Annas G J, Elias S
Health Law Department, Boston University School of Public Health, MA 02118-2526, USA.
Am J Public Health. 1999 Jan;89(1):98-101. doi: 10.2105/ajph.89.1.98.
The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the market. New laws regarding abortion and a new technology, ultrasound, make reasonable the approval of thalidomide for patients who suffer from serious conditions it can alleviate. In addition, the FDA and the manufacturer have proposed the most stringent postmarketing monitoring ever used for a prescription drug, including counseling, contraception, and ultrasonography in the event of pregnancy. The Titanic/thalidomide lesson for the FDA and public health is that rules and guidelines alone are not sufficient to guarantee safety. Continuous vigilance will be required to ensure that all reasonable postmarketing monitoring steps are actually taken to avoid predictable and preventable teratogenic disasters.
泰坦尼克号已成为一个象征，代表了对新技术的安全性和无敌性盲目信任所带来的灾难性后果。同样，沙利度胺悲剧代表了现代医学可能无意中或因疏忽而制造出的所有“怪物”。沙利度胺曾被禁用，随着美国食品药品监督管理局（FDA）宣布沙利度胺将上市用于治疗麻风结节性红斑（一种严重的麻风病皮肤并发症），它又重新成为争议的焦点。尽管这一适应症非常有限，但沙利度胺一旦上市将可用于标签外用途。关于堕胎的新法律和一项新技术——超声波检查，使得批准沙利度胺用于患有它能缓解的严重疾病的患者变得合理。此外，FDA和制造商提议对一种处方药采用有史以来最严格的上市后监测措施，包括咨询、避孕以及怀孕时进行超声检查。泰坦尼克号/沙利度胺事件给FDA和公共卫生带来的教训是，仅靠规则和指南不足以确保安全。需要持续保持警惕，以确保切实采取所有合理的上市后监测措施，避免可预见和可预防的致畸灾难。
