Good points. Just allow me a moment to air one of my complaints about the debate over off-label prescribing. In this debate, the word "approved" generally is used as shorthand for "approved by the US Food and Drug Administration for a particular purpose." When someone says "the drug is not approved for that use," what they mean is "the US FDA has not explicitly approved that drug for that use."

The implication is that, somehow, the US FDA is the final authority on the matter. They are not. Additionally, the implication is that the lack of such approval means something. All it means is that the manufacturer of the product has not spent the time and money to prove to the satisfaction of the FDA that the product is safe and effective for the purpose in question.

Once a drug has gone generic, it no longer makes sense for a company to make that investment. Therefore, if a new use is found for an old drug, it is unlikely that anyone is going to spend the money to get approval. The lack of that approval cannot be taken to imply that the drug in not safe or effective for the new purpose.

No one gave the US FDA the authority to have the last word on the appropriateness of a particular drug for a particular patient. In fact, it was a well-considered policy decision for the FDA not to have that authority. The authority resides in the collaborative effort of physician and patient.

I agree that flexibility in pharma development and application is desireable, but aren't you minimizing the possibility for both abuse and mis-application by incompetence?

The labelling and communication of efficacy and side-effect profile is a complicated business, possibly too complicated to be left to government regulation, but it certainly isn't a simple problem. And increasing the amount of 'nonstandard' uses and/or new uses and new drugs means that the problem becomes more complicated.

Certainly there is the potential for great assymetrical gains, but how can we ensure they remain greater than the losses? Saying that it's an information technology problem doesn't mean that it's trivial or possible.

Do you have a pet theory for some public database of drug use, profile, and collabrative reporting?

I am seeing significant strides in the area of what is called "mass customization", which is moving from online ordering of custom tailored clothing to nutriceuticals, customized in powder form to your personal mix, based on your lifestyle and/or an analysis of your DNA. Prices for DNA/lifestyle profiling are running a few hundred dollars now.

What I forsee next is neurochemical profiling via either DNA, MRI, lifestyle, spinal tap, or a combination of these, which will result in a neurological profile to provide custom mixed cognitive enhancement drugs, available as pill, powder, patch, or inhaler.