It appears that the completely archaic notion of mass-produced drugs for the average patient is about to change (1). The manufacturers paid lip service to personalized medicine for nearly a century and it was clear that their heart or business models were never in it. The normal function may have done as much damage to humanity as nuclear weapons, for those who adhere to it blindly believe in averages and standard deviations based on a manufactured construct. The only redeeming quality of humans is that they are different and diverse. As the men in power separate the weak from the wealthy, the struggling from those who never struggled, the golfers from those who cannot afford a club, the academics from practitioners, the atheists from the religious, the North from the South, the West from the East, they miss an important point - every human on Earth is different, regardless of the visible features they exhibit or where they originate from.
The design of clinical trials seems to fail this basic notion. Pushing humans through protocols like cattle through a food manufacturing company is not the best way to discover drugs. It is certainly the best way to reduce costs and to prove to the regulators that something important has been done. In the process, they left large underserved populations in the lurch and pumped those who take the medicine with a dose that is suboptimal. Emerging technologies are immensely capable to figure out who will benefit from a drug and who will not and at what quantity. It is time statisticians left the industry as their contributions do more harm than good, not unlike the insurance industry, clinging to actuarial tables.
Now, available technology can titrate every individual to the optimal dose and we do not need, "population statistics," to approve or to disapprove drugs. If the regulators do not return to school to learn what has been happening, they will continue to make bad decisions.
(1) Digitization of multistep organic synthesis in reactionware for on-demand pharmaceuticals
Philip J. Kitson, Guillaume Marie, Jean-Patrick Francoia, Sergey S. Zalesskiy, Ralph C. Sigerson, Jennifer S. Mathieson, Leroy Cronin*