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Saturday, November 22, 2008
Pulse

2/12/04
Why Martha Stewart shouldn't have sold her drug stock
By Josh Fischman

Obviously, in hindsight reason No.  1 is that the diva of home decorating wouldn't be in court right now, defending herself against charges stemming from that ImClone stock sale, if she hadn't sold. But reason No.  2 is that the Food and Drug Administration today approved Erbitux, Imclone's cancer drug; it was the FDA's negative reaction to the drug two years ago that triggered ImClone stock troubles and, indirectly, Stewart's legal problems.

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But more studies have been done, and the FDA has decided that Erbitux is indeed a boon to advanced colon and rectal cancer patients whose disease has spread through their bodies. The drug is part of a new generation of targeted cancer therapies. It homes in on tumors that have a protein called HER-1, which plays a role in tumor growth. The drug shrinks tumors in some patients and delays tumor growth. It does not, however, extend patients' lives. But in patients who have failed other treatments, smaller tumors can mean fewer complications of the disease, which is the third most common cancer in the United States.

The FDA originally felt that the early Erbitux studies did not have enough information on the safety and efficacy of the drug. But a newer study does have that information, and ImClone also added some missing data to the early studies. This may have occurred too late to help Martha Stewart but not too late to help some desperately ill cancer patients.

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