Wednesday, October 15, 2014

I Want a Investigational New Drug

Do you like Huey Lewis & The News? Their early work was a little too 'new-wave' for my taste, but when Sports came out in '83, I think they really came into their own - both commercially and artistically. The whole album has a clear, crisp sound, and a new sheen of consummate professionalism that really gives the songs a big boost. He's been compared to Elvis Costello, but I think Huey has a far more bitter, cynical sense of humour. In '87, Huey released this, Fore, their most accomplished album. I think their undisputed masterpiece is 'Hip To Be Square', a song so catchy most people probably don't listen to the lyrics - but they should! Because it's not just about the pleasures of conformity, and the importance of trends, it's also a personal statement about the band itself! Hey Paul!
The Food and Drug Administration has protocols for the limited use of not-yet-approved pharmaceuticals. It's called an Investigational New Drug (IND) application, and the most recent changes listed on the FDA website are from 2009. I've heard some rumbling (CNN) that the Ebola incidents in the US could be just the incentive the FDA needs to liberalize its approach to IND protocols, making it easier for patients to gain rapid access to life-saving medication ahead of the approval process.

You can see in the errata how this is of interest to folks concerned about justice in exchange here, a DHHS document demanding doctors provide a written explanation of their justification for charging patients for the use of IND. Patients with severe or fatal illnesses face desperate alternatives, so it would be unjust to take from them great sums of money in exchange for a promise of extra life. Put another way, patients whose life is threatened cannot reliably negotiate fair terms of trade, as the costs of failing to exchange are unacceptably high. INDs by their very nature are easily prone to exploitation.

Then again, the failure to develop and release drugs promptly obliges the terminally ill to either accept legacy treatments or just die. The media hysteria surrounding Ebola, for all its balderdash, might well help shine a light on the life-threatening hurdles the FDA places in the way of drug development.

The efficacy rule intends to make all pharmaceutical exchanges euvoluntary at the cost of fatal delays. It's past time to retire this rule and start saving lives.

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Do you have suggestions on where we could find more examples of this phenomenon?