Foreign osteoarthritis patients expressed fury over the mislabeling of ingredients of Invossa-K, now-suspended gene therapy by Kolon Life Science.
As they found out that the second fluid of the drug contained kidney-derived, cancerous cells called GP2-293 cells instead of cartilage-derived cells, they are seeking to join a class-action lawsuit against the Korean company. Law firm Oh Kims is gathering patients treated with Invossa for the class-action suit via an online platform, “Angry People.”
A British man living in Hong Kong sent an e-mail to Korea Biomedical Review saying he received Invossa treatment in Korea in November last year due to his knee arthritis. He became increasingly anxious after learning that Invossa contained cancerous cells.
“I would never in a million years have gone to South Korea for the injection had I known it was 293 cells,” the patient from Hong Kong said. “The company’s claim that radiation prevented a fatal problem, but this does not assure me at all. It’s like playing a game with 4,000 peoples’ lives.”
An American who participated in the phase-3 trial on Invossa in the U.S. said he got the injection two months ago in his right knee to treat osteoarthritis. “I’m terrified to learn that actual cancerous cells were put into my body without my knowledge,” he said in an e-mail.
He went on to say, “I am now terrified about the potential malignancy risks I have unwillingly been exposed to, which might manifest themselves years down the road, if not sooner.”
The American said he contacted a clinical director in charge of the phase-3 trial in the U.S., but she said she was “in the dark about everything as well.”
Both of the two foreign patients said they had trust in Invossa because the injection had been approved for sales in Korea and it was on a phase-3 test in the U.S. Shocked to learn that different cell ingredients have been sold all along, they said they would seek legal actions against Kolon.
The British patient said Kolon Life Science CEO Lee Woo-sok was “being defensive and not telling the truth.” “I want to join the class action lawsuit. I want the company to understand my fear and provide real answers.”
The U.S. patient also said he would like to join the class-action lawsuit.
Invossa had been promoted as the “world’s first” gene therapy for osteoarthritis, drawing keen attention from patients overseas. Some international patients, including the British one who e-mailed KBR, reportedly visited Korea for Invossa treatment.
However, foreign patients treated with Invossa in Korea had almost no access to direct information, neither from Kolon nor from hospitals. They have come to know the Invossa issue only through English news articles without any contact from hospitals.
Even though the Ministry of Food and Drug Safety (MFDS) said it would conduct a long-term follow-up on all of the 3,707 patients who had the knee injections, it is questionable whether monitoring of all foreign patients will be feasible.
KBR asked an official at the food and drug safety ministry how it would identify which foreign patients received Invossa injections in Korea and check on them. The official said he has “not thought about it, and the ministry was not able to fully identify the patient list because it was sending a public notice to hospitals.”
An official at Kolon Life Science said the company did not have any detailed information about foreign patients treated with Invossa because their medical records are kept separately by individual hospitals.
“We will have a plan to find about foreign patients through an agency. We will be able to do follow-ups at hospitals overseas,” the official said.
“If foreign patients are not afforded the same protections as Korean patients, then the MFDS’ reputation will suffer far worse, and confidence in Korean medicine will be lower than if they had just helped the few foreign patients,” the British patient said.