Monday, January 07, 2013 2:24:31 PM
The converstaion on PPHM has been hijacked numerous times by folks comparing apples to oranges and getting waaaay too technical. Sure, the FDA has issues with drug trials advancing where the benefits are outweighed by the risks. A drug that potentially helps with depression, but raises blood pressure or causes heart problems. That's a risk the FDA must address. A drug that might improve survival in people with cancer that are expected to live 5 months anyway. It's a no-brainer. Especially if there is data to show it is safe and effective. Many cancer trials have been advanced to ph III where the drug didn't show much, if any efficacy but it was somewhat safe (though not always safe). The risk is with the drug company that is betting it's money that the ph III trial will produce approvable results. Ignore all of the inevitable hr, p number, stat sig stuff that is sure to come. All IMO.
Regards,
WH
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