- Patients should have the ultimate say regarding what treatments -- and risks -- they take.
- The studies neglected a subgroup of women whose tumors respond well.
- Today's science lags behind today's patients' needs, so proceeding without the science is acceptable.
- We need to prevent government from overstepping bounds and abusing regulatory power.
- Without FDA approval, some insurance companies won't pay for it.
- Decisions must be driven by scientific proof, not emotions or public pressure.
- Making such drugs available off-label will deter patients from enrolling in clinical trials.
- Controlling healthcare costs depends on funding only proven therapies.
- Revocation strengthens the accelerated approval process by respecting the results of subsequent studies
From my perspective, the problems stem from having a one-size-fits-all trial system bogged down in bureaucratic layers and conflicts of interest.
With today’s technology and resources, it is not wishful thinking to believe we could develop more efficient methods of moving promising treatments through the research and approval pipelines. I'd like to see Americans work to develop a healthcare system in which...
- Most patients are treated in trials.
- A variety of trial structures exists to match patients' circumstances (e.g., treatments for life-threatening diseases with no other treatment options, treatments of minor health problems, side effects, and so on).
- We optimize the use of computers to collect and analyze available data.
- The physician-patient bond is preserved.