The following appeared in Volume 98, Number 1 (Fall, 1998) of the APA Newsletters

This book is the joint effort of two different Washington think-tanks, the conservative American Enterprise Institute and the liberal Brookings Institute. The results of this collaborative effort are impressive: the book contains 15 essays written by 19 experts on the future of biomedical research. The book provides the reader with a balance of different opinions and views, and the authors represented in this collection have a great deal of insight and expertise when it comes to biomedical research policies.

Among this volume’s contributing authors are: Harold Varmus, Director of the National Institutes of Health (NIH); Bruce Alberts, President of the National Academy of Sciences; Purnell Choppin, President of the Howard Hughes Medical Institute; June O’Neill, Director of the Congressional Budget Office (CBO); Robert Helms, Assistant Secretary for Planning in the Department of Health and Human Services from 1981-1989; Arthur Kornberg, Nobel laureate and Professor of Biochemistry at Stanford University School of Medicine; Rebecca Eisenberg, Professor of Law at the University of Michigan School of Law; Philip Webre, senior analyst for the CBO; Frank Lichtenberg, a Professor of Business at Columbia University; Clarisa Long, a fellow at the American Enterprise Institute;and Richard Johnson, a practicing attorney who specializes in intellectual property issues.

Most of the authors in the book are concerned with issues relating to the sponsorship of biomedical research and development (R&D) in the future. These concerns are shaped by some key statistics concerning trends in R&D funding. The editors note that in 1997, the United States (US) spent over $36 billion for biomedical research. Although the federal government continues to be a key supporter of biomedical research and development (R&D), private industry now provides more support for R&D than the government: in 1997 industry funded 52 percent of US biomedical R&D, or $18.72 billion. Varmus notes that as recently as 1986, industry provided less than 36 percent US biomedical R&D funding.

O’Neill and Webre provide an overview of the place of biomedical research in the federal budget. Biomedical research is funded as part of the discretionary spending component of the federal budget. The NIH accounts for the lion’s share of the federal support for biomedical R&D. In 1997, the NIH budget amounted to $12.7 billion or 73 percent of federal biomedical R&D funds. According to O’Neill and Webre, under the 1998 budget resolution, discretionary outlays will increase only marginally by the year 2002, which will result in a decline of 11 percent in real dollars when one factors in inflation. Although the NIH budget has been growing by 6 to 7 percent per year for the last few years, fiscal and political realities will make it difficult to maintain this rate of increase.

(It is worth noting that O’Neill and Webre’s essay was written before the CBO announced that US will have a budget surplus in 1998, but this fact should not significantly affect their estimates about the 2002 federal budget, since thissurplus is likely to be short-lived. Republicans and Democrats are already dreaming up politically popular ways of spending this extra money.)

All of these key statistics point to the conclusion that biomedical research’s dependence on industrial funding will increase in the years to come. This is because private industry is likely to maintain or increase its funding of biomedical R&D while the government decreases its support for biomedical R&D. These economic realities raise some important ethical, legal, and political questions that the authors address in their essays:

1. How can we shore up federal support for biomedical R&D in an era of tight budgets?

2. Should the federal government support directed (or highly applied) research or basic research?

3. How can we safeguard openness in science if biomedical research becomes increasingly privatized?

In the remainder of this review, I will address these three questions.

Federal support of biomedical R&D has been relatively generous during this era of tight budgets, and it is likely that there will be continued political support for biomedical research. This is because people are willing to allocate money to cure diseases and improve health. However, this rationale for funding biomedical R&D is often viewed as only supporting applied research: if people want a cure for breast cancer, then they will be willing to fund research on breast cancer. The same point holds for research on AIDS, diabetes, heart disease, and other popular conditions.

But what happens to federal support for basic research if the public is only willing to fund applied R&D? Basic research does not have a great deal ofpopular appeal; people would much rather spend their money on the "disease of the month" than on basic research in cytology or genetics. The popularity of biomedical research is thus like a double-edged sword: it supports applied research on specific diseases but may undercut support for basic research.

Kornberg is very concerned about the funding of basic research in this era of tight budgets. First, he argues that progress in science sometimes occurs as a result of conducting basic research. He lists many examples of basic science discoveries leading to practical solutions in medicine: penicillin came from the study of bacteria, x-rays resulted from the study of vacuum tubes, and the polio vaccine was developed based on research on cell culturing. Second, Kornberg points out that directing research funds toward specific targets or "five year plans" sacrifices flexibility. According to Kornberg:

The best plan over many decades has been no plan. For lack of essential knowledge, timetables for assaults on particular diseases targets have had little meaning. Nor could we have anticipated the confrontations with novel diseases, such as AIDS, Legionnaires’ disease, septic shock, and drug-resistant tuberculosis (p.38).

Although I agree with the gist of Kornberg’s arguments for continued support of basic research, he overstates his case. First, although it is true that basic research sometimes leads to applications, it often does not. Although there are amazing cases of basic research generating practical results, there are cases where basic research generates few, if any, practical results. For example, we are still waiting to obtain significant benefits from research on somatic gene therapy, sociobiology, and animal pheremones. Of course, the evidence elicited thus far in this dispute is no more than fascinating tales and anecdotes. To get a goodunderstanding of the issue, we would need to do an extensive survey of the historical record on the practical payoffs of basic research. To my knowledge, we do yet have an historical survey that provides us with accurate data. In any case, the link between pure research and practical results is not as clear or direct as Kornberg thinks it is (Resnik 1998).

Second, even when basic research yields practical results, these results often occur many decades after the research has been conducted. For example, several decades transpired between the discovery of radiation and its use in the treatment of cancer. Sometimes we need quick solutions to applied problems and we don’t have the luxury of waiting for the results of basic research.

Third, while I agree that too much directed research leaves little room for flexibility, no planning at all can be irresponsible and wasteful. If funding organizations are to be held publicly accountable for their expenditures and outlays, then they need some plans for spending their money. This is what budgeting is all about. Furthermore, as Varmus points out, it is important to provide some stability for medical research funding to insure that projects can be funded for more than one year. Multi-year awards cannot be adequately supported without some long-term plans and goals.

Fourth, as Lichtenberg points out, although scientists believe very strongly in the importance of basic research, the public often does not share this view. The funding of scientific research is a privilege, not a right. To earn that privilege, scientists need to convince the public of the importance of their work. Politically sophisticated scientists know that in order to "sell" science, one must tout its practical value. In the politics of R&D funding, basic research rides on applied research’s coattails.

Thus, I side with Lichtenberg, who argues that there is room for government support of basic and applied research. Even if one accepts this position, there are still some important questions one needs to ask about how federal funds should be apportioned between basic and applied research. I would argue for strong federal support of basic research because private industry is likely to continue its support for applied research. Industry-sponsored research is conducted in order to make money, and as long as corporations can profit from their R&D investments, then they will continue to support research on applied science and technology.

However, corporations are less likely to invest in basic research, since basic research is not a profitable investment. Although applied research is likely to become more privatized, basic research may continue to require public support. If policies relating to federal support of biomedical research should take into account industry’s support of applied research, then the government should maintain a strong commitment to basic research in order to insure that enough basic research gets done. In economic terms, basic research should be viewed as a "public good." Just as the society benefits from roads, bridges, and public education, society also benefits from basic research (Resnik 1998).

The discussion of the privatization of research brings us to the final question mentioned above, viz., how can we safeguard openness when private industry supports research? Intellectual property laws in most Western nations allow corporations to control information through patents, copyrights, trademarks, and trade secrecy. These laws have been crafted in order to provide economic incentives and protections for private corporations, individual scientists, inventors, and entrepreneurs. By allowing individuals and corporationsto profit from research, these laws promote investments of time and money in science and technology.

Openness, or the sharing of scientific information, is important in research for several reasons (Resnik 1998). First, knowledge can be obtained more effectively when scientists work together instead of in isolation. The data gathered by one scientists may be helpful in another scientist’s work. The technique or tool developed by one research team can be a valuable to the entire research community. Second, openness plays a key role in scientific confirmation and peer review. The validation of scientific knowledge requires research to be subjected to public scrutiny and criticism, but this cannot take place when scientists do not share their findings. Errors and biases are less likely to be caught when research takes place under a veil of secrecy. Third, modern science is a social activity built on the cooperation and trust among different scientists, but secrecy can erode cooperation and trust in science.

But intellectual property rights often conflict with openness in science. First, it is possible for corporations to abuse the patent system. Patents laws are supposed to promote the sharing of information while protecting intellectual property rights. When governments award patents, the patent application (and sometimes other related materials) becomes available to the public. Inventors retain exclusive rights to produce the invention (or license others to do so), and the research community can learn about the invention’s design. Although inventors may refrain from sharing information about their creations while they are designing them, they are supposed to share this information when they apply for patents.

Corporations can foil the patent system by using it simply to controlscientific and technical information in order to gain a competitive advantage. One way to "game" the system is to take a long time to submit a patent application. While the invention is being developed, companies can refuse to share information. By the time they finally submit a patent application, the information may have lost a great deal of its scientific and commercial value. Companies can also receive patents and then refuse to produce their inventions or license others to do so. Companies may decide not to manufacture an invention in order to prevent competitors from using the invention or to prevent others companies from "reverse engineering" the invention to design a similar invention. All of these practices subvert the intent of patent laws since they allow companies to obtain patents with minimal sharing of useful information.

Second, corporations can control information by treating a piece of scientific and technical research as a trade secret. Companies are under no obligation to share trade secrets, and many companies use these secrets to gain a competitive advantage. If a piece of information becomes a trade secret, it may never reach the public domain. For instance, very few people know the formula for Coke and it has taken over a decade of litigation to expose secret research conducted by Tobacco companies.

In their essay, Long and Johnson discuss some problems and solutions concerning open communication in biomedical research. According to Long and Johnson:

The entire edifice of intellectual property rights is built around a simple dilemma: without legal protection, not enough information will be produced, but with legal protection not enough information will be used (p. 106).

In order to deal with potential abuse of the patent system, Long and Johnson suggest that we need to rethink the scope of patent protections, and they argue that patent offices need to make sure that they avoid granting rights that are too broad or too narrow. However, the authors do not provide any practical recommendations for revising our patent system.

Several other authors comment on the tension between openness and secrecy in the privatization of research. Eisenberg argues that in any reform of our intellectual property system we must be careful to avoid a "tragedy of the anti-commons," which can occur if we do not provide companies with economic incentives for developing and marketing products (pp. 122-3). However, Eisenberg also offers no practical solutions for avoiding this tragedy while safeguarding scientific openness.

While corporations that sponsor scientific research have a social responsibility to share scientific and technical information, it is idealistic to think that corporations will be swayed by moral arguments that appeal to social responsibility (Resnik 1998). We probably need to revise our intellectual property laws in order safeguard scientific openness. While The Future of Biomedical Research does not contain any explicit proposals for legal reform, it helps set forth some of the important scientific, moral, economic, and political arguments that pertain to these issues. These are important and difficult problems in science policy that require further study and discussion.