The problem is not the trial. The problem was an out of order early approval after only a phase two trial with very weak evidence. The phase three trial of cour

The problem is not the trial. The problem was an out of order early approval after only a phase two trial with very weak evidence. The phase three trial of course would go on even without such an out-of-order approval. The false hope such an approval creates doesn’t just affect patients directly. It may lead other companies to abandon or slow down therapies that might have competed in this indication. Approval of a drug is a huge deal. Perhaps eventually our drug approval system will change, but right now approval gives a company the power to market a drug to doctors, and doctors can prescribe it to patients, patients can ask for it, insurers cover it, and so on… This one was a conditional approval and the condition failed, which means the system still works, however it now has a possible loophole for how to bootstrap a pharma company. It is not clear yet if that loophole may increase human suffering on average, or not, and it likely depends on how the companies that take advantage of such a loophole grow. Drug discovery, design, and development are capital intensive operations and suffer from lack of innovation, but they also attract greedy people at the executive level who don’t bring therapeutic innovations to the table but rather find out how to draw investor money.