The Ministry of Food and Drug Safety has come under criticism for doing little on more than 300 side effects reported regarding Invossa-K, Kolon Life Science’s controversial osteoarthritis gene therapy, including even eight tumor cases.
According to ministry data, there were 329 cases of adverse effects of the drug reported from Jan. 1, 2014 to Aug. 11, 2018. They included eight cases of tumor-related abnormalities -- malignant endometrial neoplasia and gastric carcinoma report, pancreatic cancer, liver neoplasm, female malignant breast neoplasm, and secondary carcinoma.
There were also 63 reports claiming the drug was ineffective, nearly twice higher than other osteoarthritis treatments, according to the ministry’s report submitted to Rep. Cheong Chun-sook of the ruling Democratic Party of Korea.
A bigger problem, however, was the regulatory agency did not even bother to conduct an epidemiological survey of the eight tumor cases, Rep. Chung said in a press release.
According to her office that checked the ministry’s reaction to the tumor-related side effects, the regulator concluded those side effects had little relationship with the drug, or the ministry could not assess the relationship. “Therefore, we have not conducted an epidemiological investigation so far,” the ministry was quoted as saying by the lawmaker’s office.
"While the situation is so serious, the ministry seems to have stood by idly, doing little to protect the safety of the public," Chung said.
"To date, most experts believe that Invossa-K has no major concerns when considering toxicological data and irradiation at the time of licensing," she said. “However, proper management such as the registration of patients and long-term follow-up for up to 15 years is necessary because kidney cells used in the treatment are cancer-prone, but the ministry was negligent.”
In response, the ministry said it plans to perform a series of tests on patients who have completed their first enrollment, this month. “The first registered patients will be tested within this year,” the agency said.
Kolon Tissuegene, which developed Invossa, had boasted it as the world's first osteoarthritic cell gene therapy. While the company believed that the drug's component, comprised of human chondrocytes (HC, 75 percent) and transformed cells (TC, 25 percent), all derived from cartilage, it was later found out that TCs were HEK 293 cells, derived from the kidneys in April of this year.
Kolon Life Science discovered the mislabeling after a voluntary STR testing, often used for paternity testing. STR testing demonstrates specific profiles of cells through genetic test analysis. The 293 cells are noticeably different from healthy cells in the speed of proliferation, and the expressions as the former proliferate indefinitely just like cancer cells.
Soon after, the ministry revoked the sales approval for Invossa-K after confirming that the company had manipulated the data submitted during the application process. Kolon is currently waging a court battle with the ministry to keep the drug alive.