"Vomiting Blood and Enlarged Lungs" Shocking Results: Hidden Data Led to Approval, Subjecting 93 People to "Human Experimentation"

Although animal testing showed hamsters dying, vomiting blood, and suffering from severe pulmonary hypertrophy, a COVID-19 treatment that received clinical trial approval using data omitting these facts was confirmed to have been administered to 93 actual patients.

This treatment is the very drug by Genencell, which recently raised suspicions of lobbying after it was revealed that Justice Minister nominee Kim Seung-won requested the Ministry of Food and Drug Safety for expedited clinical trial approval.

According to data received from the Ministry of Food and Drug Safety by the office of People Power Party lawmaker Yoon Sang-hyun, Genencell's COVID-19 treatment ES16001 was actually administered to 93 trial participants during domestic Phase 2 clinical trials in 2022.

This treatment was originally developed as a candidate substance for a shingles treatment.

Genencell conducted non-clinical trials in 2021 using COVID-19-infected hamsters to develop it as a COVID-19 treatment.

However, out of five hamsters in the high-dose administration group, one showed symptoms of drug regurgitation and vomiting blood before dying, and severe pulmonary hypertrophy was observed even in the surviving subjects.

It was also reported that the efficacy as a treatment was not verified.

However, these details were deleted or omitted from the report submitted by Genencell when it applied to the Ministry of Food and Drug Safety for Phase 2 clinical trial approval.

This was also confirmed in the first-instance sentencing of Professor Kang, the founder of Genencell, for violating the Pharmaceutical Affairs Act.

The court ruled that Professor Kang instructeding the deletion of the information to secure approval, knowing that the fact of the hamster's death could adversely affect the clinical trial approval.

The problem is that the Ministry of Food and Drug Safety did not immediately approve Genencell's clinical trial application at the time.

Genencell initially attempted to proceed directly to Phase 3 trials in South Korea based on Phase 2 trials previously conducted in India, but the ministry did not accept this, telling them to reapply starting from Phase 2 and demanding additional animal testing data.

While approval was being withheld during this process, investigations showed that Professor Kang asked then-lawmaker Kim Seung-won for expedited approval through a broker surnamed Yang.

On October 12, 2021, nominee Kim asked then-Ministry of Food and Drug Safety Chief Kim Gang-lip, stating that Genencell had applied for clinical trials for a COVID-19 treatment and asking him to "take good care of it."

And 14 days later, on October 26, the clinical trials were approved.

It has now been revealed that the approved treatment was not limited to recruiting clinical trial participants but was actually administered to 93 patients. Meanwhile, the Ministry of Food and Drug Safety stated that no serious and unexpected suspected adverse drug reactions were reported from them.

Reported by Kim Minjeong | Video by Ahn Jun-hyeok | Graphics by Yook Do-hyun | Produced by SBS Digital News
※ Please note: This article was translated by AI and may contain errors.