Why all pharmaceutical research should be made open access
'The decades-old industry practice of suppressing scientific evidence leads Bad Pharma author Ben Goldacre to declare that nothing we know about modern medicine should be assumed to be correct.' Photograph: Doug Steley C/Alamy
I recently had lunch with as staunch an advocate for open access as you'll ever meet (I won't name him, because it would be rude to attribute casual remarks to him without permission). We were talking about plans to mandate free and open publication of publicly funded scientific research. In the USA, there's the Federal Public Research Act, and in the UK, there's the coalition government's announcement that publicly funded research should be made available at no cost, under a Creative Commons licence that permits unlimited copying.
We'd been talking about Ben Goldacre's excellent new book, Bad Pharma, in which Goldacre documents the problem of "missing data" in pharmaceutical research (he says about half of the clinical trials undertaken by the pharmaceutical industry are never published). The unpublished trials are, of course, the trials that show the pharma companies' new products in unflattering lights – trials that suggest that their drugs don't work very well, or don't work at all, or are actively harmful.
The decades-old industry practice of suppressing scientific evidence (and some independent researchers doing the same) leads Goldacre to declare that nothing we know about modern medicine should be assumed to be correct, and he makes the urgent case for forcing the release of all that pharma dark matter so scientists can re-run the numbers and work out what actually does work.
I mentioned this to my lunchmate, finishing with: "And that's why all pharma research must be open access."
"All publicly funded pharma research," he said, as though correcting a mistake in elementary arithmetic. "If the public pays for it, they should see it, but if pharmaceutical companies want to pay for their own research, well …"
I knew where he was coming from. One of the strongest arguments for public access in scholarly and scientific publication is the "public debt" argument: if the public pays you to do research, the research should belong to the public. That's a good argument, but it's not the whole story. For one thing, it's vulnerable to the "public-private partnership" counterargument, which goes, "Ah, yes, but why not ensure that the public gets a maximum dividend on its spending by charging lots of money for access to publicly funded research and returning the profit to the research sector?" I think this argument is rubbish, as do most economists who have studied the question.
The public good of freely accessible, unencumbered research generates more economic value for the public than the quick-hit sugar-rush you get from charging the public on the way in and again on the way out. This has held true in many sectors, though the canonical example is the massive public return from the US Geological Survey's freely usable maps, which have generated a fortune that makes the ransoms collected by the Ordinance Survey on its maps of the UK look like a pittance.
That's why Goldacre's work is important to this discussion. The reason pharma companies should be required to publish their results isn't that they've received a public subsidy for the research. Rather, it is because they are asking for a governmental certification saying that their products are fit for consumption, and they are asking for regulatory space to allow doctors to write prescriptions for those products. We need them to disclose their research – even if doing so undermines their profits – because without that research, we can't know if their products are fit for use.
This is similar to the argument for using free/open source software in industrial and health applications, such as the OpenEyes system developed by Moorfields eye hospital and other institutions around the world, following the collapse of the NHS's electronic health record project. They didn't plump for an open system instead of a proprietary one for ideological reasons, but rather for eminently practical ones. No hospital trust would ever allow a firm of engineers to build a new wing for a hospital using secret proprietary means to calculate their load-stresses. They wouldn't accept a new wing where the as-built drawings were a secret, where the location of the ducts and trunks was known only to the contractor. I
t's certainly true that engineering firms and architects could make more if their methods were proprietary, but we demand openness because we need to be able to maintain hospitals regardless of the fortunes of any engineering firm, and because we need the reassurance you get from being able to double-check the load calculations on your own. The IT systems used to manage the patients in the hospital are every bit as vital as the location of the ethernet wires in the walls, and so Moorfields expects them to be as open as the architectural plans for their buildings.
And that's why big pharma needs to show its work: because regardless of their bottom line, their products mustn't be allowed into the market without such a showing. It's important to get publicly funded work into the public's hands, but that's where the open access story starts, not where it ends.