Professor at Suffolk University Law School and a Lab Fellow at the Edmond J. Safra Center for Ethics at Harvard University.
J Law Med Ethics. 2013 Fall;41(3):581-9. doi: 10.1111/jlme.12067.
Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies.
不当的依赖关系使药物的生命周期中的政策产生偏差，从而影响新药的开发、新药的测试和市场批准，以及药物上市后的患者安全监测。本文探讨了公众不当依赖制药公司的五种方式，这些方式损害了药物政策的完整性。如今，公众依赖制药公司：（1）确定药物研究和开发的优先事项；（2）进行临床试验以测试药物是否安全有效；（3）决定向公众披露哪些临床试验数据；（4）监测药物上市后的安全性；（5）向医生提供产品信息，并为继续教育和其他专业活动提供资金。本文提出了克服这些依赖关系的选择方案。
