Refer Report
During an audit by the National Assembly Health and Welfare Committee, suspicions were raised that PCL, a domestic diagnostic company, manipulated clinical trials for COVID-19 diagnostic kits. In response to this, PCL countered, saying, “It is not true at all,” and “This government audit is abusing normal corporate activities as a material for political attacks.”
On the 23rd, Kang Seon-woo, a member of the Democratic Party of Korea and the opposition secretary of the Welfare Committee, detected circumstances in which PCL manipulated clinical trial results in the process of developing a COVID-19 self-diagnosis kit using saliva during a national inspection of the Ministry of Food and Drug Safety. claimed to have done so.
Rep. Kang said, “PCL applied for permission from the Ministry of Food and Drug Safety for a COVID-19 self-diagnosis kit, but was judged unsuitable,” and added, “Then, they voluntarily withdrew their application for permission and immediately completed a clinical trial in 4 days through a medical foundation to obtain permission. “I reapplied,” he said. He continued, “(PCL) received approval after only 28 days of review,” and pointed out, “It’s amazing timing and a scenario like a movie.”
Representative Kang also presented an edited version of PCL CEO Kim So-yeon’s phone call recording as circumstantial evidence of clinical manipulation. The recording said, “We have conducted clinical trials on 1,000 people, but it is not easy to do it all at once. Remarks such as “It costs a lot of money,” and “If we want to silence both sides and the nurses here, we have no choice but to use money.”
At the same time, Representative Kang also raised suspicions that Representative Kim So-yeon received preferential treatment by taking advantage of her close relationship with President Yoon Seok-yeol and his wife. The stock price also soared after news broke that the kit would be supplied to President Yoon’s inauguration ceremony immediately after receiving approval from the Ministry of Food and Drug Safety.
In response to this, PCL posted a statement on the 24th, one day after the suspicions were raised, titled “The suspicions raised in this government audit are not true at all.”
PCL said, “The COVID-19 saliva self-diagnosis kit was clinically tested at the Samkwang Medical Foundation through the normal process,” adding, “In addition, the kit had already secured European certification through clinical trials in Morocco even before domestic approval, and was exported to major overseas countries.” “It is a product whose performance evaluation has been verified,” he said.
Regarding the edited version of the recording released during the National Assembly inspection, “CEO Kim expressed his personal gratitude for introducing the clinical specimen implementation institution to his university senior,” and added, “Some expressions that appeared in the recording were distorted and released as a result of several parts being stitched together. “He claimed.
He went on to emphasize, “It was just a misunderstanding that arose in the process of comfortably expressing to a close senior that the cost of collecting samples was excessive and costing a lot of money, and I was not referring to anything illegal.”
Minister of Food and Drug Safety Oh Yoo-kyung, who appeared before the National Assembly inspection on the 23rd, responded that she understands that the Ministry of Food and Drug Safety requested the Seoul Eastern District Prosecutors’ Office to investigate related matters in December of last year, and that the investigation was transferred to Songpa Police Station in January of this year. In response to this, PCL said, “We have not received any notification from the investigative agency at this time,” and added, “This government audit began with malicious and distorted editing and information by a specific informant, and normal corporate activities were abused as material for political attacks. “There is,” he said.
Reporter Nam Jeong-min peux@hankyung.com
Source: korean