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Friedhoff lays out the pipeline: identifying a biological target, screening compounds, preclinical testing, then Phase I safety, Phase II dosing, and Phase III efficacy trials before FDA review. Each gate exists to answer a specific question and most candidates die at one of them.
The book explains that the vast majority of candidates fail for lack of efficacy or unacceptable toxicity discovered only in humans. This attrition, not greed alone, drives the enormous cost and time of bringing a drug to market.
Friedhoff, who led development of a major Alzheimer's drug, stresses that approval hinges on rigorous, prespecified trials that statistically prove benefit over placebo. The science of proving a drug works is as demanding as the chemistry of making it.