Public policy is created for a public purpose. The purpose at the heart of the Nelson Memo is unambiguous: the intended beneficiary of expanded public access is “the American public,” and the goal of such policies is to “allow all Americans to benefit from the returns on our research and development investments without delay.” Today, funding agencies, policy makers, publishers, universities, and other stakeholders are gripped with uncertainty about how best to translate the Nelson Memo’s call for expanded public access into coherent policy and workable business and service models. I wish to address a different question: Will we adequately achieve the public purpose of this policy guidance? And if, as I believe, we may not, then can we take this opportunity to address some of the most significant actual needs of the American public? Today, I focus on a use case familiar to many: the patient trying to learn about, and consider among treatment options for, a disease or medical condition.
This piece is drawn from a talk that I gave last week at a National Academies workshop. That workshop was intended to advise the Department of Health and Human Services about the public access policies that its constituent agencies will adopt as part of the Nelson Memo. These agencies — for example the NIH and FDA — include the principal biomedical research and regulatory bodies in the United States, so their policies will impact access for the American public to significant volumes of scientific, clinical, and public health research. My focus in this piece is therefore on biomedicine.
It is my contention that the outputs of biomedical research are not equally usable by all members of the American public. With the laudable increase in access to journal articles, it is now fairly simple to discover and access much of the biomedical literature. A simple search of Google or Google Scholar is enormously valuable for discovery. But that doesn’t make the biomedical literature usable to all. There are at least two reasons for this. For one, not everyone can establish the trustworthiness and authority of information resources, particularly given that we are awash in a sea of misinformation including on biomedical topics. And second, not everyone can distill or synthesize what they find into usable knowledge.
In using the biomedical literature, academic and professional researchers have numerous advantages that are worth stating plainly. They are the intended audience among authors for scientific writing and publications. They have knowledge of the field and of key research institutions and authors. They have knowledge of which publishers and journals are more trustworthy, selective, and high quality. They have expertise in critically reading the literature in their fields, the result of scientific and statistical literacies, among others. They have years of training in synthesizing what they find in order to apply it. And they have access to numerous specialized discovery and analysis tools. It is easy to take these advantages and others like them for granted, but they deeply shape the abilities of academic and professional researchers to use the biomedical literature.
Yet academic and professional researchers are not the intended beneficiaries of public access. As mentioned above, the Nelson Memo plainly states that the intended beneficiary is “the American public.” The American public is, understandably, typically not the intended audience of biomedical papers and publications. When members of the American public seek access to this literature, it is for other purposes, and unraveling the various particular use cases that exist is foundational to addressing them. One common use case, particularly with respect to biomedical literature, is as, or to advocate for, a patient trying to learn about, and consider among treatment options for, a disease or medical condition.
So many adults have had personal experience with this use case. Perhaps they have faced a complex medical decision, or someone they love has faced such a decision. Today, a common early step is to search the literature — through Google or Google Scholar — for information on the disease or condition, then try to read through the resulting articles from the biomedical literature.
If you have done this — as I have several times in recent years — it would be no surprise if you discovered dozens of scholarly articles on your disease or condition, and many more depending on the breadth of your search and the funding for research on that topic. And, having done this, it would also be little surprise if the items in this result set suggested a bevy of contradictory findings and recommendations. This is the biomedical literature: a conversation among scientists and clinicians, intended to build upon one another’s work and designed to stimulate future work.
Digging in, you might even find, as I did, a highly optimistic take on the least interventional approach possible, in the form of an article from a surgeon practicing in western China, presenting a case report drawn from half a dozen examples. No doubt such an article can be highly useful in presenting evidence and hypotheses from which future research studies and interventions could be developed. Without question such an article is utterly useless as guidance for a patient. Even worse than useless, it can lead to unrealistic expectations or undue doubts, undermining trust in the advice being offered by a medical professional. Stated plainly: The biomedical literature is not always directly useful to the American public. As I myself have experienced, access alone can cause confusion and even risk poor outcomes without interpretation or translation from someone who is medically and statistically literate.
My observations here are not intended to serve as an argument opposing open access. Some have argued that public access to the scientific literature will drive greater efficiencies into the research process, enabling more scientific progress to take place more quickly. Others find that public access influences patenting and therefore presumably can promote economic development. There can be many forms of return to the American public from public access.
Still, when the Department of Health and Human Services and its constituent agencies implement policy to achieve the public purpose to “allow all Americans to benefit from the returns on our research and development investments without delay,” they face a choice. Will they focus exclusively on enabling greater public access to the scientific literature they fund, with a mixture of benefits, limitations, and even risks? This is the call for action in the Nelson Memo, and it is the common policy action that can be taken across all federal funding agencies. But for different parts of the scientific literature, there are different use cases for the American public. Perhaps there is an opportunity, as agencies implement this policy guidance, to consider the needs that are specific to their own portions of the literature. In the case of agencies like the NIH and FDA, will they consider the use case of a patient trying to learn about, and consider among treatment options for, a disease or medical condition?
Perhaps we have seen comparatively little interest in this use case because it is the more complicated one to address. Many of the ideas that have taken hold are generally about what scientific publishers themselves can do, for example to enable researchers to provide annotation and translation of scientific articles, often through plain language summaries. But as I’ve argued, the very structure of the biomedical literature is not fit for purpose for patients and their advocates. What is needed is distillation and synthesis into formats that will be useful and situated within workflows that will be convenient, incorporating the medical literature and addressing misinformation, through whatever combination of expert human creation, curation, and artificial intelligence can be most effective. Addressing this need calls for action by those with broader mandates for or interests in supporting the needs of the American public, not least of which is the federal government.
Federal policy makers have spent several generations focusing on public access, showing the transformative impact of the policy making process. But to address the use case for patients and their advocates among the American public, and others that are specific to discrete portions of the federally funded literature, we would need not merely policy guidance and mandates but perhaps more importantly new service models and product categories, as well as the incentives necessary to motivate their development. How many more generations of policy making will it take to address these needs?