Correspondence
Secrecy in Research
N Engl J Med 1996; 335:134-136July 11, 1996
- Article
To the Editor:
Rosenberg (Feb. 8 issue)1 laments the increasing secrecy about methods and results in medical research. But if researchers are interested only in the search for truth, there is no reason for concealment in any kind of research, whether it is in medicine, mathematics, or any other field. There will always be a balance in research between the cooperative and the competitive drives; current political ideology and lack of money favor the competitive.
In the competition for funds, medical research has an advantage over many other fields in claiming that its goal is, to quote Rosenberg, “to prevent human suffering and premature death from disease.” We like to think this is our goal, but if this were the real intention of researchers, they would be better advised to divert the funds to the easily curable health care needs of the Third World, or even the inner cities of the First. In fact, most researchers have no real goal beyond what may be termed an unquenchable desire to understand. It is the need for money to reach that goal that drives the rhetoric of “saving humankind.” The increasing commercialization of research is responsible not only for making secrecy more common, but also for the misleading inflation of the end results of medical research.2
2 ReferencesNeville W. Goodman, D.Phil.
Southmead Hospital, Bristol BS10 5NB, United Kingdom1
Rosenberg SA . Secrecy in medical research. N Engl J Med 1996;334:392-394
Full Text | Web of Science | Medline2
Wadman M . Hyping results `could damage' gene therapy. Nature 1995;378:655-655
Web of Science | Medline
To the Editor:
Rosenberg recently described the concern that arises when commercial sponsorship of medical research creates pressures promoting secrecy in science. Investigators should be aware that there are circumstances in which avoiding the premature disclosure of new findings can ultimately expedite the transformation of a new discovery in the laboratory into a product useful in clinical practice.
Patent law requires that a new invention be “reduced to practice” before it can be patented — that is, either the invention must actually exist or there must be plausible evidence that it will function as described. A mere idea is not enough. At the same time, disclosing preliminary information about a new invention in a public forum such as a scientific meeting may be enough to make the invention unpatentable under the law, because the nature of the invention will be apparent to those knowledgeable in the field. Commercial sponsors almost never invest in the development of unpatentable products, because all their competitors will be able to market such products without incurring the cost of developing them. Investigators and research institutions rarely have the resources to develop a new invention into a commercializable product. Thus, even a promising discovery may languish on the shelf if premature disclosure has made it unpatentable.
Research contracts and licensing agreements with commercial sponsors can be drawn up in ways that protect inventors' and institutions' rights to inventions, limit the time during which information must be kept confidential, motivate the sponsor to expedite the development of clinically useful products, and provide for termination of the agreement if the company fails to meet benchmarks in product development or fulfill its financial obligations to the institution. Such measures can help speed the progress of a new development from the bench to the bedside. Investigators should consult with the research or technology-transfer offices at their institutions before disclosing information about inventions or making commitments to commercial sponsors.
James F. Burris, M.D.
Carol L. Tracy, J.D.
Georgetown University Medical Center, Washington, DC 20007To the Editor:
Temporary secrecy protects the investigator or investigators until their reward is secured through publication, patent protection, or some other legal documentation. The protection afforded by temporary secrecy may prove crucial to the success or survival of younger investigators, for whom scarce resources do not permit risking the loss of the benefits of a discovery. It will help reduce the negative effect of this transient secrecy if the time to publication by academic journals can be shortened, an improvement in the same vein as the provisional patent application adopted by the Patent and Trademark Office.
For research institutions, a certain amount of secrecy is also justifiable. If medical research is to be defined operationally as basic or clinical, or as serving to translate the one into the other, an increasing amount of basic research now has clinical implications for common diseases affecting large populations, and there is evidence that the transit from discovery to bedside is accelerating. The stakes entailed in a discovery become staggering, as are the resources required for making the discovery. Therefore, an increasing amount of secrecy becomes justifiable to institutions — for academic medical centers, to secure future allocations of resources, and for industrial firms, to secure optimal returns on their investment.
Thus, although it is seemingly unjustifiable at first glance on ethical and moral grounds, some secrecy in medical research may be helpful or even necessary for the sustained growth and preeminence of such research in this country. Although few were enthusiastic about the initial secrecy when the first successful polymerase chain reaction was accomplished, most would agree that the effect of that discovery on medicine and medical research is nevertheless tremendous.
Bing Lu, M.D.
Miriam Hospital, Providence, RI 02906Author/Editor Response
Dr. Rosenberg replies:
To the Editor: Dr. Goodman's views about the motivation of those who perform medical research is probably shared by many. Although scientific research is most often driven by curiosity and a “desire to understand,” there is an added dimension to medical research. To doctors, who are confronted daily with people suffering from diseases that cannot be treated adequately, and to scientists who have chosen to study such problems, research is more than an intellectual adventure. It is an attempt to solve problems that cause the suffering and premature death of innocent people. Some try to solve problems such as cancer, whereas others study problems such as hunger in the Third World. Open sharing of information and materials can be helpful in solving both types of problems.
Burris and Tracy and Lu make the important point that unless the findings of for-profit companies supporting biomedical research are protected, this important source of funding for research could diminish. The current patent laws are not ideal, however, and can inhibit the open sharing of information among research colleagues. Disclosing information at a public forum does not prevent it from being patented in the United States during the following year. And in the study by Blumenthal et al. in the same issue of the Journal, 1 56 percent of commercial firms report that “the research they support in universities often or sometimes results in information `that is kept confidential to protect its proprietary value beyond the time required to file a patent.' ”
I believe patent regulations can be formulated and ethical norms for scientific behavior established that provide for both the protection of intellectual property and cooperation among scientists. Working together, scientists and lawyers should be able to solve these problems. We would all be better off if they did.
1 ReferencesSteven A. Rosenberg, M.D., Ph.D.
National Cancer Institute, Bethesda, MD 208921
Blumenthal D ,Causino N ,Campbell E ,Louis KS . Relationships between academic institutions and industry in the life sciences -- an industry survey. N Engl J Med 1996;334:368-373
Full Text | Web of Science | Medline
