Producer slammed for false reporting of ingredient
The Ministry of Food and Drug Safety has revoked the license for the gene therapy drug Invossa after the manufacturer falsely reported an ingredient change. The revocation is a necessary step to kick the flawed medicine from the market. But it is far from sufficient to ensure the country's drug safety system works properly.
Aside from canceling the license Tuesday, the regulator requested law enforcement authorities to conduct a criminal investigation to get to the bottom of the Invossa scandal. The action came after the ministry suspended the distribution of the drug in March when the maker, Kolon Life Science, acknowledged that a material used in Invossa came from kidney cells instead of cartilage.
The ministry has finally confirmed the use of the wrong ingredient after conducting an investigation. It claimed Kolon had falsely reported the ingredient when it received approval for the drug in July 2017, despite knowing about the use of kidney cells instead. The manufacturer denied the claim, saying that it had been unaware of the ingredient change until early this year.
Kolon seems to have lied about the case. If the firm is found to have concealed the truth about the wrong material, it may face criminal charges. Such false report should not be condoned because it could cause unpredictable consequences to patients. This explains why biopharmaceutical companies are required to follow safety regulations faithfully.
Kolon cannot evade responsibility for the Invossa case. An allegation has it that the company presented falsified documents to the drug regulator in July 2016 when applying for the license for the new medicine. If the allegation turns out true, the firm should be held accountable for its cover-up attempt.
The case is reminiscent of a veterinary professor and cloning expert, Dr. Hwang Woo-suk, who was found to have faked his embryonic stem cell research data in 2004. Hwang shocked the nation as his disregard for research ethics brought himself disgrace, undermining the entire country's credibility.
Invossa is the first gene therapy drug in the world to treat osteoarthritis which causes joint pain in the elderly. The number of osteoarthritis patients is estimated at 5 million. About 3,700 patients have so far used Invossa by paying 7 million won ($5,850) for a one-time treatment. This means they received the highly expensive injection treatment for up to 20 months without knowing about the misreported ingredient.
Frustrated and angry about the case, 244 patients filed a suit against Kolon, seeking 2.5 billion won in damages. The drug safety ministry has promised to monitor all the patients for the next 15 years for possible side effects of the drug. It should keep the promise thoroughly to ensure their health.
The Invossa fiasco can be attributed to Kolon's relentless pursuit of profit. The firm must have neglected enhancing drug safety. Regulators and health authorities should take responsibility for not putting a tight safety system in place. Developing new drugs and beefing up the biopharmaceutical industry is important. But the country should not put people's health on the backburner. This is the lesson we have to learn from the case.
The Ministry of Food and Drug Safety has revoked the license for the gene therapy drug Invossa after the manufacturer falsely reported an ingredient change. The revocation is a necessary step to kick the flawed medicine from the market. But it is far from sufficient to ensure the country's drug safety system works properly.
Aside from canceling the license Tuesday, the regulator requested law enforcement authorities to conduct a criminal investigation to get to the bottom of the Invossa scandal. The action came after the ministry suspended the distribution of the drug in March when the maker, Kolon Life Science, acknowledged that a material used in Invossa came from kidney cells instead of cartilage.
The ministry has finally confirmed the use of the wrong ingredient after conducting an investigation. It claimed Kolon had falsely reported the ingredient when it received approval for the drug in July 2017, despite knowing about the use of kidney cells instead. The manufacturer denied the claim, saying that it had been unaware of the ingredient change until early this year.
Kolon seems to have lied about the case. If the firm is found to have concealed the truth about the wrong material, it may face criminal charges. Such false report should not be condoned because it could cause unpredictable consequences to patients. This explains why biopharmaceutical companies are required to follow safety regulations faithfully.
Kolon cannot evade responsibility for the Invossa case. An allegation has it that the company presented falsified documents to the drug regulator in July 2016 when applying for the license for the new medicine. If the allegation turns out true, the firm should be held accountable for its cover-up attempt.
The case is reminiscent of a veterinary professor and cloning expert, Dr. Hwang Woo-suk, who was found to have faked his embryonic stem cell research data in 2004. Hwang shocked the nation as his disregard for research ethics brought himself disgrace, undermining the entire country's credibility.
Invossa is the first gene therapy drug in the world to treat osteoarthritis which causes joint pain in the elderly. The number of osteoarthritis patients is estimated at 5 million. About 3,700 patients have so far used Invossa by paying 7 million won ($5,850) for a one-time treatment. This means they received the highly expensive injection treatment for up to 20 months without knowing about the misreported ingredient.
Frustrated and angry about the case, 244 patients filed a suit against Kolon, seeking 2.5 billion won in damages. The drug safety ministry has promised to monitor all the patients for the next 15 years for possible side effects of the drug. It should keep the promise thoroughly to ensure their health.
The Invossa fiasco can be attributed to Kolon's relentless pursuit of profit. The firm must have neglected enhancing drug safety. Regulators and health authorities should take responsibility for not putting a tight safety system in place. Developing new drugs and beefing up the biopharmaceutical industry is important. But the country should not put people's health on the backburner. This is the lesson we have to learn from the case.
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