Changing small molecule exclusivity rules as a long-term drug price policy play

This piece originally appeared in the Timmerman Report

We’re entering uncharted waters in the US government. I don’t think it’s hyperbolic to say there will be new regulations, new laws that we’ve never seen before. While I don’t pretend to understand the new administration in any way, I do expect there will be more chaos at the level of policy-making than we’ve seen in decades and one thing that chaos does is it increases the likelihood of extreme outcomes.

So here is one speculative policy idea:

I think we should trade the 12-year exclusivity period from biologics to small molecule drugs. Continue reading

No, CRISPR-Cas won’t save the day for ag biotech

You want to know how to drive a scientist crazy? Insist that you believe something that’s not supported by current scientific evidence. Tell her vaccines cause autism, or creationism is just as valid a theory as evolution, or that climate change isn’t really happening, I mean, after all, a monster blizzard hit Washington DC this January! Global warming, pssh…

There’s an old episode of Friends that did a good job of showing how this kind of conversation goes. Phoebe professes not to believe in evolution and Ross, a paleontologist, keeps trying to convince her that evolution is real using scientific evidence and logic. He grows increasingly frustrated and insistent as she continues to deny the basis of his life’s work, finally losing it when she goads him into admitting (like a good scientist) that even theories like evolution are not immune from questioning and testing.

We train scientists to carefully generate, weigh and use evidence. To no one’s surprise, this leads many scientists to generalize and think that in all matters having to do with the physical world we all should and of course will follow the evidence. Yes, sometimes that leads to unpopular ideas, and sometimes the ideas change as the weight of evidence changes. This training can make scientists kind of boring at cocktail parties. Still, the overall scientific process keeps moving forward and it’s because of this reliance on evidence.

But many people (including, at times, even some scientists) don’t always think the same way about things in the physical world. And that’s why I’m pessimistic that CRISPR-Cas technology will peacefully resolve the Genetically Modified Organism (GMO) debate. Continue reading

When a grand old scientist talks, you listen: Maynard Olson and Genomic Medicine

All opinions are my own and do not necessarily reflect those of Novo Nordisk.

Last night I had the great opportunity to hear Maynard Olson give a public lecture on Genomic Medicine.  As one of the founders of the Human Genome Project, he’s been around in a pivotal role for much of the revolution in our understanding of the genome.  A revolution, as he himself points out, that we are still just beginning.

He gave his speech as part of the UW Genome Sciences Department’s summer lecture series, and spoke to a packed auditorium about how the information we are learning about the genome has implications for diagnostics, therapeutics, and public policy.  I’ve heard Maynard speak before, and he’s always refreshingly down-to-earth, candid and measured in his descriptions and comments.  Not for him are flights of speculation or hyperbole, and he actually ended his talk with a call to stop the hype.  As he said, “The product is solid.  It doesn’t need hype.”  Maynard, who is slim, with a fringe of red hair that’s silvering at the sides (kind of like Reed Richards), does not look at all near his age of about seventy years. Continue reading