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C h A p t e r F I v e Epo The Making of the Biotech Blockbuster Throughout this book we have explored the active roles university biologists played, during the early days of biotech, in shaping a wider social environment favorable to commercial molecular genetics. In the last chapter we saw how they helped create an overheated investment market for shares in the small biotech firms they founded, and how the hype spilled over into medical overenthusiasm for recombinant interferon use (largely through the marketing clout of the big pharmaceutical partners to biotech firms, to be sure). In this chapter we look at the cloning race that—by capitalizing on a large body of preexisting publicly funded biological knowledge, as usual—brought to market the most profitable, most widely used blockbuster drug ever to come from recombinant DNA biotechnology : erythropoietin, better known as Epo. As we shall see, like interferon alpha, erythropoietin was a valuable contribution to medicine, but was vastly oversold, and this time with catastrophic results. But here we move our focus from how biologists and their corporate allies shaped financial and medical markets to how they shaped the legal reward system for their work. Specifically we explore the part played by biologists, in their labs and as expert witnesses and as represented by the biotech firms they launched, in the lawsuits that established the patent regime protecting first-generation recombinant drugs. We look at how these lawsuits rebounded on the biologists, through the way the US federal courts defined the boundaries of defensible patents in the Epo lawsuits so as to reward and incentivise certain kinds of commercial molecular biology research and not other kinds, thus setting future research agendas for biotech drug development. We also look at the role of some leading biotech firms, their credibility underwritten by their scientists, founders, and scientific board members, in securing a further government-sponsored monopoly for lucrative recombinant drugs, beyond patents, through the well- 132 Gene Jockeys meaning Orphan Drug law. Thus in the late 1980s and early 1990s the courts and legislature again became arenas in which biologists strove to impress the public with the value of their work in making drugs through molecular genetics , pleading that their efforts be showered with extraordinary rewards—and in ways that particularly favoured certain factions among them. The ultimate consequences raise questions about whether society might be better served by a different incentive scheme. Hormone of High Living As doctors, aviators, and athletes have long appreciated, life at high altitudes increases the body’s breathing efficiency. From the end of the nineteenth century , physiologists understood that this adaptation involved an increase in red blood cells and debated whether low oxygen stimulated the production of red blood cells directly or via a hormone. In the 1950s, Yale physiologists were finally able to show that it was a hormone: something in the blood plasma from anemic rabbits made normal rabbits boost their red blood cell counts.1 In the Chicago laboratory of medical researcher Leon Jacobsen, a Manhattan Project veteran who studied radiation sickness and recovery with funding from the Atomic Energy Commission and NIH, the circulating hormone was traced to the kidney. One of Jacobsen’s students, biochemist Eugene Goldwasser , continued the project of studying this hormone (dubbed erythropoietin, meaning “creator of red blood cells”) at Chicago for his entire career. Sourcing large quantities of anemic sheep plasma from Armour Pharmaceuticals, which had been become a major hormone manufacturer in the interwar years by tapping the wastes from the parent company’s slaughterhouses, Goldwasser had by the early 1970s become the world’s leading Epo expert. Goldwasser determined the molecular weight of sheep erythropoietin and that it was a glycosylated protein —that is, it was decorated with sugar molecules at specific positions along the amino acid chain—but he was not able to purify enough for more detailed chemical or structural analysis. One of Goldwasser’s major contributions was to improve assays to measure Epo levels based on the reactions of living animals or cell cultures; these bioassays showed that the protein had effects that differed somewhat depending on the source species and the species in which it was tested, unlike insulin but rather like growth hormone and interferons.2 Presumably, then, medically useful Epo would have to be derived from humans. Medical prospects for Epo brightened in mid-1970s with the discovery that the hormone could be extracted from the urine of anemic people. To supply American scientists the...

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