Core Viewpoint - The investigation into the use of clinical research anti-cancer drugs by two patients in Chongqing has revealed significant issues regarding the recommendation and procurement of these medications, highlighting potential violations of medical ethics and regulations [1][5]. Group 1: Patient Cases - Patient Li was diagnosed with cervical cancer in June 2013 and underwent surgery, later receiving treatment at Chongqing University Cancer Hospital, where she was recommended to use the drug Cadonilimab after a positive PD-L1 test in August 2023 [2]. - Patient Tang was diagnosed with cervical cancer in June 2017 and, after a recurrence, was recommended to use Cadonilimab instead of the initially suggested Pembrolizumab due to cost considerations [2][4]. Group 2: Medical Professional Conduct - The investigation found that the doctor involved, referred to as Li, recommended Cadonilimab to both patients, which is within the scope of normal medical practice according to clinical guidelines [5]. - However, the doctor violated local regulations by recommending a sales representative to the patients, leading to disciplinary actions including warnings and suspension of prescription rights [5]. Group 3: Drug Procurement and Usage - Cadonilimab was approved for market sale on June 28, 2022, with a price of 13,220 yuan per unit, and patients could obtain it through various means, including self-purchase and charity programs [6][7]. - Both patients acquired a total of 70 and 90 units of the drug respectively, with a significant portion obtained through clinical research channels, raising concerns about the legitimacy of these sources [7]. Group 4: Clinical Research Drug Sources - The investigation revealed that the clinical research drugs obtained by the patients were marked as "for clinical research use" and were not part of any approved clinical trials at the hospitals involved [8][10]. - Sales personnel from the drug company were found to have forged documents to obtain these drugs, leading to regulatory scrutiny and potential legal consequences [8][9]. Group 5: Quality and Compliance of Drugs - The drugs used by the patients were confirmed to meet national quality standards, despite being labeled for clinical research, indicating compliance with production regulations [10][11]. - The investigation prompted a review of the management of clinical research drugs and the implementation of stricter regulations to prevent future violations [12].
2名患者使用临床研究抗癌药,官方通报!