Mr. VOLKMER. Thank you very much, Dr. Raub. STATEMENT OF DR. DAVID A. BLAKE, ASSOCIATE DEAN FOR RESEARCH, JOHNS HOPKINS SCHOOL OF MEDICINE, BALTIMORE, MD Dr. BLAKE. Thank you very much, Mr. Chairman and subcommittee members. I appreciate the opportunity of sharing our views and practices on this subject of use of human byproducts in research. As requested by committee, staff, my written testimony begins with a review of what I have referred to as "the biotechnology revolution," and it contains many of the same points Mr. Reimers has already commented on, and so I will skip over most of that except to point out-and, I think, this is essential in appreciating the distinction between academic and perhaps industrial research-is that the biotechnology revolution of the 1970's, late 1970's, really took off with the Supreme Court decision to permit the patenting of new life forms. Heretofore, that was not possible. It is essential to understand that the basic research, for example, that led to the ability to do genetic engineering was, indeed, with bacteria and would probably have gotten on certain people's lists for sort of irrelevant research, and it was the discovery of the ability to manipulate the bacterial genome that really led to major developments in genetic engineering. The second important new technique really was not developed first in the United States but rather in England, that of the ability to make hybridoma cell lines that would be capable of a manufacture of monoclonal antibody. And that is an interesting case because there again, academic scientists interested in some very fundamental issues of how immunoglobulins were produced discovered this technique. There was no linkage with industry, there was no patenting. I spent a month last summer in England, and I can tell you many people there in the Government are very discouraged about the lack of economic development that was generated in the United Kingdom with this discovery in comparison to the economic development in the United States in association with genetic engineering. The basic research that led to these discoveries in the United States, as you know, was funded largely by the National Institutes of Health and the National Science Foundation. We in the university community needed to gear up in order to deal with the rapid discovery that began to take place as this new technology found practical application. But I would point out that the commercialization of university research is now new. I believe this is an inevitable stage in the maturation of a scientific field. Biology in Darwin's time was largely descriptive, and it remained so until perhaps the era of Watson & Crick's discovery of DNA and how it was able to encode the genes. Since that time, largely financed by Federal basic science research support, many practical applications have occurred. And I would cite chemistry and electronics as examples of academic fields which went through this commercialization stage much earlier, and perhaps it would be of interest to the committee at some point to talk to some of those people about how that occurred and what the parallels might be. While the university research is aimed at fundamental discovery, we recognize that there will be spinoff practical application. For the scientist, there are basically four choices: To pursue these practical applications in the university-and as you have already heard, that is fairly unlikely to happen because of the low priority given in universities to applied research. The second choice is to transfer the technology to industry, which I will comment on in a moment. Third, I guess, is to transfer himself to industry, and you have heard that that is a major route of industrial access to academic discovery, but it does tend to happen with the younger, more junior scientist. The fourth possibility, one, I think, that is most bothersome, is not to pursue these leads at all. And it is for that reason-and the failure for society to benefit in what they rightly should benefit from in terms of the fruits of fundamental Government-sponsored research-we for that reason have established patent and licensing offices to encourage technology transfer. The aim of this activity, in addition to technology transfer, is to obtain additional financial support for basic research, not personal gain or enlarged endowment. Now, I know people might view that statement with some cynicism, but I am willing to put my figures behind it. The Johns Hopkins University has never obtained more than $200,000 in royalty in any 1 year, and yet our research budget is $200 million. So there is a thousandfold difference, and one could hardly last long justifying a technology transfer office for purposes of enlarging the endowment at that rate. We do have a policy of retaining ownership of inventions in the university. The basis for that is to ensure diligent pursuit of inventions. We believe that that is a responsibility for the public trust, since most of this work was indeed supported by Federal funding. And we also have a royalty distribution policy which is based on the belief that all involved in creatively developing inventions should share in the financial rewards, and that includes the inventor, the department, and to a minor extent, the university. Let me turn now to the specific subject of this hearing, the procurement of human biological materials. The most common research materials obtained from humans are blood and tissue specimens. These are commonly obtained from patients but may also be obtained from nonpatient research subjects or blood donors. Informed consent is required if the material is being obtained solely for research purposes. Special consent is not required if the materials are waste specimens; that is, left over after pathology tests, although in most cases the patients sign hospital consent forms which advise them that these excess specimens may be used for research purposes. It should be appreciated that in the usual situation, the researcher does not know at the time the material is obtained that it will ever become a component of a technique or product which might have commercial value. Furthermore, in many instances, patient identifiers are not retained. These policies are routine and appear to be adequate. My final point is to the question of the rights of donors of research materials and the rights of researchers, and I would approach this in two cases. In the first case, where the researcher requests donation of blood or tissue for use in research but is unaware that the material will eventually be used for a commercially valuable purpose, it seems to me that the donor has no rights to a financial claim. The donation was made for research. Under U.S. patent laws, the researcher, referred to as "the inventor," has all legal rights to the invention, for it was he whose creative talents transformed the human material into something useful. The donor supplied the raw material. This is no different than the owner of a farm who sells a property to a developer who, in turn, builds houses and retains the profits without returning a share to the original owner. I recognize that a donation is not a sale, but I also am aware, as is this subcommittee, that the sale of organs and tissues is a complex legal matter currently receiving much attention. In any event, no deception was involved at the time of requesting the human material. Now let us turn to the second case, where the patient or research subject is known to possess removable materials having unique characteristics thought to have commercial value. In this case, the Federal regulations governing the protection of human subjects, 45 CFR 46, requires in section 46.116 that the informed consent include, and I quote, "an explanation of the purposes of the research, a description of any benefits to the subject or to others which may reasonably be expected from the research." Clearly, the research subject would have the right to know the commercial objectives prior to deciding whether to donate. Knowledge of this purpose would logically prompt some individuals to request higher financial remuneration than is usually offered. While I see no objection to the attempt to obtain a larger fee or a share of the royalty, I am concerned that such a transaction takes on the characteristics of a sale of tissue and blood and that the donor becomes a vendor who may be subject to product liability and warranty risks. These objective considerations, however, do not get to the essence of the problem: Trust. Clinical research cannot proceed without volunteers. The altruism fundamental to a decision to participate in clinical research is fostered by trust in and respect for the researcher. The fact that we are here today discussing this issue indicates that there are threats to this trust and respect. It would be unfortunate indeed if the exciting advances being made in the field of biotechnology as it relates to human health were to be dampened by a national sense that researchers and universities were profiting from the donations of research materials obtained deceptively from volunteers. While I believe that the current regulations governing informed consent should provide adequate protection, I also believe that the academic community needs to be totally open and honest about these matters. In the final analysis, it is the public trust that mat TESTIMONY presented before the SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT of the COMMITTEE ON SCIENCE AND TECHNOLOGY U.S. HOUSE OF REPRESENTATIVES on MARKETING OF HUMAN BIOLOGICAL PRODUCTS on October 29, 1985 by David A. Blake, Ph.D. Associate Dean for Research 720 Rutland Avenue Baltimore, Maryland 21205 |