Richard Smith: Pharmaceutical companies follow public funders of research in efforts to reform science publishing

richard_smith_2014Funders of research are the one group who have the power to change the slow, inefficient, old-fashioned, wasteful, arbitrary, and, some would say, iniquitous way that we publish science. About half of biomedical research is funded by pharmaceutical companies, but they have been much slower than public funders of research to use their influence. Open Pharma, which “works with pharma to drive fast and transparent medical publishing,” is encouraging pharmaceutical companies to use their influence more. The group met last week and discussed promoting open access and finding ways to link together the material on particular issues—perhaps a single clinical trial, a drug, or a disease—that currently is widely scattered and hard to find. (I chaired the meeting: see conflict of interest statement below.)

On the day of the meeting only one pharmaceutical company—Shire had mandated open access for the research it funds, whether undertaken by its employees or outsiders. Indeed, remarkably it seemed to be the only for-profit company to have done so—despite hundreds, probably thousands, of public bodies having mandated open access. (The day after the meeting another pharmaceutical company, Ipsen, also mandated open access.) One ironic reason for pharmaceutical companies being so slow is that they are heavily regulated and uncertain how regulators will view mandatory open access: one, it seems misplaced, worry is that they might be seen as promoting their products directly to patients, which is illegal in most countries. Another reason is that big companies are risk averse and decisions like mandating open access have to be agreed at a high level, and open access is not a priority for those at the top of the companies.

Shire presented the first-year results of its policy and showed that the number of studies published open access had increased from about 80% to about 90%. I was surprised that it was so high before the policy was introduced, but other companies at the meeting confirmed that around 60% of their research studies were published open access. It’s surprising when only about 25% of all studies are open access. Although pharmaceutical companies have been slow to adopt policies that mandate open access, those at the meeting had been encouraging open access publishing for some years. Shire still has 10% of studies that are not open access for various reasons, the main one being that the studies were submitted before the mandatory policy was introduced.

But at the meeting the pharmaceutical companies were challenged to leapfrog over years of slowly ratcheting up their policies, as most public funders have done, and join cOAlition S; the coalition supporting Plan S, which has been developed by the European Union and requires that all research it funds must be immediately and fully open access from the start of 2020. The proposal threatens many traditional journals whose income depends on subscriptions. In particular, the plan will not allow publication in “hybrid journals,” those that continue to charge subscriptions, but also allow authors to publish their studies open access if they pay.

There seem to be three main reasons why pharmaceutical companies are likely to be reluctant to join cOAlition S. Firstly, Plan S is controversial, and, as I’ve said, the companies are risk averse. They also, I believe, suffer from the prevailing narrative that they are “bad guys,” so that anything they do is likely to be seen by some as malign. In contrast, public funders like the National Institute of Health Research and the Wellcome Trust are “good guys” and always assumed to be working in the public interest. Secondly, Plan S threatens the stability of “learned societies” (like, for example, the British Cardiac Society) that depend on income from their publishing. Pharmaceutical companies want to be friendly with these societies, which are run by the all-important KOLs (Key Opinion Leaders).

The third reason for the reluctance of pharmaceutical companies to join cOAlition S is that Plan S requires research to be published with a CC BY license, which is not allowed to pharmaceutical companies by many major journals. Because this licence means that anybody, including commercial organisations, can reuse the research, the journals fear that it will undermine their income from reprints, which are purchased by pharmaceutical companies in large numbers. Reprints bring in millions to some major journals, and crucially they are highly profitable (with about 80% of the income being profit). But it emerged at the meeting that this worry by the journals is probably misplaced: increased open access publishing does not seem to lead to a decline in reprint sales. (My cynical interpretation is that reprints are not about getting doctors to read complex research, which they simply don’t, but rather about associating a drug with the lustre of the brand of the major journal.)

The second part of the meeting discussed whether the very varied material on a particular topic might be brought together. Consider, for example, even a single randomised trial: there might be multiple publications, preprints, letters and rapid responses about the trial, the underlying data, the long submission to regulatory authorities, editorials commenting on the trial, systematic reviews incorporating it, videos about the trial, educational material, patient-oriented pieces, and multiple news reports. If the topic was not a single trial, but perhaps a drug, then there would be even more material.

There are in broad terms two ways that the material might be gathered together. One way would be to gather it all in one place, but that would be formidably expensive—and could easily become out of date minutes after it was completed, as new material emerged. The other way would be to thread the material together, but leave it at its original site. This could be achieved comparatively easily if everybody who produced material added compatible metadata—that is, signals attached to the material that showed what it was (a published study, a preprint, etc), who produced it, who funded the research, when it was produced, whether it had been updated, and much more. At the moment most such metadata is not available, making it impossible to thread all material.

But why would anybody want to gather all the material together? What, in other words, was the problem we were trying to solve? The meeting discussed this for some time, recognising that particularly with technology the world is littered with solutions that have no problems to solve. We agreed that for a patient, researcher, reviewer, or journalist it could be useful to have all the material together, and for a funder, including a pharmaceutical company, it would be good to be able to easily access all material related to research it had funded. There was also a hope expressed at the meeting that ensuring all material was available would increase trust in pharmaceutical companies.

At the moment, six major pharmaceutical companies are part of Open Pharma, along with six publishers—and the hope is that more may join and that the companies can work with public funders of research in improving the publishing of science.

Richard Smith was the editor of The BMJ until 2004.

Competing interest: RS has chaired meetings of Open Pharma and is paid for his time. He does not have a say in the policies adopted by Open Pharma, and this report is his own interpretation of the meeting. His time to write this blog was not paid. The meeting was held under Chatham House rules and so individuals have not been quoted. The Open Pharma website lists companies that have funded Open Pharma. BMJ contributed to the meeting, which was held in BMA House.