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"Some of the wisest auditors say that there are only three internal control objectives: to gain assurance for reliability of financial reporting, compliance with laws and regulations, and efficiency and effectiveness of operations. That's it. What you and John are talking about are just different slides of what is called the 'coso Cube.'"

designed to make it extraordinarily easy to get a drug approved. All you have to do is produce two trials--any time, anywhere in the world--that suggest some positive effect of the drug. If there are two, and there is some effect, that's enough. So you could have a situation in which there are one thousand scientific trials, and 998 find the drug doesn't work at all, and two find there is a tiny effect--and that means the drug will be making its way to your local pharmacy.

Third, even though the drug cartels are models of nimble, borderless global commerce, efforts to regulate them are still clumsily national in scope. The result is that the industry survives by slipping from one jurisdiction to another, easily outwitting the uncoordinated efforts of different countries.

Health care was the most highly regulated industry in the country and for good reason: the lives of patients were at stake.

In nearly every case, the powerful argument that these disruptors have used is that the regulations that governed their particular sector were created many years earlier for an entirely different era. They had since become overbearing, unnecessary and damaging to the best interests of customers.