Cancer in rats is Pre-phase 1. Then there is phase 1 to establish dosage in humans!! Of course, there is phase II/III.
"In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use."
THERE IS NO 2nd PHASE TO RE-ADDRESS PRE-phase 1/NO DRUG WOULD BE MARKETED
- I quit a PhD program because there were too many morons complaining that there was nobody left in science who was innovative--all the while advocating conformity through every aspect of education/publication/research. This is what happened at the review yesterday, plus ego. Scientist are educated but when there is an "unknown" the old adage that scientists have no "street smarts" comes into play. If these people haven't been taught what to say and do they freeze. Most of the panelists who were outspoken and became involved in the discussion (from what I saw) voted "yes". The others voted "no" because they were confused and thought others were going to vote "no".
--The comment that heart VP wasn't a concern but method was questioned was naive and ignorant given the setting/context. It sparked a lengthy debate that had no merit. It was the WRONG time/place to debate the principle of practice, and was ego ("I could have done it better"). Arena should have shut down the discussion immediately by stating,
"you are correct, big pat on the back, let's move on".
The higher I went in science the more I became dissapointed by the arrogance and lack of intelligence. These people are NOT as special as they think! They are mostly priveleged people who got an education. They fall into the 80% statistical grouping for intelligence. Eighty percent of the population could achieve the same education given the same opportunity.
Education prepares you to solve problems that have already been solved. True intelligence and creativity is required to solve the new ones. We do not foster or develop thinking in our schools. We are too tied up in memorizing things that are assumed to be facts.
"Education prepares you to solve problems that have already been solved."
--Bingo!! In many fields that is great. In science that is a fundamental FLAW! The "mad scientist" with all his/her innovation is a thing of the past. Science is now run like a training program where conformity is king. Any person pursuing science for the sake of knowledge is taken advantage of and stolen from. Only those willing to sell their sole to have their name as the leading author on the scoop of another, and to get the shrinking $$ for reaearch will survive.
I'm done. Good luck!
"Will the truth overcome"?
It usually does, but science is plagued more than ever by what John Locke stated, "New opinions are always suspected, and usually opposed, without anyother reason but because they are not already common."
Think about this: about 50 yrs ago Thalidomide caused terrible defects in babies born to woman who took a drug to ease morning sickness. Now, an anologue is marketed by Celgene. I KNOW with every ounce of logic that I possess that Thalidomid would not be approved today. It was approved about 10 yrs ago and is a tremendous treatment for multiple cancer types.
I'm not comparing its effect to a weight loss drug, but the ideology is changed that a small co. bringing a controversial drug (pretty much all) has a tough road "if for no other reason than it is not already common", and nobody is paid off.
Yes, I like the his or her wealth of information as well, but what can anyone of us do in this regard, contact and complain to the SEC but would this Agency understand science if the FDA and the Panalist cannot?
Good will overcome Evil someday soon!