The Clinical Trial Behind the "95% Treatment Efficacy": What Are the Facts?

[Anchor]

Nominee Kim Seung-won explained that the background behind forwarding a civil complaint to the Ministry of Food and Drug Safety was based on clinical trial results showing a 95% recovery rate among COVID-19 patients. However, it appears that the company's own data constituted virtually the entirety of the information, with insufficient verification from the academic community.

Reporter Han Sung-hee has the details.

[Reporter]

Regarding the background of why he filed a complaint with then-Ministry of Food and Drug Safety Chief Kim Gang-lip in October 2021, then-Minister of Justice nominee Kim Seung-won stated yesterday (the 7th):

[Kim Seung-won / Nominee for Minister of Justice : After reviewing the data upon hearing the complaint, my understanding was that phase 2 and phase 3 clinical trials for the product were already underway overseas, and there were report materials indicating the results were decent...]

He had previously stated, "I reviewed data showing that 95% of COVID-19 patients recovered."

At the time the complaint was forwarded, the data on the new drug from the pharmaceutical company Genencel consisted virtually entirely of a company notice released in December 2020 and a few media reports.

The content claimed that "the results of completing phase 2 clinical trials in India proved high efficacy, with over 95% of COVID-19 patients recovering, which is significantly superior compared to India's standard treatment showing an efficacy rate of about 68%."

However, the contents of the Indian clinical trial paper published in January 2022, three months after nominee Kim's complaint, were somewhat different.

The clinical research team divided 60 patients into two groups, administering "the new drug candidate along with standard treatment" to one group, and "a placebo along with standard treatment" to the other.

Patients took India's existing standard treatment alongside the new drug candidate.

The clinical research team noted that "conducting clinical trials with the new drug alone is a task to be done in the future."

A university hospital professor pointed out to SBS, "Even though superiority over the standard treatment was not proven for the new drug candidate, the company notice was written as if the two were directly compared, leaving a high possibility of misdirection."

This paper was a preprint—a preliminary paper that had not undergone peer review by fellow doctors—and no official paper has been published since.

Following nominee Kim's complaint to the Ministry of Food和 Drug Safety, Genencel founder Professor Kang sold 6.3 billion won worth of stock.

Regarding whether he was aware of the limitations of the data at the time, nominee Kim's side reaffirmed their previous response, stating, "The nominee is a non-expert in medicine and forwarded the complaint after checking the data indicating that 95% of patients recovered."

(Video reporting: Joo Yong-jin, Video editing: Kim Jun-hee, Design: Hwang Se-yeon)
※ Please note: This article was translated by AI and may contain errors.