An Insider’s Look at the FDA

October 14, 2011
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If you’ve read my blogs for a while, or look up some past blogs, you’ll see I have been frustrated at times with the FDA. Yes, they have a tough job protecting us from medical products that are unsafe and/or ineffective. But when it comes to cancer, where we have few “homerun” therapies, I wish they were a bit more liberal. A “bunt single” might be good enough. You may have read how I have been critical of Dr.

If you’ve read my blogs for a while, or look up some past blogs, you’ll see I have been frustrated at times with the FDA. Yes, they have a tough job protecting us from medical products that are unsafe and/or ineffective. But when it comes to cancer, where we have few “homerun” therapies, I wish they were a bit more liberal. A “bunt single” might be good enough. You may have read how I have been critical of Dr. Rick Pazdur, the FDA leader for oncology drug approval. Some desperate patients and family members have referred to him as “Dr. No.”

Just the other day I interviewed a respected breast cancer survivor and patient advocate who has high respect for Dr. Pazdur. Musa Mayer of New York City is a 22-year breast cancer survivor and author of three books about breast cancer. She’s devoted her life to educating other patents about cancer and also playing a role in public policy. She has become a favorite patient representative on FDA cancer advisory boards and regularly weighs in when breast cancer drugs are being considered.

In my interview with Musa she explained how difficult it is for the FDA, how they must set the bar very high to maintain public trust and public safety. She says it costs drug companies hundreds of millions of dollars to get a drug through development, clinical trials and FDA review. The process does not move fast. Musa explains why. And she also explains why patients should not have false hope about clinical trials. She maintains their usefulness is to answer specific scientific questions but that seeing it as for sure that you will get “tomorrow’s medicine today” only creates false hope.

I asked Musa if she was optimistic that drugs could be approved faster, and therefore save and prolong more lives. She said yes. Her reason is that more drug companies are making sure there’s a diagnostic test to go along with their proposed new drug. That way the drug is used on the subset of patients who have the specific cancer variation where the drug works best. That kind of targeted therapy is what the FDA is looking for now and the right test, on the right patient, who is then treated with the right drug could present very positive results the FDA cannot ignore.

Maybe I am wrong about Dr. Pazdur, and maybe I’ve been unfair to the FDA. I’ll have to re-listen to the interview with Musa. She presents a convincing case. See what you think and let me know!

Wishing you and your family the best of health!

Andrew