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Chapter 8
- State University of New York Press
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INTRODUCTION Chapter 7 examined potential benefits and harms to science resulting from DNA patents.This chapter continues this type of benefit-harm analysis in the medical realm. After reviewing the benefits of DNA patents for medicine, the chapter will examine the potential harms. This chapter, like the previous two chapters, will apply the Precautionary Principle to the issues at hand. It will examine potential harms to determine whether they represent plausible threats, and, if so, what would constitute a reasonable response to them. THE BENEFITS OF DNA PATENTS FOR MEDICINE, REVISITED Before discussing the potential harms to medicine that may be brought about by DNA patents, it will be useful to briefly review the potential benefits, since benefit/harm decisions must balance both benefits and harms. The potential benefits of DNA patents are all related to the effect that patents have on biomedical research, since research is essential to improvements in therapy (i.e., diagnosis, treatment, and prevention). Research includes basic research in fields such as genetics, genomics, proteomics, biochemistry, and microbiology, as well clinical and applied research in fields such as gene therapy, hematology , oncology, immunology, and endocrinology. Because researchers have been able to patent DNA only since 1976, and the biotechnology revolution began in the 1980s, most of the clinical and practical impacts of DNA patents will be realized in the future. 155 8 DNA Patents and Medicine Without a doubt, patents have played a major role in the development of clinical applications of genetics. Although the fruits of genetic medicine may not arrive for many years, we have already seen a substantial number of patents on gene therapy techniques, genetic tests, as well as drugs derived from genetic manipulation, such as Epogen and human clotting factors (Fons 2000; Pabst 1999; Baggot 1998; Leonard 1999). Although ethical and policy discussions have focused, for the most part, on patents on genetic tests, there have been far more patents on gene therapy procedures, methods, tools, and products (Caulfield and Gold 2000a,b). Many different companies are now sponsoring gene therapy clinical trials on diseases such as coronary artery disease , cancer, liver disease, hemophilia, and autoimmune diseases (Gura 2001). The Genetic Alliance, which represents over 300 patient advocacy groups for people with genetic diseases, supports DNA patents as a means of providing incentives for private companies to sponsor basic research and conduct clinical trials (Genetic Alliance 2000). Although the organization is not proindustry, it recognizes the importance of private investment and involvement in transferring technology from the laboratory to the clinical setting. It usually takes more than a decade as well as hundreds of millions of dollars to develop a new drug or medical device. In order to get a drug approved by the FDA, a company must obtain data from preclinical studies as well as clinical trials. Drug development is a very risky business: less than 30 percent of new drugs are profitable and very few drugs become blockbuster medications like Viagra or Prozac (Resnik 2001c; Goldhammer 2001). The American Medical Association (AMA) recognizes the potential benefits of patents for medicine, although it also recognizes potential harms. The organization supports policies that are designed to encourage progress in science and medicine while protecting researchers, clinicians, and patents from some of the potential pitfalls of private control of DNA (Council on Ethical and Judicial Affairs 1997). CASE STUDIES In order to understand some of the potential problems that DNA patents can create for clinical medicine, I will describe five cases that have raised ethical concerns. The Moore Case Although this case does not involve a patent on DNA, it is worth reviewing because it draws attention to some potential ethical problems in the patenting of biological materials. In 1976, John Moore contracted a rare form of cancer 156 Owning the Genome [54.156.48.192] Project MUSE (2024-03-29 08:02 GMT) known as hairy-cell leukemia and received treatment at the University of California , Los Angeles (UCLA) Medical Center. Dr. David Golde, Moore’s physician , recommended a splenectomy. Moore consented to the treatment. After his spleen was removed, Golde asked Moore to make several visits to the Medical Center, during which time Moore was asked to provide samples of blood, skin, bone marrow, and sperm. Golde told Moore that these samples were needed to monitor his health but did not tell him that he was gathering the samples to develop a cell line from Moore’s tissue. Golde was interested in Moore’s tissue because it was overproducing lymphokines...