The U.S. Supreme Court has, without comment, opted not to accept an appeal of Abigail Alliance v. von Eschenbach. This means the federal appeals court ruling that patients do not have a constitutional right to experimental drugs stands.
This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.
That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.
The question is, how to do so with greater alacrity and responsible, robust oversight.
When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.
That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.
We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.
And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance.
This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.
That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.
The question is, how to do so with greater alacrity and responsible, robust oversight.
When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.
That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.
We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.
And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance.
