There have been several hearings in Washington on the drug industry and drug prices, and there are going to be more. Drug pricing is a large and messy issue, for sure, and all I’ll say about it today is to ask everyone to read Jack Scannell on it before expressing an opinion. I’m not going into pricing in this post at all – I have another issue. One exchange in particular from the House hearing is going around (several people have sent me the clip already), and I wanted to address it because it’s not so much about drug pricing as where drugs come from. And that is a subject I can speak to, and one where there fact/opinion ratio is perhaps a bit more favorable.
AOC: “Would it be correct, Dr. Kesselheim, to characterize the NIH money that is being used in development and research as an early investment? So the public is acting as an early investor in the production of these drugs. Is the public receiving any sort of direct return on that investment from the highly profitable drugs that are developed from that research?”
AK: “No, in most cases there is – when those products are eventually handed off to a for-profit company, there aren’t licensing deals that bring money back into the coffers of the NIH. That usually doesn’t happen.”
AOC: “So the public is acting as an early investor, putting tons of money in the development of drugs that then become privatized, and then they receive no return on the investment that they have made.”
So we’re going to do this again. I have written numerous times here about the NIH’s role in drug discovery (and that of academic science in general). And I have written many times about the persistent idea that pretty much all drugs are discovered either at the NIH or with NIH funds, whereupon Big Pharma comes in, scoops them up for beads and trinkets, comes up with a catchy name and goes off to reap the big tall stacks of cash. I would say that the exchange above reflects this view, albeit with a bit less vivid detail.
It’s wrong. I know that this picture of the drug-discovery process is just irresistible catnip to some people, but it’s wrong. Here’s why, and here‘s why, and here’s why, and here’s why, and here‘s why again. I’m not saying that there are no drugs that have been born in academic labs, of course – there certainly have been (for a look at one, try Lyrica/pregabalin). But as one of those links details (in an analysis of the 1998-2007 period), such drugs are definitely a minority. This fall I will (I hope) celebrate my 30th year of doing drug discovery research, and never once have I worked on a project where the chemical matter came from an academic lab. You can, in fact, buy entire books that teach academic labs what drug development is really like.
Identifying an interesting protein or cellular pathway, which is what academia does very well, is not inventing a drug. And even on those occasions when an academic lab has identified new chemical matter, a hit in your screening assay is not a drug, either. I’ve gone into detail about the steps in between, but let me just say that I have spent my whole career, one way or another, on just those steps. So when I hear people acting as if none of that exists, that the process is NIH-to-marketed-drug, then I get a bit worked up.
Another point: you would get the impression from that clip above that the NIH hardly ever realizes any revenue from licensing its own discoveries. But that’s wrong, too. The agency has not been very forthcoming about the terms of those licenses and how they’re awarded (as that link shows), but one of their own administrators has pointed out, and he’s absolutely right, that “Because many, if not most of the technologies developed at the NIH and FDA, are early stage biomedical technologies, the time and development risks to develop a commercial product are high“. Early stage biomedical technologies are like that. Note that he does not seem to know about a lot of market-ready drugs. And concentrating on the highly profitable successes, as mentioned in the exchange w/Dr. Kesselheim, glosses over who gets to participate in the far more numerous failures, some of which are rather expensive themselves.
Rep. Ocasio-Cortez: it is absolutely your job to participate in hearings like the above, to question those appearing at them, and to look into such issues. But it’s also your job to know as much about these issues as you can. Right now, your knowledge of where drugs come from appears to be seriously inadequate. To be fair, you’re definitely not alone in that, but there’s no reason not to learn more. Unless you, like many of your colleagues on both sides of the aisle, are mostly interested in generating zippy sound bites and looking dynamic for the next round of fund-raising and the next election. In which case, carry on. But that would be sad.