A lawmaker and civic groups urged the government to nullify the license of Invossa-K, an osteoarthritis gene therapy developed by Kolon Life Science and Kolon TissueGene, to protect patients’ safety. They also called for an active investigation into the mislabeling of Invossa’s cell ingredient.
Rep. Youn So-ha of the minor opposition Justice Party, who is a member of the National Assembly’s Health and Welfare Committee, and civic groups held a news conference at the National Assembly to demand the government conduct a thorough probe and prepare practical measures to help patients treated with Invossa. The news conference on Tuesday marked the 50th day since Kolon revealed that it had been mislabeling one of the drug ingredients of Invossa over a decade.
|Rep. Youn So-ha (third from left) of the Justice Party speaks during a news conference at the National Assembly on Tuesday, calling for the government’s thorough investigation into the mislabeling of a drug ingredient of Invossa, developed by Kolon Life Science and Kolon TissueGene.|
Activist groups that joined the press conference are People’s Solidarity for Participatory Democracy, Center for Health and Social Change, and Association of Physicians for Humanism.
Demands of Youn and the three groups include the immediate revocation of Invossa approval, the prosecution’s active investigation on Kolon and the Ministry of Food and Drug Safety (MFDS), the return of the public funds for Invossa development, a government’s survey on all of the patients treated with Invossa neither by the MFDS nor Kolon, and discontinuation of a push for a bill aimed to support advanced regenerative medicine and high-tech biopharmaceuticals.
“It has been 50 days since Invossa sales have been suspended in March due to the mislabeled drug ingredient, but a government-level investigation is not working properly,” Youn said.
The government has failed to identify why the cell ingredient was kidney-derived, not cartilage-derived. The government does not have basic knowledge about these cells – not knowing their genetic traits, and whether the cells are safe in a human body, Youn added.
The lawmaker said the MFDS already had 50 days and only a week was left for them to release the outcome of its investigation. “I don’t think the MFDS can take care of this issue anymore. If their investigation gets nowhere and produces no meaningful outcome, the Moon Jae-in government will be held accountable,” he warned.
Youn said he did not have much expectation for the MFDS’ inspection of Kolon TissueGene in the U.S. this week.
The issue involves many problems that not only include the company’s wrongdoings but the regulator’s poor approval system. So, the prosecution should raid the companies for a swift and thorough probe,” he added.
Jeong Hyeong-joon, secretary general of the Association of Physicians for Humanism, said the Ministry of Health and Welfare was negligent of safety management.
“More than 3,700 people have received dangerous medications, but the health and welfare ministry did not engage in the issue at all and regarded the matter as if the MFDS and Kolon had to solve every problem,” Jeong said. “As the government promised that it would put the public lives and safety as top priorities, the government should collaborate with related institutions to conduct a follow-up on the patients.”
Kim Byeong-soo, a professor at Sungkonghoe University, demanded a detailed analysis of how the cells have been replaced from a scientific point of view.
“The key of the investigation is to find not when the cells were changed but if they ever existed in the first place. They need to identify whether Kolon’s so-called transduced cartilage-derived cells existed. Before Kolon tries to destroy or tamper with evidence, the prosecution should quickly raid the company,” he said.
Youn also called for a parliamentary hearing on the Invossa case, saying “the National Assembly should investigate the entire 17-year history of Invossa fraud.”