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Biotech / Medical : Imclone systems (IMCL)
IMCL 0.1590.0%Oct 5 5:00 PM EST

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To: 613 who wrote (2035)2/18/2002 1:20:37 PM
From: The Fox  Read Replies (1) of 2515
 
To the FDA...

This is outrageous!

thestreet.com

Cancer Experts Say ImClone's Tests Were Flawed

By Adam Feuerstein
Staff Reporter
02/15/2002 08:06 PM EST

"The Cancer Letter obtained a confidential copy of the clinical trial protocol, or plan, used by ImClone to conduct its
Erbitux study. It then asked the oncologists -- all experienced cancer drug researchers -- for their assessment, all of whom said the protocol shows the study was flawed from the very beginning."

It is possible that someone (or more than one person) in your organization is violating every tenet of ethical behavior. What's next? Are the actual patient records going to be published in The Cancer Letter? One looks first to the FDA as the source, or course, but the leak could just as well have come from NCI or a university participant in one of the FDA committees. Regardless of the source, the FDA has a vested interest in the matter and would, I think, be working to find and silence the mole. It is unbelievable that the leaks continue. If the FDA is at fault, your agency will destroy any credibility it once had with the Public.

Let the facts come out in the IMCL case...but let them come out through legal channels, in their entirety, so that individuals can view all of the data and make up their own minds.

The Fox

Also sent to congressman and senators
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