Another One Bites the Dust

Part of my mission in life is to warn cancer patients about alleged "cures" that are built on deceptive claims rather than facts. Good cancer treatments are not a dime a dozen, and to prove that they really work requires long and costly clinical trials. It is so much easier to do some questionable test tube experiments and then announce the imminent end of the dread disease.

Many people associate these dubious "cures" with the worst kinds of "alternative medicine." But orthodox medicine should look in its own backyard. A case in point is Erbitux, manufactured by ImClone Systems of New York.

You may have heard of Erbitux under its former name, IMC-C225. In July, it was touted on cover of Business Week. The New York Times called it the "two billion dollar molecule." Wall Street stock analysts posted "buy" ratings and the stock soared. In 17 years, mind you, the company had never turned a profit and had just three million dollars in quarterly revenues. Yet, this fall, ImClone's capitalization reached $5.5 billion, more than many countries.

The company predicted that the Food and Drug Administration (FDA) would soon approve its application to market Erbitux. Yet, on December 28, they announced that the FDA had rejected its application. "In other words," James Surowiecki wrote in the New Yorker, "the agency would not even consider the drug for approval , much less approve it." (1/28/02)

But even worse news came a few days later. ImClone had apparently known all along that the FDA had serious questions about the way its clinical trials were designed and conducted. ImClone's stock started to head south. Shareholders started law suits and Congress began to investigate. The stock, which had topped $75 in December, headed for the basement. This Friday, ImClone announced that it was under scrutiny by securities regulators and the Justice Department as well. Its drop another 16 percent, to $16.50 per share.

So, how did ImClone get so big? Memorial Sloan-Kettering's Leonard Saltz, MD, supervised the clinical trials. Vincent DeVita, former director of the NCI, sat on the board, as did the drug's inventor, John Mendelsohn, president of M.D. Anderson Cancer Center. Dr. Mendelsohn is also on the board-and audit committee-of Enron. "It's a coincidence," he said last week.

In September, Bristol Myers Squibb bought 20 percent of ImClone for a billion dollars. Wall Street analysts relied on these big names for validation. "They didn't have much else to go on," said the New Yorker. "They couldn't examine ImClone's track record-it had none... So they looked to the reputational capital of the people who were telling the ImClone story."

The New Yorker aptly summarized the situation as "an arrogant, inexperienced biotech company with almost no revenues, pinning its hopes on a drug that no one on Wall Street could effectively evaluate." According to the magazine, DeVita and Mendelsohn "have a professional and financial stake in ImClone's success." Mendelsohn sold more than six million dollars' worth of ImClone stock in October. But "reputation is no substitute for knowledge."

I would suggest that the situation with Erbitux is not unique. FDA has been lax in approving many drugs based on scanty data. Phase III trials are practically a thing of the past, and radiation and surgery often get a free ride. It is rare that cancer treatments have been adequately documented through rigorous trials. Perhaps this latest fiasco will stir up the Congress and the media to do their jobs, and, looking beyond the flim-flam, demand hard data for the next "cure" that comes down the pike.

I continue to enjoy sprouting broccoli, radish and mung bean. But an astute readers reminded me that raw alfalfa and mung bean sprouts might not be so healthful. Experiments done in monkeys 20 years ago implicated L-Canavanine sulfate found in raw sprouts in a lupus-like condition. (Cooking eliminated the potential threat.) I would therefore suggest avoiding alfalfa sprout and cooking mung sprouts (as is routinely done in chow mein and other Asian dishes).

--Ralph W. Moss, Ph.D.