PCL faces allegations of clinical trial manipulation for Covid-19 test kit
PCL, a Korean diagnostic kit company, is facing allegations of manipulating clinical trials for its saliva-based Covid-19 self-testing kit. The accusations were raised during a National Assembly audit on Wednesday, drawing significant attention due to the potential involvement of top-level executives and claims of undue influence.
During the audit, Rep. Kang Sun-woo of the main opposition Democratic Party of Korea accused PCL of fabricating the results of its clinical trials for the saliva-based Covid-19 self-test kit and called for a thorough investigation.
Kang’s remarks were directed at Oh Yu-kyoung, the Minister of the Ministry of Food and Drug Safety (MFDS).
The lawmaker pointed out that PCL had applied for approval of its test kit but initially received a unanimous rejection. The company then voluntarily withdrew its application the following day, only to complete the clinical trials in just four days and reapply for approval less than a month later.
Within 28 days, the MFDS granted approval for the kit. Coincidentally, PCL announced on its website that the test kits would be supplied for President Yoon Suk Yeol’s inauguration, fueling suspicions of preferential treatment.
Kang alleged that CEO Kim So-yeon used her connections with President Yoon and his wife to expedite the approval process. This raises serious concerns about potential favoritism in the regulatory process.
During the audit, Kang also released a recording involving discussions between PCL and Samkwang Medical Foundation, the institution responsible for the clinical trials.
In the recording, a voice believed to be CEO Kim explains how PCL managed to secure the clinical trials with Samkwang despite concerns about the foundation’s reputation. "Samkwang has some risks, but I got them business deals, so they’re happy with us,” the voice says.
Further into the recording, Kim allegedly discusses the financial burden of conducting the trials and mentions efforts to pay off nurses involved in the testing process.
"If we want to keep the nurses quiet [about the falsified trials], we’ll have to pay them," the voice states. The recording also mentions that Samkwang signed off on the clinical trial reports without actually conducting the trials, raising the possibility of serious scientific misconduct.
Rep. Kang emphasized that if Samkwang Medical Foundation did not actually perform the clinical trials but merely signed the documents, this is clearly a clinical trial manipulation case.
In response to the allegations, MFDS Minister Oh confirmed that an investigation was already underway. She acknowledged that if the claims are proven true, the approval for PCL’s test kits would be revoked, and the company could face penalties of up to five years in prison or fines up to 50 million won ($36,263).
Oh also revealed that the case was referred to the Seoul Eastern District Prosecutors' Office in December 2023 and later transferred to the Songpa Police Station in January 2024.
"We are working on ensuring the investigation proceeds swiftly," she said, while acknowledging that the MFDS lacks the resources to fully investigate the matter on its own.
Rep. Park Joo-min of the Democratic Party of Korea expressed concerns about the slow pace of the investigation, warning that any delays could lead to perceptions that the MFDS is intentionally overlooking the matter.
“Given the severity of the allegations, the investigation must be expedited to ensure accountability,” Park stated.
PCL's response to allegations
PCL has strongly denied all allegations of clinical trial manipulation that were raised during the National Assembly audit.
In an official statement released on Thursday, the company stressed that the allegations raised in the recent National Assembly audit are entirely false.
“PCL went through the appropriate approval process, as confirmed by the MFDS during the audit,” the company said.
The company explained that the clinical trials for its saliva-based Covid-19 test kit were conducted by Samkwang Medical Foundation through a legitimate process in 2022.
PCL clarified that the performance evaluation, which included sensitivity and specificity tests, was carried out with clinical specimens collected from patients at a designated hospital. The samples were compared to nasopharyngeal PCR tests, and the clinical trial reports were compiled by Samkwang Medical Foundation.
“Since the kit was intended for use by the general public, a separate evaluation was conducted at a hospital, where 100 participants completed questionnaires and tested the kits under supervision,” the company said. “The clinical trial results were prepared in compliance with MFDS guidelines and were submitted through the appropriate channels.”
Regarding accusations of preferential treatment in the kit approval process, PCL emphasized that its product had already undergone performance evaluations in Morocco and obtained European certification before applying for approval in Korea.
“Under Korean law, the clinical trials conducted in Morocco did not meet the standards required by the MFDS,” the company said. “Therefore, to sell the product in Korea, additional clinical trials were conducted through a certified Korean clinical institution.”
Based on the legitimate results of these trials, the product received approval from the MFDS, it added.
The company stressed that it did not receive any special privileges, nor conducted any illegal activities.
PCL concluded the statement by noting that it had not been notified of any formal investigation by authorities. However, the company pledged full cooperation should an inquiry proceed and plans to take action against individuals responsible for spreading false information, which they claim has harmed their business reputation.
Despite the company’s explanation, the allegations that came out during the audit made PCL’s shares plummet on Thursday.
As of 2:00 p.m., the company’s stock price stood at 825 won, down 21.35 percent from the previous trading day.