Alex Tabarrok, writing at Medical Progress Today
Initially, it was hoped that understanding the genetic code would lead to a slew of blockbusters as we found genes that we could simply switch on or off. Instead of finding master switches, however, genome-wide association studies have tended to find lots of small contributors to disease, with different people having different contributors. As more people are sequenced, it is likely that we will discover even greater heterogeneity of both diseases and persons.
Instead, we must move the FDA away from pre-market gatekeeping and towards post-market surveillance and information provision. By lowering the costs of FDA approval we can increase the profitability of researching and developing drugs for small patient populations. Less pre-market gatekeeping should be combined with universal electronic medical records and extensive post-market surveillance. In an optimal system that trades off risk and benefits, and the better post-market surveillance becomes, the more we should reduce pre-market gatekeeping.
This the type of smart near term based regulatory action I am talking about. We don’t have to be right about the future. Personalized medicine might turn out to be crap in the long run, and indeed I would bet the rejuvenation is going to be a generalized blockbuster treatment that makes most of this stuff unimportant.
Nonetheless, we can see the FDA pinching the market for drugs today. We can see the high costs of R&D today. And, we should do something about it today.
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Thursday ~ October 6th, 2011 at 11:44 am
bdbd
“Trust but verify,” as they say?
Thursday ~ October 6th, 2011 at 12:33 pm
Corey Mutter
On “The Incidental Economist” blog they have a series of posts teasing out where the USA overpays for health care (that is, how much more we spend than other industrialized nations, even after accounting for our higher GDP per capita).
It turns out the amount we’re overpaying for drugs is larger than the pharmaceutical industry’s entire R&D and marketing expenses combined.
So, though every little bit helps, there’s probably lower-hanging fruit than reducing the contribution of red tape to R&D costs.
Thursday ~ October 6th, 2011 at 12:37 pm
Anon
The reason for high R&D are not drug safety regulations (not sure about you but I prefer to take well-tested chemical substances which are so potent that most of them, if taken in a slightly higher dose, are poisons).
A leading reason for high costs are patents:
1) consider the about one dozen private medical research centers that are in existence and do research today. How do they operate? Mostly in absolute secrecy: research staff operates under strict NDA’s and they are not allowed to talk to researchers of competing firms most of the time. The reason? To get the next key patent granted exclusively it is absolutely paramount to file first.
So these firms don’t share resources, computer clusters, intermediate results, theories, nothing. They are a dozen mostly walled off castles of closely guarded secrets – often working on the same topic in parallel.
It’s epic waste and epic inefficiency as far as humanity goes. (The firms do fine financially, because via patents they are able to recoup costs and profits by taxing the rest of us via overpriced medicaments.)
2) Non-practicing entities (patent trolls) impose an extra cost as well – without innovating. (This cost too is recouped via customers)
Friday ~ October 7th, 2011 at 9:28 am
Barry
Adding on to Anon’s comment – the point is not to do any more research than is necessary to ‘stake out a claim’. Once that’s done, they undoubtedly refocus their research. This is rather destructive rent-seeking.
Friday ~ October 7th, 2011 at 9:59 am
Tel
I always rocks me how many people claim to believe in millions of years of human evolution, and also believe that in an afternoon they could knock up a significantly improved model.
Think about it guys.