The government invested 8.21 billion won ($6.9 million) in healthcare-related research institutes to help Kolon Life Science develop Invossa-K between 2015 and 2018. Still, the institutes’ studies were too poor to discover the mislabeling of the drug’s ingredient, a lawmaker said.
|Kwon Deok-cheol, director of Korea Health Industry Development Institute, prepares his answers during the parliamentary audit on Tuesday.|
Rep. Jung Choun-sook of the ruling Democratic Party disclosed how the government money was spent on Invossa research, at an audit by the National Assembly’s Health and Welfare Committee on Tuesday.
The 8.2 billion won R&D spending support for Kolon Life Science was divided into five sub-tasks. However, most of the research programs were unsatisfactory, according to the results of the on-site inspection of the Korea Health Industry Development Institute (KHIDI).
The first research program for Kolon aimed at “analyzing characteristics of genetically modified cartilage cells.” However, after Kolon said such analysis was unnecessary, KHIDI changed the purpose of the research to “analyzing characteristics of normal cells.” The institute lost the opportunity to identify the risks of transduced cells in the second fluid of Invossa.
Before the change, the research plan stated, “This study aims to verify the cells by analyzing characteristics of transduced cartilage cells and donors’ cartilage cells, to predict the safety, stability, and efficacy of the cell gene therapy.” However, the institute did not carry out the study as planned.
“If KHIDI had analyzed the transduced cells of the second fluid of Invossa as planned, it would have discovered that normal cartilage cells and transduced cells were different,” Jung said, citing experts’ comments.
The third study’s goal was “to develop a system to mass-cultivate cartilage cells.” Still, the institute did not perform the characterization of cultured cells clearly, which made it difficult to judge whether the final selection of the cells was optimal.
Although KHIDI properly conducted the fourth research to develop an arthroscopic treatment technology for Invossa to treat degenerative osteoarthritis, the research notes did not conform to the principles of writing, and the explanations for experimental methods, lab materials, and concrete results were insufficient.
The institute used Invossa for the study but did not analyze the properties and characteristics of the second fluid separately.
The Ministry of Health and Welfare and KHIDI conducted an interim assessment for the first year in July 2016, but the evaluation did not have much substance, Jung said.
She called for enhancing the evaluation system for the national R&D projects that use taxpayers’ money.
KHIDI Director Kwon Deok-cheol said, “In retrospect, there were some insufficient efforts. I will designate a professional reviewer for each of the sub-projects of the large national projects to see if they are properly handled.”
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