Formulations and Phases
Back in ancient and wealthier times, I asked one of our Entremed luminaries what the most important issue was in bringing drugs to market. She said without hesitation that the most critical aspect is in choosing the right trials so that they yield results (this person also told me that we'd see Panzem as a drug well before the others, just because its oral formulation and lower cost make trials much easier to do).
The failure to achieve the Entremed vision so far has been a failure to hit sufficient results in the trials. The "new and improved Panzem liquid" is an attempt to get this right. First get bioavailability, and then go for effectiveness.
Most people believe that Endostatin was a big bust because it had disappointing results. I believe that if Dr. Folkman was given the opportunity to design the experiments and adjust dosages on a small number of patients, we would have seen the mouse results in humans years ago. Anybody want to defend kicking dying patients off the Endostatin trials?
Most people believe that the FDA is protecting us from bad acne creams. I believe that the long shadow of the FDA is killing a lot of people every day because of their inability to tell the difference between acne (USA deaths this week = 0) and cancer (USA deaths this week = 10,000).
The system is designed to punish those who swing for the fences. I'll not add my criticism to those who tried (with our full encouragement at the time, by the way).
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