Discussion in 'General ME/CFS News' started by Firestormm, Feb 16, 2013.
A pretty good article, aside from the horribly mangled/watered down description of PEM.
Don't read the comments section unless you're prepared to deal with unbelievable levels of ignorance, trolling, and prejudice. (At least, that was the case when I read through the comments Saturday. Maybe by now the bad comments have been buried.)
Wouldn't it be nice if it lasted only "days, weeks or even months".
I couldn't stomach some of the comments after the second page. Trolls.
However, and this is my opinion, while I think there could be a valid argument that for the people Ampligen has helped could be prescribed off label, I think we need to identify the subset of those Ampligen helps. But it's kind of a slippery slope in that it has helped others, yet the medication has side effects and there aren't any scientific studies at this time that show it works. So to that extent I am glad the FDA didn't approve the drug.
It's a gray area and there are no easy solutions. I feel sorry for those it has helped and won't have access to the medication but personally, I wouldn't take it until the science works this our.
I think the responsibility of blame lies with Hemispherx for doing shoddy research and thinking it will be overlooked by the FDA. The FDA has been accused to doing this.
You are factually incorrect.
There is published scientific data to show the benefits of Ampligen for people diagnosed with CFS.
Barbc, I have no interest in Ampligen as I don't think it would be an effective drug for me, but the statistics in that PLoS One paper are solid. That guy from thestreet.com has a degree in political science and appears to have an ax to grind with hemispherx biopharma. He clearly does not know how to read or report on a scientific journal article.
"Thisbenefit doesn't appear to be statistically significant, however. The study, as published inPLOS One, makes no mention of this intra-group comparison reaching statistical significance."
Table 1 of the paper gives the results of a paired t-test comparing whether the change from baseline is equal to zero within each treatment group p<0.001 (rintatolimod) and p=0.198 (placebo). The week 40 results for exercise tolerance comparing rintatolimod vs placebo were also statistically significant with an analysis of covariance model using the baseline scores as a covariate (p=0.047).
Hemispherx probably went wrong by reanalyzing existing data rather than running a new study and using the analysis published in PLoS One. There is however, absolutely nothing wrong statistically or design-wise with comparing each patient to their own baseline data - it's called a repeated measures or paired samples design.
You cannot cite anything from Adam Feuerstein. He has no expertise in the medical field but he is generally bearish on small cap pharma stocks and their drugs which makes sense as the majority of those fail and so he will always appear more right than wrong. He may or may not also have friends that short-sell said stocks before/upon his publications.
The study changed the endpoints, which I believe was a criticism of the PACE trial. The statistics compared individual differences and not group differences.
In my opinion and from what I do know about statistics, this makes the study problematic and further research is needed.
IMHO, a new study on Ampligen should combine it with appropriate antivirals, like valacyclovir.
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