Could ‘Yelp for Drugs’ Work at FDA?
A lengthy online story for Vox questions whether a Silicon Valley approach that reduces or eliminates FDA’s efficacy requirements for new drugs could work. The article says it appears that the Trump administration is using PayPal founder Peter Thiel to help review candidates for the position of FDA commissioner. It notes that Thiel has repeatedly made the case that the agency interferes with drug innovation by making it too difficult for new drugs to get to the market. He and others who have been named as possible commissioner candidates have suggested it would be better if FDA operated more like a “Yelp for drugs” in which the speedy and disruptive approach Silicon Valley brought to the taxi and hotel industries would be used in the service of discovering new cures.
“Thiel and his pals miss a very important point about developing new drugs,” the article says. “Manipulating biology isn’t the same as manipulating computer code. It’s much, much harder. Speeding up medical innovation will take a lot more than just stripping down FDA. It’ll take huge leaps forward in our understanding of biochemistry and the body. Healthcare is also different from taxis and hotels in another key way—consumers can’t really judge the safety and quality of medical products by themselves.”
Pharmaceutical scientist and political conservative Derek Lowe told Vox that the reason he has tested thousands of compounds but never brought one to market is, “We don’t know how to find drugs that work…. It’s very tempting for someone who has come out of IT to say ‘DNA is code and cells are the hardware, go in and debug it.’ But this is wrong.”
Lowe added that the “clinical failure rate is not 90% because FDA are such bastards. The clinical failure rate is that high because most drugs don’t do what we thought they were going to do.”
Stanford University Center for Law and the Biosciences director Hank Greeley said that “knowing whether drugs are safe and work is something far beyond the common knowledge of patients, and is frankly far beyond the knowledge of most physicians.” He said lessons can be learned from an example of what a much less regulated drug world would look like. “It’s called the nutritional supplement industry. And it’s a travesty.”
The article also says that while FDA’s new expedited pathways have made it the fastest medical regulatory agency in the world, there are no compelling data showing that the newer drugs have clinical advantages over older therapies. “So there’s little evidence that speeding up approval times has helped spur innovation,” it says.