114. The Fungus (New England Compounding Center)
2024/8/4
Swindled
G
George Carey
J
Joyce Lovelace
受
受害者
无
无特定发言人
Caprice Bearden: 坚称Pharmacon公司最近的药物测试结果符合规范，否认存在问题。
Paul J. Elmer: 声称任何有问题的测试结果都会被标记出来供他审查，试图推卸责任。
Josh Minkler: 指控Pharmacon公司多次被告知其生产的药物药效与标签不符，但他们却置之不理，将利润置于患者安全之上。
Barry Cadden: 在听证会上行使宪法第五修正案权利，拒绝回答问题，并在审判中否认自己对药物污染事件负有责任。
Glenn Chin: 对下属的提醒表示轻蔑，对公司的卫生问题视而不见。
Deval Patrick: 宣布吊销NECC的营业执照，强调对相关责任人的严厉处罚。
Gregory Conigliaro: 指出NECC公司为了追求利润而忽视了安全，最终导致病人受伤。
Joe Connolly: 揭露Barry Cadden看到了药品短缺带来的利润机会。
Margaret Hamburg: 承认FDA对配方药房的监管权限不明确，呼吁加强监管。
Richard Blumenthal: 批评配方药房陷入了监管黑洞。
Joyce Lovelace: 痛诉这场悲剧给她的家庭带来的巨大痛苦，并呼吁政府采取措施防止类似事件再次发生。
George Carey: 认为这场悲剧应该促使政府加强监管，防止类似事件再次发生。
Caprice Bearden: Bearden told FDA investigators that none of the company's recent test results for the drug were out of specification.
Paul J. Elmer: Paul J. Elmer, Pharmacon's owner and chief executive, concurred. He told the FDA that any concerning results would have been flagged for his review.
Josh Minkler: As alleged in this indictment, not one time, not two times, not even three times, but 70 times, the defendants were told that the drugs they were making were weaker or stronger than what the label on the drug said.
Barry Cadden: On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the United States Constitution.
Glenn Chin: "Fuck off," wrote supervising pharmacist Glenn Chin in response to Annette Robinson's reminder that new pharmacists shouldn't be allowed to compound drugs without first having performed competency tests.
Deval Patrick: Those whose laboratory practices caused this outbreak should never practice pharmacy or manufacture in Massachusetts again.
Gregory Conigliaro: The underlying factor is that the company got greedy and overextended and we got sloppy and something happened.
Joe Connolly: I think Barry was, he saw with the shortage drugs and the volume that we were putting out on those, I think he saw that there was money to be made.
Margaret Hamburg: Commissioner Hamburg argued that the FDA's authority over compounding pharmacies was unclear.
Richard Blumenthal: fall into a regulatory black hole.
Joyce Lovelace: My family is bitter. We are angry. We're heartbroken. We're devastated. And I just come here begging you to do something about the matter.
George Carey: Our loss and that of others should be a wake-up call to our country.
Deep Dive
Pharmacon Pharmaceuticals, a compounding pharmacy, faced a series of incidents where overly potent medications were distributed, leading to serious health issues and a subsequent FDA investigation.
Shownotes Transcript