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.
Carl,
Have you passed on these comments to your AZ legislators? Any response? (I agree.)
The Government is great with misleading titles aren’t they? If they are talking about real cures, how about alternative health solutions that are evident right now but silenced by Big Pharma and laws they enact? They are not interested in cures, as cures exist but not the ones that make them big bucks.
Hi Carl,
Love your idea to give funding to those with intention to contribute something new. Trouble is that so many have become so used to politically correct euphemisms that few remain who hear the spiels and don’t mistake it for something real.
I don’t believe that any prescription drugs should be advertised to the public. That was what started this whole mess of out of control Big Pharma. Stop that and the problem will be mostly solved, albeit with much smaller drug companies. Find the cure, rather than managing the symptoms — and I agree many of the cures are right under our noses!