Free Republic

...FDA oncology drugs chief Richard Pazdur is the most important person in the U.S. government when it comes to cancer drugs, and he has never made a secret that he dislikes the accelerated approval process under which Iressa got the green light. Nor has he been shy about suggesting that the agency was railroaded in this drug's case. The truth is that Iressa-maker AstraZeneca simply refused to play by Dr. Pazdur's rules. In 2002 -- knowing it had plenty of data to qualify for accelerated approval -- the company rebuffed his requests for more trials and appealed directly to something...

<p>Who says the Swiss are cautious and boring? On Monday they moved decisively out of the neutral column on Erbitux, becoming the first nation on earth to approve the sale and marketing of the revolutionary new cancer drug.</p> <p>Expectations are that the United States and European Union will soon follow, or else watch as cancer refugees descend on Zurich and Geneva for what is obviously a safe and effective treatment. This is vindication for those who promoted the drug at and outside of ImClone, only to see its potential trampled in the media rush to condemn the stock sales of Martha Stewart and Sam Waksal. But any satisfaction is certainly tinged by the knowledge that the U.S. Food and Drug Administration passed up an opportunity to approve Erbitux nearly two years ago, and that tens of thousands of colorectal cancer victims have since died needlessly premature deaths.</p>

June 15, 2002 | 11:42 AM The Wacky Dr. Waksal by Frank DiGiacomo and Ian Blecher On Dec. 5, 2001, ImClone Systems, a biotech company that was seeking Food and Drug Administration approval for a promising anti-cancer drug called Erbitux, saw its stock peak at a price of $74 a share and begin an earthward trajectory. On the evening of Dec. 6, ImClone’s chief executive, Sam Waksal, 54, threw his annual Christmas party at the 5,000-square-foot Thompson Street loft that he calls home. Daily News owner Mort Zuckerman was in attendance, as well as former New York Times executive editor...