HDG...
"What is the "New Science", proves TG reduction decreases CVE?"
Ah "that is the Question"
Shakespeare
OK..Let's establish parameters..The first is the question is not a mathematical proof which would not be open to opinion. The speed of light does not need the defense of opinions.
Very crucial to the question is was the "New Science" used by the FDA to rescind the SPA, valid. The idea behind the SPA is to put FDA and the sponsor on a more even level. The FDA's decision in rescinding the SPA was unilateral and the theory of contracts is that both partners are allowed to express their opinion and if there is a serious disagreement, then the case can be taken before a neutral arbitrator (eg. the courts) for dispute resolution. In this case the FDA is acting as both a combatant and the arbitrator. They have also managed to trample Amarin's rights by a well devised stalling technique which the federal courts ought to take a look at as it clearly violates constitutional right to speedy trial.
New science?? The question does lowering trigs lower CVD risk is controversial. Supporting evidence suggests trig lowering should lower CVD risk simply because trigs are part of the non HDL-C lipid fraction and the literature says that non-HDL-C is a better predictor of CVD risk than LDL-C. Trig levels also effect the configuration of LDL-C and higher trig levels move the particles toward the small dense variety which raises LDL-P. LDL-P is considered the best predictor of CVD risk.
On the other side, skeptics say trigs are not independent predictors of CVD risk if you factor in non HDL-C...This is the kind of nonsense argument that suggest there are too many English majors in medicine and not enough science majors.
So the question is really not about "New Science", because the SPA rescission decision was not about "New Science". If there was truly new science then Amarin would have been forced to agree...something that has not happened. Entering the SPA agreement both sides understood the trig question was controversial. If the answer were known, then what could be the rationale for running REDUCE-IT. To cancel the SPA in a manner that would hold up in a neutral court, the FDA would have had to introduce evidence that trig lowering would not lower CVD risk...Something they attempted in their pathetic "three Trig Study" presentation. Their argument was absurd.
So the SPA was rescinded without meeting the New Science bar. They simply used their authority. This really was nothing different than a school bully taking another kid's lunch money. So the FDA was free to make its own determination, and now it is equally free to change its mind..New Science is not a mathematical term...We know from bitter experience, that New Science is what the FDA says it is...
Everything boils down to Aesop's Fables...
"The Fox, the wolf and the lion"
A fox a wolf and a lion have killed a deer and the lion asks the wolf to divide the carcass up between the three. The wolf carefully divides the the meat into three equal portions. At this point the lion jumps on the wolf and kills him. The lion then turns to the fox and asks him to divide the kill. The fox gives himself a tiny portion of the meat, and the rest to the lion. After eating the lion asks the fox how he learned to divide up the spoils so well. The Fox answered.."I learned it from the dead wolf".
":>) JL
