When the disappointing six months results were announced in April, some of you may have wondered why the Lighthouse didn't comment or remove fish oil from the Treatment Now list. We were waiting for more results and/or a detailed reanalysis. Here they are:

[www.hdlighthouse.org]

This is good news. It does seem confusing to me.

Six months ago, when Amarin released the news of no benefit from Miraxion, one of the reasons postulated that they released the news early was to inform their investors or stockholders of the disappointing results.

Now the data seems to point in a different direction, likely beneficial to the company. The company's press release today states that an alternative statistical method (Positive Additional Analysis A longitudinal analysis) demonstrated statistical significance between the study groups at 3, 6, 9, and 12 months. I don't understand why the company would not have run the alternative statistical method at the six month end point to confirm the previously released "negative" study results.

Any thoughts?

Good news, regardless. Patience, easy to talk about, hard to maintain.

I've not used that statistical method before and need to read up on it but I think that it works like this. Imagine two groups that start out the same in a particular measurable category. Over time, the two groups diverge more and more. If you only measured at a particular early point, the differences may not be statistically significant. You've only got a certain number of people being measured and the small difference could just be a chance variation. If however, over a longer time period the differences continue to grow greater, the data in its entirety is statistically significant. In other words, if the differences are statistically significant at twelve months, then differences at nine months, six months, and three months take on new meaning.

I plan to talk to people at Amarin to get more information in the next couple of weeks.



Edited 1 time(s). Last edit at 11/19/2007 11:41AM by Marsha.

Thanks for info about the alternative statistical method and calling Amarin. It will be interesting to see their response.

Also, do other studies utilize this alternative method (Positive Additional Longitudinal A Analysis)? I think the name has a nice "ring" to it.

Tim

I wonder about Amarin as well.
My husband was involved in the trial for miraxion - he was on the trial for 12 months. The first 6 months no one in the trial knew whether they were on the "real drug" or on the placebo. The last 6 months, however, everyone was on the real drug.
After the year the results from the 7 on trial in Colorado where we drove 7 hours each 3 months were: 3 were worse, 3 didn't feel it did any good one way or the other and my husband thought either it was indifferent or he may have held ground but you don't know since you can't compare it with if you were not on the trial.
We contacted Colorado and they said they were discontinuing the trial due to no help to HD.
I wrote Amarin's CEO and asked if we could continue getting the drug from them and they said we would have to get it from where he did the trial, however, they said they found the results were not really positive so they would probably discontinue.
Thus, this article, which I have read also on the internet really makes be wonder if it is money.
I plan on emailing the CEO again and questioning the results.

I failed to mention on my previous post that we finished the 12 month trial this last March 2007 and I had written the CEO of Amarin about a month later.

Anyone wanting to read on the Amarin website, which is the company who
makes miraxion, can do so by going to www.amarincorp.com.