Yesterday, the Food and Drug Administration named Dr. Vinay Prasad, a San Francisco oncologist, as its top regulator for vaccines and other complex drugs called biologics.
This is a YUGE move.
I know Prasad. He is deeply thoughtful about the value and cost of new medicines. He understands the games Big Pharma plays to win approvals for expensive new drugs that all-too-often have little benefit — and hidden risks.
Those games often rely around the design of clinical trials: keeping them short for a drug that may be used for years; including only the healthiest possible patients (for example, the Covid-19 mRNA vaccine trials included few people over 80, who should have been the focus of the trials); comparing them to other drugs that have serious side effects and are not the true “standard-of-care.”
They also include pressure campaigns to push regulators to quickly approve drugs for serious conditions like cancer on the basis of “surrogate endpoints.” Drug companies, and the desperate patients they work with and fund, argue any treatment is better than no treatment.
They’re wrong.
Even for people who are dying, they’re wrong — at least on the institutional level.
The human body is incredibly complex. Efforts to modify disease and healing processes are even more complex. Medicine is rife with stories of treatments, from bloodletting to lobotomies, that did more than harm than good but that became accepted cures for decades or centuries.
Hellbound and Down 