In May 2015, the 21st Century Cures Act was introduced in the US House of Representatives. It has a lovely ring doesn’t it? I mean who could be against Cures, and indeed the House Committee approved it unanimously. Its goal is to promote the development and speeding the approval of new drugs and medical devices.
This bill is championed by the pharmaceutical, biotechnology, and device industries (collectively Big Pharma) who want to encourage the use of “shorter or smaller clinical trials” to accelerate approval of their new products. The underlying premise of the bill is that the current process is too slow and inefficient, but that is simply not true.
The fact is, more than two thirds of new drugs are approved on the basis of studies lasting six months or less. A third of new drugs are currently approved on the basis of a single pivotal trial, the median size of which is just 760 patients (flimsy scientific evidence), and there is no proof that they work any better than the ones they are replacing. We also don’t know anything about their long-term side effects because they haven’t been around long enough.
What we can predict with absolute certainty is a slick marketing campaign promoting these new, improved, updated (but basically similar) versions of their products, and that they will cost more than the current inventory.
We do not need shorter or smaller clinical trials; we need bigger and longer ones. The 21st Century Cures Act is not about curing at all; it’s a sales promotion strategy. Let us instead fund the NIH (whose budget has been stagnant for years) and give them enough to fund independent research (not Big Pharma sponsored research), and create more efficient ways to disseminate those results. Don’t pass this bill.