Replies to post #24824 on Amarin Corp Plc (AMRN)

[BioChica]

The problem is FDA all of the sudden decided because of a couple of drugs they tested, did not reduce CVE. Referencing drugs with poor track records in the first place! Common sense tells you, it is more complicated then just lowering trigs.

FDA has concluded Trigs under 500 are just hunky dory! The FDA, Dr. Coleman and Parks are traveling down a dangerous road! They may end up with eeg on their faces!

[nutsyprofessor]

"So, what if my levels are 499, 498, 497 . . . Then all is hunky dory??"

I thought like that too initially but then I realized how silly the statement was and here's why: every single biological marker that can be measured in a human being has a "normal range", that means theres a lower end number and an upper end number. Think about it. So, does that now mean that if your specific values are in the upper end of these ranges that you now have to take medication to bring them down to the middle of the range? Of course not! And so the same thing applies with TG's. Yes, I do understand that a TG level of 200-499 is considered high, but the issue is that no one really knows what is the true impact of "high" TG levels.

Here is a statement from the AHA:

The American Heart Association (AHA) recommends that a triglyceride level of 100 mg/dL (1.1 mmol/L) or lower is considered "optimal." The AHA says this optimal level would improve your heart health. However, the AHA doesn't recommend drug treatment to reach this level. Instead, for those trying to lower their triglycerides to this level, lifestyle changes such as diet, weight loss and physical activity are encouraged. That's because triglycerides usually respond well to dietary and lifestyle changes.


Here are some statements from the Mayo Clinic about TG's:

"Although it's unclear how, high triglycerides may contribute to hardening of the arteries or thickening of the artery walls (atherosclerosis) — which increases the risk of stroke, heart attack and heart disease. High triglycerides are often a sign of other conditions that increase the risk of heart disease and stroke as well, including obesity and metabolic syndrome — a cluster of conditions that includes too much fat around the waist, high blood pressure, high triglycerides, high blood sugar and abnormal cholesterol levels."

"Sometimes high triglycerides are a sign of poorly controlled type 2 diabetes, low levels of thyroid hormones (hypothyroidism), liver or kidney disease, or rare genetic conditions that affect how your body converts fat to energy. High triglycerides could also be a side effect of taking medications such as beta blockers, birth control pills, diuretics, steroids or the breast cancer drug tamoxifen."

...in other words, TG's could very well be nothing more than an "effect" of some underlying "cause" i.e. a Biomarker - biological measures of a biological state.

The point is that the FDA, nor anyone else, knows enough about TG's in the 200-499 mg/dl, to say that Vascepa should be approved for this indication because the natural repercussion of that decision will send a message to doctor's and patients that Vascepa can now be used to reduce my risks of CVD when in fact it may NOT reduce the risk. Also, this decision could also prevent doctor's and patients from prescribing and taking other medication that will actually reduce CVD.