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The Cell Game
Sam Waksal's Fast Money and False Promises--and the Fate of ImClone's Cancer Drug

Chapter One

Cancer Cells Are Smart

Six feet tall, trim, with white hair, a long-featured face, and intelligent hazel eyes, Dr. John Mendelsohn was one of the most accomplished cancer fighters in the world. He wasn't loud or physically imposing, but his fecund mind, forthright demeanor, and implacable resolve drew people to him naturally. The son of a traveling salesman from Cincinnati, Mendelsohn had proven himself a brilliant researcher and teacher, an exceptional administrator and fund-raiser. Yet he was not the kind who took his talents for granted. John Mendelsohn was driven to "use science to improve life."

One prize had eluded him, maddeningly, for over two decades: the commercialization of the monoclonal antibody C225, a potentially revolutionary cancer drug. C225, later called "Erbitux," was Mendelsohn's brainchild. It had alternately inspired and vexed him since 1980, when he and a small group of collaborators at the University of California, San Diego (UCSD), had made their earliest discoveries about "targeted treatment" cancer drugs. The lack of time and money had been their main constraints, as in most creative undertakings, but their novel ideas about how to fight cancer had also met with academic hostility and commercial resistance. Several times Mendelsohn had arranged deals with pharmaceutical companies to develop C225, only to have the agreement fall apart. He was quick to note that this is the nature of science, that developing new drugs is a risky and difficult business, that any worthwhile quest requires trial and error. "You haven't crossed home plate until you've crossed home plate," he'd say stoically.

Mendelsohn was convinced that C225 would one day extend the lives of many cancer victims, that it would be the most significant personal contribution he could make to the war on cancer. When he spoke of his campaign to bring the cancer drug C225 from idea to the laboratory to the marketplace and "get it into patients," Mendelsohn's voice would tighten, his brow would furrow, and his eyes would blaze intensely -- revealing for just a moment the steely determination that lay beneath his genial exterior.

At the end of May 2001, Mendelsohn, who was 64, was the guest of honor at a luncheon in New York City for more than 100 members of the nation's social and intellectual elite. The gathering was a fund-raiser for Houston's M. D. Anderson Cancer Center, the nation's largest cancer hospital, which Mendelsohn had run since 1996. The lunch was attended by President George H. W. Bush, a friend from Houston who sat on the board of visitors at the Anderson, and it was hosted by Martin Zweig, a Wall Street tycoon. Encompassing the entire top floor of the opulent Pierre Hotel, on 59th Street and Fifth Avenue, the Zweig apartment was like a castle in the sky: the walls were eclectically decorated with Renoir paintings, Beatles memorabilia, and the sparkling white dress Marilyn Monroe had worn to sing "Happy Birthday" to President Kennedy in 1962. Framed by its expansive windows were breathtaking views over the long greensward of Central Park and around the gray, crenellated cityscape of midtown Manhattan. As he stood in that fabulous aerie at the start of the new century, nibbling canapés, graciously accepting compliments and some $475,000 in donations for M. D. Anderson, no one could begrudge Mendelsohn his feelings of relief, fulfillment, and cautious optimism.

The week before, C225 had been the star of the 37th annual ASCO conference (American Society for Clinical Oncology), the largest gathering of cancer specialists in the world. There, ImClone Systems, Inc., the small Manhattan biotech firm that had licensed Mendelsohn's drug, had made a stunning announcement: in clinical trials, 22.5 percent of colon cancer patients who had used a cocktail of C225 and irinotecan, a standard chemotherapy, had responded positively, meaning their tumors shrank by more than fifty percent. This was the best response rate ever achieved in patients who previously had no hope for survival. The oncology community had reacted with a thundering ovation. There had been a burst of media coverage. ImClone's stock began to climb. And, to cap it all off, ImClone's CEO, Sam Waksal, had begun secret negotiations with the pharmaceutical giant Bristol-Myers Squibb for a landmark deal that finally promised to bring C225 to market.

Circulating in the noosphere of the Zweig apartment, Mendelsohn's gaze slipped out the window, and over the breathtaking views to fix on the bright, indefinite horizon. After all of the false starts and setbacks, he wondered, what could possibly go wrong now?

The history of modern biotechnology began on April 25, 1953, when James Watson and Francis Crick announced in the British journal Nature that they had unlocked the three-dimensional structure of the DNA (deoxyribonucleic acid) molecule. DNA is the "master molecule," the structure of which is encoded with the information needed to create and direct the chemical processes of life. The gracefully spiraled structure, known as the double helix, was the key to understanding the technology of life. Watson and Crick's discovery would earn them the Nobel Prize (Watson was only 34 years old at the time), and would raise many intriguing questions, foremost of which was: Could DNA be manipulated? Could life itself be manipulated?

It was a question, and a challenge, that would motivate an entire generation of scientists to produce some of the most exhilarating medical discoveries in history. It would also set off a philosophical debate: biotechnology was seen as either a Promethean quest to save mankind or a Faustian meddling. In his 1969 book about the discovery of DNA, The Coming of the Golden Age: A View of the End of Progress, Gunther Stent described man's ability to manipulate DNA as a sign of the end to social and economic evolution ...

The Cell Game
Sam Waksal's Fast Money and False Promises--and the Fate of ImClone's Cancer Drug. Copyright © by Alex Prud'homme. Reprinted by permission of HarperCollins Publishers, Inc. All rights reserved. Available now wherever books are sold.