An activist physician claimed that Invossa-K, recently suspended gene therapy by Kolon Life Science, could win domestic license because of the government and politicians’ pro-business policies and support.
He called for a thorough investigation by the prosecution and a special state audit.
|Jeong Hyeong-joon (third from right), secretary general of the Association of Physicians for Humanism (APH), speaks at a debate on what was the real problem in the mislabeling of gene therapy Invossa-K, at the National Assembly, on Friday.|
Jeong Hyeong-joon, secretary general of the Association of Physicians for Humanism (APH), called the mislabeling of the drug ingredient of Invossa “Invossagate,” urging the prosecutors’ probe, at a debate on what was the real problem in the Invossa debacle. Rep. Yoon So-ha of the progressive Justice Party organized the debate on Friday.
Earlier, the Ministry of Food and Drug Safety analyzed the drug ingredients including the working cell bank and confirmed that the second ingredient of Invossa was revealed to have been GP2-293 cells, not cartilage-derived cells as described in the data submitted to the regulator’s approval in 2017.
Neither the ministry nor the company had fully clarified why 293 cells were mixed in the drug, when it occurred, and whether the company intentionally did it.
In 1998, Inha University Professor Lee Kwan-hee started studies to develop Invossa, with the support of the public health technology research program of the Ministry of Health and Welfare. At every study stage, the drug candidate garnered the state support by winning the major government programs run under the health and welfare ministry, the Ministry of Knowledge Economy, and the Ministry of Science and ICT.
After Rep. Park In-sook of the formerly Saenuri Party proposed a revision bill to the Bioethics and Safety Act, the law was eased in December 2015 to allow phase-3 trials on Invossa.
Jeong said the health authorities had not conducted thorough verification on the Invossa’s research, although the medicine has spent 40 billion won ($34.4 million) R&D cost in total.
While Invossa was not eligible for review on biological agent licensing, the regulator approved a review on the drug in just two months, Jeong claimed.
“At that time, I wondered why a new Article (easing the standard for approval for clinical trials on gene therapies) was inserted in the revision bill. Invossa is the only drug that matched this Article,” Jeong said. “Trials on Invossa were Okayed through this.”
Jeong mentioned a minute from the Ministry of Food and Drug Safety (MFDS)’s central pharmaceutical affairs advisory committee in April 2017 when the regulator first gave the green light to Invossa.
“According to the minute, six out of the seven panelists said it was inappropriate to take the risk of gene therapy, just for symptom relief, when the efficacy was unclear,” he said. “As soon as Food and Drug Safety Minister Ryu Young-jin took office, however, the committee allowed Invossa to be reviewed for approval in the second committee meeting in July.”
Jeong also noted how Kolon was able to obtain Invossa license based on a study that compared the drug with saline (placebo), not with the standard treatment using hyaluronic acid.
“I have a reasonable suspicion that Kolon Life Science might have been lobbying for clinical trials and approval procedures,” Jeong said, signaling possible collusion between the government and the biotech firm.
Several officials of the company must have raked in an enormous amount of benefits thanks to Invossa sales, along with the initial public offering of Kolon TissueGene, Jeong said.
In contrast, patients treated with Invossa and Korean taxpayers suffered damages including the massive state spending, he emphasized.
“We should mobilize all kinds of measures such as an audit by the Board of Audit and Inspection, an investigation by the prosecution, and a parliamentary audit, to track down how this money was spent,” Jeong added.