🔮Pre-Determining Clinical Endpoints Requires Psychic Powers

Current Regulation Expects Drug Developers to Have Psychic Powers Needed to Pre-Determine Very Specific Clinical Endpoints Before Collecting Data

When running an efficacy trial, the FDA expects that the drug developer has the psychic ability to predict which conditions a treatment will be most effective for in advance of collecting the human trial data. If it was possible to magically determine this without any trials, it would render efficacy trials completely pointless.

In 2007, manufacturer Dendreon submitted powerful evidence attesting to the safety and efficacy of its immunotherapy drug Provenge, which targets prostate cancer. They were able to show that the drug resulted in a significant decline in deaths among its study population, which even persuaded the FDA advisory committee to weigh in on the application. But ultimately, the FDA rejected its application.

The FDA was unmoved by the evidence, simply because Dendreon didn’t properly specify beforehand what its study was trying to measure. Efficacy regulations state that finding a decline in deaths is not enough. The mountains of paperwork must be filled out just so and in the correct order. It took three more years and yet another large trial before the FDA finally approved the life-saving medication.

Due to all the additional costs imposed by the efficacy trial burden, Dendreon ultimately filed for chapter 11 bankruptcy.

In addition to the direct costs to companies, the extreme costs and financial risks imposed by efficacy trials have a huge chilling effect on investment in new drugs. If you're an investment adviser trying to avoid losing your client's retirement savings, you're much better off investing in a more stable company like a bomb manufacturer building products to intentionally kill people than a drug developer trying to save lives. So it's impossible to know all the treatments that never even got to an efficacy trial stage due to the effects of decreased investment due to the regulatory risks.