Dectin-1 deficiency and mucocutaneous fungal infections.

n engl j med 362;4 nejm.org january 28, 2010 367 (HAPO) study.3,4 Fifteen institutional review boards approved our protocol, and none rejected the trial on ethical grounds. In addition, an independent data and safety monitoring committee regularly reviewed the trial. Some participants would not even have met the criteria for gestational diabetes (more evidence of clinical equipoise). We strongly disagree with an assertion that we unnecessarily exposed participants to harm. Randomized trials are necessary provided that there is sufficient uncertainty and that the results will resolve the dispute among physicians, which was the case for the treatment of mild gestational diabetes.5 We agree that our results may encourage previously reluctant physicians to treat gestational diabetes, but such treatment is now supported by evidence from a clinical trial rather than by expert opinion alone.