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

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Harper Collins, Oct 13, 2009 - Business & Economics - 432 pages

"It began with a promising cancer drug, the brainchild of a gifted researcher, and grew into an insider trading scandal that ensnared one of America's most successful women. The story of ImClone Systems and its "miracle" cancer drug, Erbitux, is the quintessential business saga of the late 1990s. It's the story of big money and cutting-edgescience, celebrity, greed, and slipshod business practices; the story of biotech hype and hope and every kind of excess.

At the center of it all stands a single, enigmatic figure named Sam Waksal. A brilliant, mercurial, and desperate-to-be-liked entrepreneur, Waksal was addicted to the trappings of wealth and fame that accrued to a darling of the stock market and the overheated atmosphere of biotech IPOs. At the height of his stardom, Waksal hobnobbed with Martha Stewart in New York and Carl Icahn in the Hamptons, hosted parties at his fabulous art-filled loft, and was a fixture in the gossip columns. He promised that Erbitux would "change oncology," and would soon be making $1 billion a year.

But as Waksal partied late into the night, desperate cancer patients languished, waiting for his drug to come to market. When the FDA withheld approval of Erbitux, the charming scientist who had always stayed just one step ahead of bankruptcy panicked and desperately tried to cash in his stock before the bad news hit Wall Street.

Waksal is now in jail, the first of the Enron-era white-collar criminals to be sentenced. Yet his cancer drug has proved more durable than his evanescent profits. Erbitux remains promising, the leading example of a new way to fight cancer, and patients and investors hope it will be available soon.

 

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The cell game: Sam Waksal's fast money and false promises--and the fate of ImClone's cancer drug

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Sometimes, fact is far stranger than fiction. The rise and fall of ImClone is a dramatic example, starting with the story of its co-founders, Sam and Harlan Waksal; the "breakthrough" cancer drug ... Read full review

Contents

THE S2 BILLION ANTIBODY 1 Cancer Cells Are Smart
3
The Idea of the New
17
Family Business
42
The Miracle
67
Small and OneArmed
89
A Very HighRisk Opportunity
117
The S2 Billion Antibody
140
REFUSAL TO FILE
165
Inquiries
205
The Disconnect That Wouldnt Go Away
219
Who Knew What and When?
235
Coincidences Piling Up
261
In the Light of October
277
THE ONCE AND FUTURE MIRACLE DRUG
311
Epilogue
355
Notes
369

The Letter
167
We Screwed Up
185
CLINICAL TRIAL
203
Index
393
Copyright

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Page 360 - Every journalist who is not too stupid or too full of himself to notice what is going on knows that what he does is morally indefensible. He is a kind of confidence man, preying on people's vanity, ignorance, or loneliness, gaining their trust and betraying them without remorse.
Page 34 - The National Cancer Institute (NCI), part of the National Institutes of Health...
Page 302 - These flaws allowed a study of questionable quality to become the basis for fasttrack application. They allowed irresponsible hyping of a promising drug as FDA silently stood by — thus raising and dashing hopes of thousands of cancer patients. I am encouraged that since the June ImClone hearing, the FDA has reorganized pharmaceutical product reviews to enhance consistency and performance. This is a good first step and we are very interested to learn how FDA envisions this reorganization will improve...
Page 186 - These draft documents leave me most uncomfortable. They gloss over the seriousness of the RTF letter and make it appear that the integrity of the study results is not in question, when in fact it is.. .We will also need to rewrite major portions of the clinical and pharmacology part of the BLA including a new 9923 study report, new 141 (monotherapy) study report, new ISS and ISE based on these revised reports. I know that this is not what ImClone wants to tell their investors, but I think it represents...
Page 155 - He waved his hand in front of his face, as if to brush aside the complexities. "But for all that we're groping our way to the inner chambers. Like the King Tut people, eh?
Page 302 - ImClone. . . . \\'e have now learned that for years ImClone did not trust Sam Waksal with the company's corporate credit card. It actually installed special procedures to ensure he did not charge the company for his personal expenses. Why would ImClone management have trusted Dr. Waksal? The media have already reported his financial prohlems, and his past firings for allegedly misleading and even falsified scientific work.
Page 171 - the drug demonstrated remarkable success in causing colon cancer to regress in patients who had failed to respond to other treatments.

About the author (2009)

Alex Prud'homme is a writer living in Brooklyn, New York. His work has appeared in Vanity Fair, The New Yorker, the New York Times, Time, and People.

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