I read on a legal blog about 6 weeks ago (sorry I do not have the citation) that the FDA had convened a panel of experts to try to update the NCE decision process..This panel is independent of the CDER. The USPTO has had to amend its criteria for "novelty" because scientific progress has made it more and more difficult to find ideas that do not have prior art. To get around the "prior art" condition the PTA allows novelty for ideas emanating from prior art if the original inventors did not discover or note the effect or creation, and that the new invention is significant and not obvious..
If it were obvious then the discoverer would have patented it...so in my words it was not obvious...
they could switch from LOVAZA to VASCEPA immediately without loosing any revenue but with multiple advantages (better drug, bigger market and patent protection till 2030).
what would you do?
Sentiment: Strong Buy
2. What were the results?
Primary endpoint Fish oil Control p-value ARR NNT
all-cause death + non-fatal MI + non-fatal stroke 12.3% 14.6% .02 2.3% 43
CV death + non-fatal MI + non-fatal stroke 9.2% 11.4% .008 2.2% 45
All fatal events 8.3% 10.4% .02 2.1% 48
CV-deaths 4.8% 6.8% .02 2.0% 50
CHD death and non-fatal MI 6.9% 9.2% .02 2.3% 43
Fatal and nonfatal MI 1.9% 1.5% NS
Comparing data of vitamin E and placebo - no significant differences in composite outcomes, death and events.
There was no increased benefit of combining fish oil and vitamin E
3. Will the results help me?
* similar baseline diets (Mediterranean diet habits)
* 28% of fish oil patients stopped taking the drug by end of study
* 3.8% of fish oil patients D/C drug as a result of side effects
* no real change in lipid numbers from baseline
* limitation - open-label design
Conclusion: Long-term fish oil at 1 gram per day is effective at reducing death, mainly cardiovascular death. Essentially 22 out of 1000 patients at
low risk with LDL’s around 138 and normal triglycerides would benefit from taking fish oil. None would benefit from vitamin E or the addition of
vitamin E to fish oil. A month of fish oil would cost $.
Fish Oil Facts
* GISSI-Prevenzione Study in patients with CHD, the dose is 1 gm per day.
* To lower triglycerides, the dose is increased to 2 to 4 gm per day
Main Side Effect
* high doses might increase bleeding potential, especially those on aspirin and anticoagulants
google for : Early Protection Against Sudden Death by n-3 Polyunsaturated Fatty Acids After Myocardial Infarction