Friday, September 5, 2014

Screw you, FDA

I was visiting a hospital a little while ago chatting with random people and someone who used to work for the FDA was there and talking with me about why he left. I won't go into why he left other than politics, not getting valuable experience, judging medical devices while he actually didn't have any experience in designing them, etc.  He's in the med device industry and we were whining about his former employer. Fun times. 

Then something came up today. A device that I've taken to two countries with tremendous success on terminal patients got outright rejected here in the US for really stupid reasons. The kind of reasons that seem to be a combination of politics and dumb reviewers. I know some of those at the FDA have experience in medical device design, but 90% of the comments are either: you need to prove this totally inert material is safe, or you need to do tons more animal studies. I can see how small companies have no damn chance to get their devices out to save lives since my GLP animals are $8k each. 

This device has already been proven safe in people in other countries and the beaurocracy really pisses me off. I would far prefer my tax dollars were spent on education and training people in universities in how real medical devices are actually designed, a better understanding of the diseases so disease-targetted devices are better judged, and better biomaterial sciences...actually just all better education. When patients are traveling to Euro to get a treatment because the FDA can't get their crap together, it breaks my heart.  The government is not helping its citizens here. The FDA is hurting them.  

I have a treatment that has been working for a while in Euro. It's my first treatment that has cured 100% with 0% complication (after 6 months....).  If my family has this disease, with the next best option a highly invasive surgery with ~60% efficacy (6 month follow-up), I would have to fly them overseas and pay doctors in another country to get better success.  I've heard stories of companies faltering because of the beaurocratic mess that is the FDA. Companies with great treatments. And then there's the cost partly because of the FDA. I've been given the opportunity to target low-incidence disease in my work because of how much capital my company has, but most companies will not because the cost to get a device or drug to market is so high that you have to target high-incidence to get your investment back. I don't know a way to fix this, but I'm certain there's got to be a way. 

I wish I could say that at least I won't have to deal with this when in at my new school, but my intent is to still create devices and get them to patients. I just won't have the backing of a huge company now so it will be very very difficult. Thanks FDA. Screw you. 

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