By any standard, Dr. Richard Pazdur's job as head of the FDA's cancer drug office involves a delicate balancing act. He is credited with setting a high standard for new oncology therapies, insisting that developers prove a new drug is beneficial, and he's helped make it easier for cancer patients to obtain experimental therapies.
In the end, as the New York Times makes clear in an in-depth profile, he's often vilified as an obstructionist by the people who are denied access to new drugs that don't pass muster. And the agency has been forced to post guards at advisory meetings to protect Pazdur and the committee.
"You can't win in this job," Dr. Pazdur said in an interview with the Times in his office. "If you approve a drug, they accuse you of lowering standards. And if you don't approve it, you're the worst thing since the Nazi death camps and should be killed."
It's not just patients who are frustrated, though. Developers have had plenty to grouse about as well. And the criticism has had an impact. The agency has proven willing to accept a single well controlled trial for approval -- instead of the standard two -- and cancer trials can involve only a relative handful of patients instead of the hundreds that are often demanded for other diseases. That flexibility has helped make cancer one of the most popular arenas for biotech companies, which are advancing 860 new cancer drugs in clinical trials.
- read the feature in the New York Times