Editor's focus: Struggling toward a prize we may never gain
Life sciences and pharma know-how have achieved a lot, but expecting drug discovery and development to be like construction and manufacturing is asking a bit much
There is a passage by the apostle Paul in one of the books of the Christian Bible that often sticks in my head, both theologically and as a general life lesson, and in one of the Bible translations it goes like this: “Not that I have already obtained, or am already made perfect: but I press on, if so be that I may lay hold on that for which also I was laid hold on by Christ Jesus.”
The gist is basically, “I’m not perfect, but I keep trying to get closer to the goal of being so.” Not spoken directly, but heavily implied, is the notion of “...and I’m never going to get to that goal either, buddy.”
As I said, it’s a good rule of thumb in life beyond the spiritual realm and regardless of whether you believe in any kind of higher power other than the ones that collect taxes from you.
This passage was brought to mind after one of our regular columnists at DDNews, Peter Kissinger, sent me a link to an article at www.raps.org titled, “FDA’s Woodcock Weighs in on Role of NIH in Drug Development.”
Look, I was mostly on board with a lot of what Woodcock had to say, as related in that article, especially the part about how academia and the National Institutes of Health are great for early research but should not be looked to for the actual development of pharmaceuticals.
She lost me a little when she complained about how the pharmaceutical industry doesn’t share information. It’s not that this lack of sharing doesn’t bother me; it does, because it’s one of the biggest stumbling blocks toward moving therapeutics forward faster. But also, in a capitalist society with things like patents and intellectual property and fierce competition, it’s kind of hard to see how much of a dent can be put in that problem.
But where Woodcock really lost me, and reminded me that neither being a government official nor having a postdoctoral degree (Woodcock is a physician) means you always have a clue about the industries, areas and markets you deal with and oversee (and by the way, the NIH isn’t part of the FDA, so she was already straying outside her lane), was when she suggested that the drug development process needs to be re-engineered to be more like the airline and construction industries.
As she was quoted: “Usually they can build an airplane and it can fly the first time,” adding that it’s the same for bridges and skyscrapers being functional and reliable for the most part right after they are designed and built, finishing with, “We have to engineer this so it’s not trial and error every time.”
Engineering is not an easy task. There is a lot of science and math in there. But things like wind shear and tensile strength and load-bearing weight and all that is mostly pretty straightforward physics, chemistry and material/physical science.
For goodness’ sake, we only just recently have started to understand just how much the microbiome influences our health and the way medicines affect each of us differently—we are ages away from being able to figure out all the ways this is true. The bacteria alone in our body outnumbers our human cells by a factor of 10.
Also, we still don’t really understand a whole lot about how the brain works, and getting drugs past the blood-brain barrier is still a major issue. We have mapped the human genome, but the myriad ways genes and related materials like proteins interact is going to be a puzzle we will be unlocking for generations to come. And so on.
Let’s just say I don’t wish for things like world peace because I know how unobtainable they are; so too, I do not ask the pharma and biotech world to figure out how to make drugs work right out of the design stage.
Perhaps Woodcock is just being hyperbolic for effect to push us to dream and reach harder toward that goal that none of us are likely to see reached (nor our great-grandchildren, probably), and maybe she qualified her statement elsewhere. But regardless, let’s be as honest as Paul was about our human limitations.