Big Government Stifles Biomedical Research

The National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) should make all federally funded biomedical and health research publicly available within six months of publication.

In recent years, the rate at which we translate basic biomedical discoveries into novel therapies has stagnated. In fact, despite a doubling of the federal budget for biomedical research and development, the number of new drug approvals fell from 53 in 1996 to 19 in 2009, and though 800,000 medical research papers helping to identify novel therapeutic targets were published in 2008, a paltry 21 new drugs found their way to the market. A recent study in the New England Journal of Medicine found that the primary contributor to this so-called “Valley of Death” is “the centralization of authority within large, inherently cautious bureaucracies in government, universities, foundations, and companies…[which] disregar[d]…the diversity of approaches that are necessary for innovation.” This hyper-centralization exists in part because scientists, physicians, and biotech entrepreneurs lack access to cutting-edge research developments and data -- currently monopolized by large research institutions in government, academia, and industry -- to materialize their ideas.

Recognizing the severity of this barrier, the NIH instituted a new public access policy in 2006, mandating that its grantees freely upload their research within 12 months of publication into a scientific journal. This year-long embargo, however, has proven too restrictive. As such, later that year, Senators John Cornyn (R-TX) and Joe Lieberman (D-CT) drafted bipartisan legislation -- the Federal Research Public Access Act (FR-PAA) -- to reduce this delay to 6 months. The legislation was reintroduced in 2010. An analogous bill in the House of Representatives has been co-sponsored by several members of Congress and supported by 120 different leaders in higher education. Yet significant progress has not been made with either legislation, and both remain distant from any meaningful chance of passage. Indeed, in direct opposition, the Fair Copyright in Research Works Act, introduced in the fall of 2008, aims to reverse the existing NIH open access policy entirely, barring any open access mandate. This legislative stalemate has led both open access initiatives to flounder in Congress thus far.

Analysis

A study published by an economist at Victoria University established that reducing the year-long open-access embargo, and thus implementing the provisions of FRPAA, would reap over $1 billion in benefits over the next 30 years due to the catalysis of innovation in the creation of novel drugs and medical treatments. This amounts to an eight-to-one rate of return. Furthermore, enacting a fuller open-access policy ensures that physicians -- most significantly those in rural areas -- would have access to the cutting-edge medical research they need to provide the highest quality of care.

Patients, too, could research the pathologies that plague them and their families, bolstering their ability to make informed medical decisions at the point of care. By incorporating this data into the existing PubMED database within six months of publication while making efforts to edu-

cate the public about the openly accessible nature of this database, the Obama administration can ensure that the data can be employed not only by patients and researchers, but also students and the general public. Though the common critique of open access policy attests to the need to preserve publishers’ copyright protections, the six-month time lag ensures that the publishers can maintain profit margins while prohibiting the medium-term inaccessibility of the data to students, patients, and researchers.

Next Steps

Considering that students, patients, physicians, biotechnology/pharmaceutical companies, and educators can all benefit tremendously from this initiative, it is important to unify these stakeholders in support for open access policy for biomedical research. Strong opposition, however, will be faced from the publishers’ lobby, which has been largely responsible for FRPAA’s stalling in Congress. The Obama administration and the Department of Health and Human Services should take on the mantle of halving the open access embargo, for which drafted legislation exists, while leveraging the best interests of community partners to stave off publisher opposition.