Thursday, December 20, 2007

Health Care part 1: Fast track FDA approval

I wonder if I am doomed to have long discussions about health care reform every even-numbered year for the rest of my life. But I think I have one idea that even my friends on the left can agree on.

Let's have fast track FDA approval for treatments proven to work in other countries. Beta-blockers had been saving the lives of Europeans for years before the FDA approved their use over here.

Phage therapy is another treatment available outside of the US. The process involves the use of bacteriophage, viruses that infect bacteria, to attack a bacterial infection. Since bacteriophage exist in nature, it's 100% organic if you're into that sort of thing. Unlike other "organic" treatments, this really does work.

Phage therapy has been available in Eastern Europe for decades, but it is still not available here. The reason why? Because it costs a lot of money to clear the FDA approval process. A company would cheerfully fund the required trials if it thought that there would be a return on the investment. Except one cannot patent a process that has already been invented elsewhere, so there is no money to be made from this. So if you are inflicted with an antibiotic resistant strain of a disease, you'll likely have to travel to the Republic of Georgia for phage therapy.

I proposed that if a treatment has been proven to work in other countries, the FDA should simply approve it. There is no biological difference between Americans and foreigners, so whatever drug works on them should work on us as well.


LP Mike Sylvester said...

I think this is a no brainer...

I would like to see the USDA and the EU coopoerate, this could cut costs...

Mike Sylvester

Robert Enders said...

The USDA shouldn't do everything that the EU does. For example, a lot of Europeans want genetically modified foods banned. BUt when something is proven safe and effective abroad, the FDA should allow it here.

Phil Marx said...

How about the FDA simply acknowledges that the EU produces valid science. Unless there is a specific reason to question a particular finding of theirs, we should start with the assumtion that it is valid. This would save a lot of time and money on duplicate testing.

Beyond the science, there might be ethical, or social reasons why we don't want to do the same things they do, but that is another matter.

Grace Filby said...

It is hot news that there are 5 phage products available, approved by the US govt, for some food products based on evidence and professional consensus about safety and value to public health. Latest scientific data published by the Polish team points out that phage therapy offers an alternative treatment for Staphylococcus aureus infections at 10% of the cost of antibiotic therapy. In the USA (Lubbock, TX) there is an FDA-approved Phase 1 clinical trial study with patients who have wound infections. See for more info in a Churchill Fellow's Report (Oct.07)

Robert Enders said...

Phase 1 trials means that the FDA is still 10 years away from allowing this to be used on a regular basis. Phage might be able to cure any bacterial infection, even those that resist antibiotics. And they want to sit on this for the next ten years!

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