Biotech Values

[DewDiligence]

AMRN—Light liquid paraffin—the placebo used here—is not absorbed…

Apparently it is; from the Forbes story in #msg-144802741:

…what seriously bothered five of the six cardiologists I spoke to was that the mineral oil had not behaved as a placebo at all. In other studies of cardiovascular drugs, blood test results on placebo do not budge. That’s not what happened here.

Patients who received mineral oil saw their levels of low-density lipoprotein, the bad cholesterol, increase 10% to 84 milligrams per deciliter, 6% more than in the Vascepa group, according to the New England Journal of Medicine paper. What’s more, other blood test results used by cardiologists also went in the wrong direction. These changes were included in a supplement to the scientific paper, but not in the study itself.

Levels of c-reactive protein, a measure of inflammation that is used to help calculate heart risk by some doctors, increased from 2.1 milligrams per liter to 2.8 milligrams per liter, a 30% increase.

Could the placebo be causing some heart problems or strokes, making Vascepa look better than it really is? …Two top cardiologists say the placebo issue was enough to shift them from being excited about Vascepa to having doubt.

The Forbes article goes on to mention that Vascepa may have anti-inflammatory benefits that account for the better-than expected results of REDUCE-IT, in spite of the placebo issue discussed above.