewater are scarce in literature. Ngigi et al.[13] reported concentrations of below 0.02 µg L−1 in hospital wastewater and river water (Table 4). The maximum concentration of 0.46 µg L−1 in river water was determined for sulfadoxine by Wei et al.[41] and up to 0.0013 µg L−1 in wastewater by Ye et al.[42] These values are very low compared to the levels determined in this study.