Reputational damageThe Ministry of Food and Drug Safety revoked a license for the gene therapy drug Invossa on Tuesday, reviving memories of the 2004 disgrace of cloning expert Hwang Woo-suk, who faked his own research. The ministry canceled the 2017 license to market Invossa, the first drug in the world to use gene therapy to treat knee osteoarthritis. The agency found that Kolon Life Science falsely reported the cell line was of cartilage rather than a kidney. The ministry filed a criminal complaint against the company for violating the Pharmaceutical Affair Act by producing and selling drugs that do not match the licensed version.
The decision stunned patients who paid 7 million won ($5,885) per shot for the knee therapy. About 244 patients who were injected with Invossa immediately filed a class action suit. The website receiving applicants for the lawsuit is brimming with angry posts. “I cannot express my frustration and anger, having received the treatment twice.” The lawsuit could cost the company tens of millions of dollars as 3,707 people received the injections in Korea.
Safety is the key to any drug. This drug was sold while keeping the authorities and patients in the dark about the errant cell line used to make it. Korea’s drug screening and supervisory system is in question. The government must examine the patients immediately to make sure they are all right.
The company’s management cannot be forgiven if it knew of such a fundamental problem. Even in light of Korea’s penchant for expeditiousness, haste in drug-making cannot be pardoned. The moral hazard could pose a serious stumbling block to our bio industry.
The United States, Japan, Germany and Switzerland became drug powerhouses through a century-old history. Korea is a relative newcomer to the industry. Kolon invested 110 billion won to develop Invossa over 19 years. But overeagerness and recklessness are harming the reputation of Korean drugs. Hanmi Pharmaceutical had to halt development of a lung cancer treatment because a multinational company canceled the $730 million deal after patient deaths. The hype over Cynanchum wilfordii as a safe herbal treatment for menopause fell victim to questionable ingredients.
Bio engineering is under state sponsorship. The government announced 4 trillion won funding to promote the bio industry. The move to deregulate should not be affected by the Invossa scandal. The industry and authorities must learn and become more thorough in both development and oversight.