The government review of clinical trial practise involved 1,622 programs of new pharmaceutical drugs waiting upon government approval to begin mass production. According to the report, the data gathered during the clinical trials failed to meet analysis requirements, were incomplete or were untraceable.
The SFDA report concluded that some of the companies involved were thought to have hidden or deleted records of potential adverse effects and tampered with the data that did not meet projections. As a result, more than 80% of applications for mass productions of newly developed drugs have been cancelled.
Though the extent of the scandal may be surprising, there has long been an awareness of issues within China’s pharmaceutical practises. Third party agencies that are tasked with inspecting facilities, known as contract research organisation, are quoted by the report as being “accomplices in data fabrication due to cutthroat competition and economic motivation”.
Es bueno recordar...:
"Las economías emergentes ofrecen, asimismo, oportunidades para mejorar los procesos de innovación a costes altamente competitivos, sobre la base de personal científico e investigadores muy competentes, formados en su mayoría en centros de excelencia investigadora de EEUU y Europa.
Esta oferta altamente cualificada está en el origen de lo que se denomina "off-shoring" o "externalización global", es decir la externalización de un número de operaciones de alto valor añadido, a proveedores situados en los mercados emergentes, en condiciones más atractivas y competitivas que las que ofrecen los especialistas y proveedores occidentales. China, India, Singapur y el este de Europa entre otros, son ejemplos claros de países emergentes que han priorizado el desarrollo de "Clusters" biotecnológicos de alta competitividad, donde se ofrecen servicios de I+D del más alto nivel científico, con compromisos óptimos de tiempos de ejecución y a unos costos muy por debajo de los existentes en los países desarrollados." La coincidencia en el espacio y en el tiempo de altos niveles tecnológicos, junto a bajos costes operativos es la causante de un desplazamiento histórico de riqueza y valor, desde el rico occidente al este emergente."
Del "off-shoring" en investigación clínica y/o el "deconstruir*" la "Doctrina Acebillo..."
The root of the issue is then not regulation, with regulation for clinical trials running on similar lines to Western practises, but in the lack of adherence to them. China’s generic drug industry has struggled with quality problems and therefore there is a temptation for companies to manipulate data to meet standards.
The report found that many of the new drugs were found to be a combination of existing drugs, with clinical trials outcomes written beforehand and the data tweaked to fit in with the desire outcomes.
Ben Hargreaves
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