Interview conducted by BusinessWeek magazine...discussing clinical trials, biotechs, and patients...and how it all comes together...what is the relationship of drug companies with the FDA and why do so many cancer drugs appear to fail are the topics covered...BD
Dr. Richard Pazdur, 55, is one of the most powerful men in medicine. An oncologist by training, he has overseen the U.S. Food & Drug Administration's cancer drug division since 1999, and in 2005 was named director of the FDA's newly created Office of Oncologic Drugs, giving him authority over the largest area of drug development. Consequently, Pazdur is a lightning rod for both criticism and praise in the cancer community every time a drug is approved or turned down.
"Drug companies are very good at developing drugs. We're asking them to do something different here, which is to develop a better understanding of the disease. Traditionally that has not been their major goal. But what we're looking at is a shift in the paradigm, an understanding of the disease process and how the drug works in relationship to that progress.
We have to have proof that a drug works. Its not: "Let's have a debate about whether the drug works." It's not: "Might the drug work?" The onus is on the sponsor to demonstrate that the drug works."
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