GUEST EDITORIAL “Open-source” information for radiology

An interesting article appeared in The Economist Technology Quarterly on June 12, 2004, entitled “An Open-Source Shot in the Arm.”¹ This article brings to the public a concept that has recently been brewing in the scientific community. Although it spends much of its effort detailing the potential benefits and pitfalls for the use of “open-source” science for drug discovery, there are parallel considerations for the imaging community. The development of new software and equipment may be improved with this simple, but difficult to implement, concept.

Similar to the drug industry, manufacturers of equipment are seeking ways to take the risk out of the development process, which would subsequently lower the cost of bringing new products to the marketplace. This would potentially lead to the development of promising new tools for more limited markets. Today, if a new product does not have a return on investment in the tens or even hundreds of millions, then it frequently will not make it out of the investigative and development laboratories.

This is going to be particularly important for the development of new technologies that do not have a high price tag per unit, such as optical imaging instruments. A large manufacturer will not develop commercial products of this type unless it is comfortable with the potential for widespread application. This is why much of the optical innovations are coming from small companies. Perhaps even a better example is the development of promising imaging agents, especially those that target diseases that affect a small percentage of the population. This latter example directly parallels the problems raised in this article. In fact, the development of an imaging agent is frequently less interesting to the drug community than is a therapeutic drug.

The development of imaging agents and drugs is often synergistic. Imaging is increasingly being recognized as important for drug discovery and is being used by many of the major drug companies to shorten the investigation time needed to bring new compounds to the market. Most large pharmaceutical companies have developed relationships with academic centers for doing cellular or preclinical animal investigations using imaging to study new compounds.

The Economist Technology Quarterly article points out that the open-source model is a good way to produce software, as the example of Linux shows. The author then asks, “Could the same collaborative approach now revitalize medical research too?” A problem that might be immediately addressable with this approach is the scarcity of new drugs for diseases that are less widespread or for those diseases that mostly afflict poor people and thus are not supported by the traditional capitalistic drug development process. Perhaps a more interesting question to us might be: in what ways can the open-source method that is used so successfully for software development be applied to medicine in general and imaging in particular?

The article also provides examples of collaborative attempts in medicine that already exist. The sequencing of the human genome was an international open-source initiative—almost. It placed all the important data in the public domain, and individuals were not allowed to patent the results. The bioinformatics community often shares code and databases among limited partners that enable the development of pre-platform technologies. However, the major point of this article is to question: “can the open-source research be moved downstream, closer to the patient, where development costs are greater and potential benefits more direct?”

The article goes on to discuss one possible open-source approach for drug discovery to treat tropical diseases. A Web site would be established, and experts would volunteer to examine and annotate the shared database, and perform experiments. The results would be fully transparent and discussed in chat rooms. The research, at least initially, would be computational. The difference in this approach is that the researchers would be collaborating on the data and not simply sharing software or preclinical information. Grant support would be needed to supply the initial funds. Laboratory and preclinical animal studies might also be organized in this manner.

A more far-reaching proposal is the open-source clinical trial. To this end, a number of other initiatives by federal agencies, the American Medical Association, leading medical journals, and others are calling for the sharing of results, both positive and negative, from all clinical trials. There is a proposal to make a Clinical Trials Database that would include the results of all late-stage clinical drug trials, including those with both positive and negative outcomes. At issue here is a drug’s effectiveness, not its safety, which is well controlled by the FDA requirements.^2,3

All is not perfect, and the multiple reasons why the open-source methods used successfully for software development may not work for drug discovery are partially discussed in the Quarterly article. In addition, there is a recognized problem about who will pay for the cost of scientific publication. The open-source model depends upon payment by the author or a third party. The author-pay model is likely to lower overall quality as publishers may become willing to sacrifice quality for profit. The third-party answer may lead to a system that can be politically controlled, as noted by Fred Spilhaus⁴ in his letter to the editor in response to the above article. These issues have recently been addressed in an editorial by Robert Stanley⁵ in the American Journal of Roentgenology.

The fundamental question raised is: how can we better communicate our medical information for improving patient care? Ideally, all of the data on diagnosis and treatment for individuals would be entered into international databases accessible for online analysis so that subsequent results, both positive and negative, would be shared widely. While the technological capabilities for such endeavors continues to develop, many other issues—not the least of which are personal security and structured reporting—will have to be addressed before this can be even a partial reality. The ability to cross-link multiple scientific databases has already been shown to lead to new avenues for research and new forms of treatment. Imaging technology will play a major role at multiple levels in this process.