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What was the FDA thinking?

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bluescribbler Donating Member (1000+ posts) Send PM | Profile | Ignore Wed May-06-09 10:46 AM
Original message
What was the FDA thinking?
Wife met with the oncologist yesterday. She had been in a clinical trial for a monoclonal antibody, MDX anti CTLA-4, for 2 1/2 years, but dropped out last year. Her reasoning was that her lung and breast mets were growing slowly, basically at the same rate as before she started the trial, increasing side fx, the rigamarole of frequent hospital visits and blood tests, (all required by the trial), and the docotor's opinion that the drug would soon be approved by the FDA, and she would be able to get it in a much simpler setting.

Unfortunately, since she dropped out of the trial, she has had mets to her brain. Perhaps she was getting some benefit from the drug, after all.

So she asked him about the drug's progress through the FDA approval bureaucracy. He said that it will likely be approved before fall, but here's the kicker. It will be approved for use with chemotherapy. The drug has been tested on approximately 8000 patients, none of whom were doing concurrent chemo, so noone has the slightest idea how the drugs will interact, but the FDA is saying, if you want CTLA-4, you have to do chemo as well. :mad: Doc says it's bad science, and I totally agree. :wtf:
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LeighAnn Donating Member (1000+ posts) Send PM | Profile | Ignore Sat May-16-09 10:33 PM
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1. Yep. I hate that
That's a shame when bureaucrats tie the hands of physicians who know better.

I hope your wife is doing okay, and that her oncology team can find something else effective.

~*Peace*~
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Forkboy Donating Member (1000+ posts) Send PM | Profile | Ignore Sun May-17-09 03:05 AM
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2. That's just sucky.
I'm sorry, man. That's not right at all. :(

Best wishes to your wife.
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