In the United States the potential patient population for EPO was the some 400,000 individuals suffering from end-stage renal disease (ESRD). They underwent regular kidney dialysis, which depleted their red blood cells and left them with chronic anemia. Many required blood transfusions. By increasing patients’ red blood cell counts, EPO dramatically improved their lives. Once the Food and Drug Administration approved EPO, it would become standard treatment. And with payment for the drug underwritten by the federal government (which covered ESRD treatment under Medicare), the market was both large and profitable. As competitors came to realize just how valuable EPO would become, Amgen found itself embroiled in a patent lawsuit with Genetic Institute. This was resolved in Amgen’s favor. Subsequently, however, the company fell into a series of legal battles, remarkable for their duration and bitterness, with its business partner Johnson & Johnson.
In the fall of 1988, Rathmann called Binder into his office and unexpectedly announced, “Congratulations, Gordon. The board has elected you CEO.” The reasoning—that Rathmann wanted to cut back on work, that bringing in a fresh CEO on the eve of introducing Amgen’s first product would provide momentum—strikes one as partial and incomplete. One senior manager is quoted: “At first, there was a sense of panic over George’s leaving. But then we though, ‘Wait it’s OK—it’s Gordon. Always very reasonable, always willing to listen. We’re going to be all right.’” The trouble was, the new organizational structure called for Harry Hixon to become chief operating officer. Binder compares their tense relationship to “two porcupines mating.”
Binder calls the period from 1993-1996 Amgen’s “nuclear winter.” In the latter year, based on EPO and a drug to stimulate white blood cell growth, called Neupogen, the company’s revenues exceeded $2 billion. But Amgen failed to produce a major new drug during that bleak period, leading critics to say that its pipeline was dry and future uncertain. The greatest failure was leptin, a gene for a hormone that regulates body weight. When Amgen licensed the technology from Rockefeller University in 1994, The New York Times wrote that it could be the magic bullet for the weight loss market: “It could turn out that Amgen has bought a license to print money.” Leptin, to the company’s dismay, worked well enough in mice, but not in humans.
Reflecting on his years at Amgen, Binder ultimately suggests that the culture he fostered and the principles that inspired his managerial vision were less about science than a powerful moral compass. He recounts an incident in the 1990s, when Amgen’s management team debated whether or not to test EPO in infants who suffered from a rare form of anemia. Commercial logic argued against it. The market was tiny; the study would be costly; finding mothers willing to test their babies was difficult. At length, Dan Vapnek, the head of research, said, “We have to do this trial.” The patients needed the product, and pediatricians needed accurate information to know the right dosage. “I looked around the room,” Binder writes. “No one said a word. Decision made. . . . I was never prouder of Amgen than at that moment.”
With respect to his legacy, Binder quotes Kevin Sharer, who succeeded him in 2000 as CEO. “He was probably at his best when things were at their worst,” Sharer said. It’s no secret that in recent years, concerns about drug safety have roiled the biopharmaceutical industry and have tested Amgen’s management; Sharer recently called the year 2007 “the most difficult in our history.” Biotechnology, creating medicines modeled on human proteins, is undoubtedly the toughest, most complex business there is. As Binder shows, discoveries come by unexpected paths, the time horizons are long, the risks enormous. Yet there is no other path to the breakthroughs we demand. That finally is the moral of Science Lessons.
1 2





