Sunday, November 21, 2004

Drug Regulation

Dr David Graham, described by the FT as a safety official, told US senators last week that the FDA system was broken because of a conflict of interest.

According to the Financial Times, the FDA once enjoyed a high reputation. Few consumers challenged its judgement. The FT writes: "Such trust is one reason why the US public has been more willing than Europeans to accept foodstuffs containing genetically modified organisms."

So what has eroded this authority trust? The FT identifies two factors that may be relevant.
  1. One can detect a regulatory cycle in drug approval. Testing standards became tougher after Thalidomide, were relaxed when AIDS stimulated demand for new and experimental drugs, and so on.
  2. Division of responsibility and inconsistent handling of drugs at different stages of the innovation lifecycle. Approval follows one process; monitoring of approved drugs is done by a different department and follows a different process.
Oscillation and internal contradiction are both natural phenomena of complex systems, and tend to have a destabilizing effect on trust. One obvious response to this is to distrust complexity. But denial of complexity may merely create a false illusion of trust. Authentic trust may just have to accept oscillation and contradiction.

So whither the FDA - towards a restoration of authority, or towards an engagement with authenticity (if we can believe that)? Either way, a more intelligent and honest attitude to risk (as recommended by the FT) will be useful.

Source: FT Editorial No Pain-Free Option (November 20, 2004)