It is specifically about the rise and fall of one Sam Waksal, oldest son of Jewish emigrants and Holocaust survivors, a man of irresistible charm, fabulous energy, and great intelligence, a man driven to success and the high life, a man who had bounced around academia without much success until in the 1980s he saw an opportunity to become a player in the cancer game, and, along with his younger brother Harlan, founded ImClone Systems, Inc.
It is also about an anticancer drug called Erbitux, originally known as C225 because it was the 225th drug tested by its discoverers, John Mendelsohn and Gordon Sato in 1980. It showed promise because in tests it stopped the growth of tumors in mice.
And finally it is a story about how drugs get discovered, how they are developed, and especially how they get approved (or not) by the Food and Drug Administration. And of course it is about the Byzantine and incestuous relationship that exists between that August government agency and the massive pharmaceutical industry.
The curious thing about all this is that Imclone never turned a profit, Erbitux never came to market, and most of the people associated with Waksal and ImClone either made out like bandits or got stuck holding the bag. The drug itself, which works against cancer tumors, particularly colon cancer, by cutting off the blood supply to the tumors (an "antiangiogenesis" drug), was touted as a miracle that would save the lives of innumerable patients and make possibly billions of dollars for ImClone.
At least this was the hype delivered by Sam Waksal, and bought hook, line and sinker by pharma giant Bristol-Myers Squibb, and by desperate cancer patients as well as salivating Wall Street investors who jumped on the bandwagon as ImClone's stock rocketed skyward. Because of the promise of the drug, Waksal himself was able to live his dream life as a New York socialite, throwing lavish parties for celebs (including Martha Stewart while he dated her daughter), collecting fine art, popping open $600 bottles of Chateau Lafite-Rothschild while secretly selling stock on the side, sending the proceeds overseas, buying expensive apartments and houses for himself, etc., etc.
But the cold hard facts of Erbitux, like those of almost any cancer drug one can name, are very far from the hype. As Prud'homme notes on pages 332-333, "these agents...[Erbitux and others like Avastin and Iressa] are remarkable scientific advances, [but] they still only benefit some 10 to 20 percent of patients, and they only extend patients' lives by a matter of months."
That's it. That's the bottom line. And yet these drugs are so valuable that the companies that end up selling them can make hundreds of millions if not billions of dollars.
Waksal apparently came to this understanding sometime during the early eighties. He realized first the simple fact that the way the cancer industry works is doctors have to prescribe something rather than nothing. Then he realized that living a few months longer can mean a lot to people. Therefore any FDA-approved cancer drug will automatically fill a need. What this means is that the PROMISE of a cancer drug, if cleverly promoted, will spark a rally in the shares of the company that owns the patent. If, like Sam Waksal, you own millions of those shares, you can get rich on mere promise alone.
Furthermore, should the drug have any real value at all, and be approved (or even look like it's going to be approved) by the FDA, you might be able to get some pharmaceutical giant like Bristol-Myers Squibb to front a whole lot of money on that promise since they are desperate to find a cancer drug to replace those that have gone generic.
This works because even drugs with very limited effectiveness are better than no drug at all. This is true for many patients, for many doctors, and is especially true for the big pharmaceutical companies.
Note that these drugs are valuable because the people who need them are typically people of relative means who can afford to pay large sums of money for them, either through their HMOs, their government, or their own funds. In contrast a drug that would prolong the life of poor people in third world countries would be of only marginal value to the big pharmaceutical companies.
I should also mention that Prud'homme spends some serious ink in this book on Waksal's long-time friend Martha Stewart and her troubles. Her personality, her empire, and the way she handles herself are vividly detailed. In fact, some readers might find her story the most interesting part of the book.
It is amazingly sad that all of this misery was so pointless because Erbitux has at last been approved. It almost certainly could have been approved earlier if the talented team at ImClone would have had a culture of discipline and getting things done and documented in ways that everyone knew the FDA required. If they had, all this pain and loss would never have occurred and Dr. Waksal would be a real hero instead of the one he only pretended to be.
Mr. Prud'homme writes with style and vitality. The book moves along well and has a great feel for keeping the story personal and emotionally accessible for the reader. We don't get overwhelmed with the scientific side of things, although it is always interesting to read about this emerging science and the wizards who are making it happen.
Sam Waksal, a scientist and business developer with a checkered past, lives a celebrity lifestyle, hanging out with the rich and famous, owning several fancy houses, driving fast cars, and heading a firm that is working on a cancer drug so promising that people with no other hope of treatment are flinging themselves at ImClone, begging for a merciful dose of "Erbitux."
The drug apparently does reverse inoperable tumors in a few test patients who had no other hope of living. Now the race is on to fast-track the drug through the FDA approval process based on the glowing clinical trials. But the FDA reviewer is unaccountably unencouraging when meeting with one of ImClone's top scientists. What is wrong? Is Erbitux, instead of being approved , instead going have its application refused? Why! And what will this mean for the high-flying ImClone stock?
The book reads like the best thriller, and author Alex Prud'homme is adept at making you feel like the proverbial fly-on-the-wall during the action. If you are at all interested in what happened behind the Martha Stewart debacle, you must read this. It's fantastic.
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.