I’ve never known quite what to make of the “open source pharma” idea. I know that there are a lot of people working on things in this area, and that there’s a lot of interest. But as someone who does drug discovery for a living, I can’t quite see how it can work. And I’m not sure if that’s just because I know a lot about the subject (and I’m therefore more realistic about it) or if it’s just because I know a lot about the subject (and I’m therefore stuck in my standard ways of thinking about it). Too much of the talk in this area seems to be confusing it with open-source software, without realizing that any such confusion is possible, and seems to devolve into vague generalities far too easily.
A reader sent along this link, a blog from a legal firm specializing in standards-setting and technology consortia. The author just got back from a conference on the whole open-source-pharma idea, and seems to have absorbed the general tone of the meeting. And that tone is. . .well, I have to say that it’s not completely wrong, but it’s not quite in synch with reality, either. There’s a lot of talk about how most of the innovative work is done in universities, and how there are “hundreds of promising discoveries” that never get properly looked at by Big Pharma, and how there are so many drug repurposing possibilities that no one is even bothering to look at, and so on.
This is too simple a view of the world. For one thing, it seems to posit that there are a bunch of dreamy-but-innovative academic labs, and then there’s Biiiig Phaaarma, who buys up their innovative innovations. Not much in between, apparently – there’s a passing reference to small companies being bought up, but that’s just in the context of all their good ideas being smothered. But a lot of these small companies come right out of university research, and there’s this whole mechanism called “venture capital” to get them going. Some of that VC money, in fact, is coming from the big drug companies themselves these days. It also ignores the long history of companies, academic labs, and even the NIH in trying to repurpose known drugs and abandoned projects. When someone comes along talking as if this is an idea that’s just never been tried before, it makes me suspicious about what else they don’t know.
Then there’s this:
Proprietary practices have other pernicious effects as well. Multiple pharmas may be exploring the same drug possibilities at the same time. Worse, one company may have already learned that the line of inquiry is a dead end, either because the animal trials did not replicate in humans, or because of toxicity. Similarly, where research is not published until the patents have been filed and the drug introduced, a decade or more can pass before other researchers can benefit from and build upon it.
Ah, but if some drug wipes in the clinic, other people know about it. We actually keep pretty close tabs on each other in this business. Companies tend to announce it when an interesting program goes into clinical trials (investors and all, y’know) and the advent of clinicaltrials.gov has formalized that process. And they most certainly do announce it when that clinical trial fails or succeeds (investors and all, y’know), and everyone finds that out long before the paper gets published. You’d also think that a technology-focused law firm would realize that other researchers can even benefit from patent filings as well as journal articles.
And it’s pernicious that “multiple pharmas may be exploring the same drug possibilities at the same time”, is it? Anarchy! That is a feature of drug discovery, folks, not a bug. That’s how things get discovered. You may note – if you take a few minutes to look into it – that most of the time, the majority of these programs don’t actually work, but one or two make it through. Which one or two, though? Can you tell at the beginning which companies will succeed? Not at all. That’s why having several investigating the same area is actually a good thing, for the most part. That phrase “the same drug possibilities” also makes it sound as if these multiple companies are pretty much working on the same compounds, but that’s not what happens, either. People have different chemical series, with different advantages and different liabilities, and that’s most certainly a good feature, too, given the state of our predictive abilities.
Here’s the part where the post really starts talking about what might replace our current system:
But imagine, if you will, if we were to map out the entire drug development process from initial theory through research, clinical trials and regulatory approval (and there are many, many sub-steps along the way). After we’ve produced our detailed work flow model, we can then spec out the type of IT platform needed to support that end to end process, and also the type of database needed to hold and share all the resulting data.Of course the software tools we will want to use will insure that all of the data from one end to the other is in compatible formats to maximize efficiency in developing that drug, and also to permit maximum universal use of the resulting database by other researchers. The software tools comprising the resulting framework will be best of breed open source tools (many of which already exist), and to the extent that there are gaps, existing tools can be optimized, or new ones created.The work flow model will also specify exactly what number of individuals, with what skills, are needed at each step along the way. It will also identify the points at which crowd sourcing of knowledge from appropriate experts would be helpful, as well as what types of funding might be appropriate and available at which junctures. Importantly, it can also be designed in such a way as to dramatically drive down the costs at every stage, from beginning to end.