Get the government on the backs of the medical device manufacturers!

Props to the Archives of Internal Medicine for making this report of general public interest open access. Diana Zuckerman and friends examined recalls of medical devices from 2005 through 2009 -- you know, faulty defibrillators, flimsy hip joints, that sort of thing.

This is a slightly complicated story. As usual, I will attempt to de-obfuscate it if I can. When Congress gave the FDA responsibility for regulating medical devices in 1976, they allowed an exemption from the pre-marketing approval process for existing devices, and ones that were basically similar to them. Instead of doing studies to show they were safe and effective, and having them inspected to make sure they were well made, the companies just had to let the FDA know about them, basically. But, this was only supposed to apply to devices that didn't pose much risk -- tongue depressors, surgical gloves, that sort of thing.

In 2002, in the name of getting government off the backs of the people, the soon-to-be Emperor of Mesopotamia signed legislation that ordered the FDA to use the "least burdensome" regulatory approach for all medical devices. The law still required that risky devices required clinical trials, but the FDA didn't have a sufficient budget to actually carry out that law, so the vast majority of new devices since then have been approved using the so-called 505(k) process, which does not require any clinical trials.

That's right, they didn't have to test them. At all. Of high risk devices that were recalled because they were faulty or dangerous, 80% had been approved using the 501(k) process. And yes indeed, many people have died as a result. Hundreds of people are known to have died due to faulty defibrillators. Others were blinded, or needed corneal transplants, due to faulty contact lens solution.

The FDA needs to have its budget increased so it can enforce laws that are there to protect us. You already know what the Republicans want to do to the FDA budget.

So tell me this. Why does anybody vote for these lunatics?