Core Viewpoint - The article discusses the investigation into the use of clinical research anti-cancer drugs by two patients in Chongqing, highlighting the actions taken by health authorities and the implications for medical practices and drug distribution in the region [1]. Group 1: Basic Situation - Patient Li was diagnosed with cervical cancer in June 2013 and underwent surgery, later receiving treatment at Chongqing University Cancer Hospital. In August 2023, her condition relapsed, leading to the recommendation of the drug Cadonilimab by her doctor [2]. - Patient Tang was diagnosed with cervical cancer in June 2017 and also underwent surgery. In January 2024, she was recommended to use Cadonilimab after her condition relapsed [2]. Group 2: Investigation and Handling - The investigation revealed that the doctor recommended Cadonilimab to both patients, which was a legitimate treatment option according to clinical guidelines. However, the doctor also violated ethical guidelines by recommending a sales representative to the patients [3][5]. - The investigation found that the doctor had informed the patients about potential risks associated with the drug, which has a 1.7% incidence of immune-related pneumonia [4][5]. Group 3: Drug Acquisition - Cadonilimab was approved for sale in June 2022 at a price of 13,220 yuan per unit. Patients could obtain it through self-purchase, charity programs, or clinical trials. Both patients acquired the drug through a combination of self-purchase and free clinical research supplies [6][7]. - The drug was included in the national medical insurance directory as of January 2025, reducing the out-of-pocket cost for patients to between 300 and 1,000 yuan per unit [7]. Group 4: Clinical Research Drug Sources - The investigation revealed that the clinical research drugs obtained by the patients were improperly sourced, with evidence of forgery by sales personnel from the drug company to acquire these drugs [8]. - The pharmacies involved were found to be in violation of drug management regulations by storing and distributing clinical research drugs without proper authorization [9]. Group 5: Drug Quality Verification - The drugs used by the patients were confirmed to be produced according to national standards, and no quality issues were found with the Cadonilimab they received [10]. Group 6: Investigation of Clinics - The clinic where the patients received treatment was found to have engaged in improper practices, including the use of forged prescriptions. The clinic faced penalties and was ordered to rectify its practices [11]. - Following the incident, health authorities initiated a comprehensive review of medical quality and ethical standards to prevent similar occurrences in the future [11].
重庆通报2名患者使用临床研究抗癌药调查核实情况