Biotech Values

[rfj1862]

Dew,

While I certainly don't think there is a conspiracy here, I do think that Herper and Fuerstein desperately want to be "right" about Amarin.

Presumably both had access to the data before the presentation. What data did they have access to? If it was the full publication, what they just did amounts to journalistic malpractice, as they focused very tightly on a few potential shortcomings of the trial without examining how these were addressed with different prespecified analyses.

As far as Herper interviewing people for his article: Did they have access to the data? I don't think they did have access to the full publication. I can get any answer I want simply by changing how I phrase the question.

Then there's Nissen, who said:

On the log-transform hsCRP analysis, Nissen said, the data in the manuscript that show a large increase of CRP with the mineral oil placebo "is the 'official' result. Mineral oil is probably pro-inflammatory, which is a major problem with the trial."

Which of course we know is not true, as the log-transform analysis was prespecified. And of course Nissen is being disingenuous because he knows damn well that log-transform is the correct way to analyze the data. And, of course, journalists are interviewing a guy who is running a competing trial.

And then you have the guy freaking out on twitter about one adverse event, AF, that was marginally higher in the treatment group than the placebo group, without any increase in risk for downstream events. Statins, niacin, etc all have endless lists of AEs that are more common than placebo, some quite serious.

I think a lot of KOLs either have their ego wrapped up in this or, like Nissen, are heavily conflicted. Same thing goes with the two "reporters" who were highly negative. I don't have a problem with them reporting what they feel is negative information, but it shows a lack of integrity to not also report on how it was addressed.

To me it makes little difference to my overall portfolio if this goes up or down; however, it is a little tragic that egos are getting in the way of a relatively inexpensive, potentially life-saving product whose efficacy and safety is supported by a very well designed and conducted clinical study. If the bar to other therapies was as high as it apparently is for Vascepa, we wouldn't have any antihypertensives newer than diuretics, nor would we have any diabetes medications beyond metformin.

Quote:
AMRN—…the Forbes guy [Matt Herper] is *really* digging to find reasons to doubt the result but not doing any digging whatsoever to see what measures were taken to address these issues… I also find it a little disturbing that he is presenting a trivial increase in LDL-C in the placebo arm as something to be highly concerned about.
I’ll concede that there may be modest bias against REDUCE-IT among some of the top biotech people I follow on Twitter insofar as few, if any, of them predicted success. The former head of R&D for a Big Pharma (and someone I follow on Twitter) told me this in August:
Quote:
I have no real scientific evidence, just observations over the years. Getting a positive CVOT result is a big hurdle. Fish oil to date has been uninspiring. Niacin (which admittedly has multiple effects) also doesn't have a CVOT benefit. Would a high dose "super fish oil" suddenly work? Maybe. But I wouldn't bet on it.
However, I wouldn’t knock Matt Herper, who is one of the best biotech beat writers. Matt doesn’t scrutinize technical papers on his own; rather, he calls experts in the field for comment, as he did in this instance. Some of the posters on the AMRN iHub board are going wacko with their accusations against Matt and others.