Cardiovascular and Renal Drugs Committee Debates Hypertension Trial Designs and Labelling
I’m happy to report that science has prevailed in the debate over study designs that took place as part of Wednesday’s CRDAC meeting to discuss FDA’s draft guidance on studies and labeling for anti-hypertension drugs. In a nutshell, the advisors voted overwhwelmingly in favor of maintaining placebo-controls in a variety of hypertension superiority studies. They did so with the proviso that appropriate subject protections always be in place (i.e. “rescue” criteria). It’s gratifying to see that opinion leaders maintain a healthy respect for science in the face of growing pressures from alarmist industry-bashers to abandon it (in favor of restricting access to new drugs). Placebo controls (that is, direct comparisons with a placebo) remain the best way to control clinical tests of efficacy and safety of new drugs, in terms of accuracy and efficiency. Until or unless a better way is found, industry should maintain a voice in the debate on the side of science.
