PCL, a South Korean diagnostic kit company, is under scrutiny following allegations of manipulating clinical trials for its saliva-based COVID-19 self-testing kit. The accusations surfaced during a National Assembly audit, prompting an investigation into potential misconduct and regulatory favoritism.
Allegations of Data Fabrication and Undue Influence
Rep. Kang Sun-woo of the Democratic Party of Korea accused PCL of fabricating clinical trial results for its COVID-19 self-test kit. Kang highlighted that PCL initially faced rejection for its test kit, withdrew the application, and then rapidly completed clinical trials in just four days before reapplying. Approval was granted within 28 days, coinciding with PCL's announcement of supplying test kits for President Yoon Suk Yeol’s inauguration, fueling suspicions of preferential treatment.
Kang further alleged that PCL CEO Kim So-yeon used connections with President Yoon and his wife to expedite the approval process, raising concerns about potential favoritism in the regulatory process.
Evidence Presented During the Audit
During the audit, Rep. Kang presented a recording of discussions between PCL and Samkwang Medical Foundation, the institution responsible for conducting the clinical trials. In the recording, a voice purportedly belonging to CEO Kim discusses securing the clinical trials with Samkwang despite concerns about the foundation’s reputation, stating, "Samkwang has some risks, but I got them business deals, so they’re happy with us."
The recording also contains allegations of financial incentives to nurses involved in the testing process to ensure their silence about the falsified trials. "If we want to keep the nurses quiet [about the falsified trials], we’ll have to pay them," the voice states. The recording further suggests that Samkwang signed off on clinical trial reports without actually conducting the trials, indicating potential scientific misconduct.
Regulatory Response and Potential Penalties
MFDS Minister Oh Yu-kyoung confirmed that an investigation is underway. If the allegations are substantiated, PCL’s test kit approval 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). The case has been referred to the Seoul Eastern District Prosecutors' Office and subsequently transferred to the Songpa Police Station.
PCL's Defense
PCL has vehemently denied all allegations of clinical trial manipulation. In an official statement, the company asserted that it followed the appropriate approval process, as confirmed by the MFDS during the audit. PCL stated that the clinical trials were conducted by Samkwang Medical Foundation through a legitimate process in 2022, with performance evaluations including sensitivity and specificity tests using clinical specimens from patients at a designated hospital. These samples were compared to nasopharyngeal PCR tests, and the clinical trial reports were compiled by Samkwang Medical Foundation.
PCL also addressed accusations of preferential treatment, emphasizing that its product had already undergone performance evaluations in Morocco and obtained European certification before applying for approval in Korea. The company clarified that the clinical trials conducted in Morocco did not meet MFDS standards, necessitating additional trials through a certified Korean clinical institution.
Market Impact
Despite PCL's denial, the allegations have significantly impacted the company's stock price, which plummeted on Thursday following the audit revelations.
