The other evening at a dinner party I sat next to a charming and enthusiastic employee of the FDA. She waxed lyrical about its dedication, expertise and good management.
A few days later, on January 6th there appeared a scathing article about the FDA. It did not criticize the drug authorization program, but it did point out the apparent carelessness with which the FDA treats medical devices – implants, artificial hips, surgical mesh etc. Some 32 million Americans walk around with medical devices in their bodies, some of them very hard to get out if they go wrong. Just one device, a neck implant, is associated with 1.7 million injuries and more than 80,000 deaths – and the public know nothing about it. The FDA insist that high risk devices undergo “stringent“ testing. In fact, only 5% of implantable cardiac devices, for instance, are thoroughly tested and subjected to clinical trials.
The reason given for the laisser faire attitude is that when the FDA was given the job of overseeing medical devices in 1976 they accepted the existing products on the market as being established and safe. In other words they grandfathered them. So now the makers tell the FDA that some new product is old, really, but improved with minor tweaks. In the jargon of the trade it has “substantial equivalence”. This is enough to get it waved through the system, o.k for some products, but not so much for high risk items. The second loophole is called the “supplement pathway”, and applies to new models of high risk devices, such as artificial hips. Either way, potentially lethal devices are in daily use, and the FDA blithely continues its existing policies.
One of the problems is that, like the Agriculture and Aviation departments, the FDA regards the device manufacturers (corporations) as “customers”, not the users (patients). 35% of its regulation cost is paid for by the very companies who make the devices. Since the companies are customers the FDA acts accordingly, hurrying approvals and behaving like any commercial supplier. Moreover, for years the people running the FDA have been recruited from the device manufacturers, or lobbyists for device manufactures.
It is clear that the FDA should be fully publicly funded (only) and be made to rigorously check every medical device, making its findings public. Secondly, the head of the FDA should be a career civil servant, and should not be recruited from the trade. The same thing should be done with the FAA, whose preoccupation is with the success and welfare of the airlines – (and to hell with the passengers), and the Department of Agriculture, whose concern is with the food producers, not the consumers. How all this went wrong in the first place I don’t know, but the politicised situation lends itself to charges of corruption. Faith in transparent institutions, government or otherwise, is an Epicurean principle and is the bedrock of democracy (if we had it!).