Friday, December 2, 2011

Frezza: Science in Thrall to the FDA

In the November-December 2011 issue of Bio-IT World magazine, Bill Frezza of the Competitive Enterprise Institute describes, "Science in Thrall to the FDA".

He describes how FDA regulations hamper medical innovation at a time we need it most. From his article:
A report recently released by the Milken Institute -- "The Global Biomedical Industry: Preserving US Leadership" -- documents how the wheels of progress have been slowly grinding to a halt as the FDA raises the bar for drug approval. The length of time required to complete clinical trials over the past decade is up 70%. The median number of procedures required per trial is up 50%, as is the total work burden per protocol. Meanwhile, volunteer enrollment and retention has been driven down by 21% and 30% respectively. And, of course, new drug approvals are down 50%. Keep this up and it won't be long before clinical trials follow U.S. manufacturing to China, with other elements of the pharmaceutical industry trailing closely behind.

Even as trials drag on with preliminary information kept blinded, new laboratory developments that could improve results are banned due to an insistence on maintaining rigid conformity to outdated protocols. In what other industry does this happen? The calls for "adaptive trials" that might be more suitable in an age of personalized medicine remain unheeded. And the shameful spectacle of denying Americans access to drugs that are approved and available in Europe and elsewhere defies justification.
Frezza also offers steps to move us in the direction of greater freedom:
But there are modest steps we can take in the meantime. How about carving out one or more FDA-free Enterprise Zones where doctors, scientists, and volunteer patients can make their own decisions unfettered by the heavy hand of regulators? Imagine an experimental terminal-illness wing of the Cleveland Clinic where informed consent was the only law. How hard would it be to draft enabling legislation?

Defenders of the FDA's prerogatives would fight such proposals tooth and nail. But what kind of nanny state arguments can be made against conducting such a policy experiment when anyone who objects doesn’t have to be treated? Breakthroughs that emerge would still have to pass through the FDA gantlet before they would be generally available. The difference is that researchers could continue making improvements while treating volunteers during this long process.

If we fail to arrest the regulatory assault on medical progress in the U.S., sooner or later out-of-the-box solutions like the one described above will pop up—elsewhere. And American patients will follow. The price of a plane ticket is trivial compared to the cost and consequences of cancer.
Sick patients will naturally seek the freedom to pursue their best medical interests. A proper government will respect that desire by reducing the regulatory obstacles, not reinforcing them.

(Read the full text of "Science in Thrall to the FDA".)