I'm assuming after reading your post that you feel I've unfairly characterized the bulk of the revisions in the latest consent form? Or you feel I've deliberately left out salient contextual information that favorably demonstrates telaprevir's performance? Presumably because you feel I "have it out for vertex"? Is that it? Because if so, that's just silly and patently false, I've done no such thing. And I'll be happy to respond to every one of your "points" to handily demonstrate that fact right now.
First off, I didn't make up any of the newly provided information above. It's information that was disclosed to me (and you) directly from Vertex, it's not secret, it's not lies, and it simply provides an ongoing update to the observed side effects and risks. It has been quoted precisely verbatim straight from the consent form. And it's information that is both new and not available anywhere else (that I'm aware of). If you don't like this information, or don't want to read it, or don't want others to read it...well, that's just too bad, isn't it? You should take your objections up with Vertex and the FDA - maybe they can censor your next consent form for you so you don't have to read anymore about your "soft testicles"? Secondly, the information I posted is meaningful to the prospective patients on this forum who are watching telaprevir and are very interested in the likelihood that it may be able to help them in the near future (especially the non-responders/relapsers who have significant fibrosis). Obviously a person in that position would be very interested in the latest disclosed information concerning risks, observed side effects and what is being done to ameliorate/counter those side effects. These factors also help to define how likely the drug is to gain FDA approval, yet another critical factor of interest to everyone waiting on this drug. The selective excerpted text I provided above provides just that very information.
As to your post and what you imply/claim I left out in an attempt to claim "the sky is falling"? Well, lets see what you've said here:
"Seems to me that Vertex have done the right thing here. They have included all the information gathered during the trial into the consent so that subjects are fully informed with the most recent verified information."
Vertex has the done the right thing here, who said they haven't? Oh I get it, what you mean is that Vertex shared this information with us purely out of the goodness of their own heart and NOT because they're legally required to disclose this information as dictated by the FDA? Is that it??
"It certainly paints a clearer picture of potential sides with combo SOC + VX950."
It certainly does, and that's precisely why I posted it - and your point is??
"There is more in the revised consent that mre chose to ignore. This includes:
- Group D subject who discontinue early for reasons other than non-responding will be given RNA follow-up tests and viral sequencing after completing telaprevir dosing."
Yeah, I chose to ignore this part. I left it out because I didn't think it was meaningful in the slightest to prospective patients looking for the latest info on telaprevir's effectiveness and side effect profile. And the reason for that is because it has absolutely *nothing* to do with telaprevir's effectiveness, nor side effect profile, nor likelihood to meet with FDA approval. You DO see that, right? Oh, and I also left it out because I didn't feel like typing/transcribing anymore than necessary (hope you don't mind?). Especially something that amounts to superfluous ****. But I can certainly see where you would think of someone as being a "chicken little" for omitting this devastatingly positive/significant information that Vertex has decided to continue to PCR test a participant after stopping early. Wait...no, actually I can't see that.
And incidentally I notice you're not actually quoting the text from the consent form. You don't disclose that in your post. You've actually streamlined and condensed your "quoted" excerpts, and intermingled your own bolstering verbiage without identifying it as such. That's a no no, don't you know that? Always best to meticulously quote with " " marks and quote precisely so people know they're reading exactly what was said and can distinguish where the author's "supplemental" content begins and the cited text ends. (as demonstrated in my original post) They teach you stuff like this in college. You went to college, right?
"- Group C or D subjects who relapse after the study dosing and are given off-study SOC treatment will also have RNA testing provided by the study during the off-study SOC. [The trial pays for the SOC drugs AND the SOC RNA assay]"
So what? This is nothing new and has been discussed many times here on this forum before. Plus, yet again, it has nothing to do with the side effect profile, risks and likelihood of FDA approval. And aside from that, you make it sound as if Vertex is being exceptionally benevolent by providing "free" RNA assays. Doesn't Vertex benefit from this data? Doesn't Vertex stand to make billions from this data? Aren't we test participants risking our life and limb by being the first to take substantial quantities of this experimental drug? It's a two way street here kilroy, don't make it sound like it isn't. And incidentally, although I'm almost certain follow up SOC and testing is free, how do you KNOW the RNA assays are all free based on your "quoted" excerpt above? It doesn't say that in the consent form under the section you're referencing.
"- In cases where rash is present, the study will include gene analysis designed to detect any changes in the genes associated with the immune cell genes, and enzyme analysis to detect any changes. They are looking for any sign of a patway that is causing a higher risk of rash."
Are you suggesting I haven't included this part in my original post??? Try reading it again maestro, because I've quoted everything precisely verbatim concerning this "excerpt" of yours. And once again, you're not quoting the text verbatim, you've condensed it and included your own interpretation without disclosing what part that is. I've included the entire verbatim text in context above - so your point here is?? I'm a "chicken little" because??
"These changes to the study appear designed to do two things:
- To identify and inform subjects of new iformation on sides gathered during the inital period of the trial
- To include additional lab analysis designed to indentify the source of the most significant sides, and to provide follow-up PCR free fo charge for subjects who quit before finishing the full treatment."
Once again you're making it appear as if this is an excerpt from the revised consent form. It isn't, it's APK personal comments. Also, once again the "free of charge" PCR's are not acts of selfless benevolence (nor are pertinent to side effects/FDA approval etc). This change/edit was made in response to some of the discussions they have been monitoring here. Specifically, my posts discussing how absurd it would be for Vertex to not track participants who dropped out of the trial due to adverse sides prior to completing their full (scheduled) course. After reading that potential scenario here (cited by me), they realized they had left out that contingency in the consent form and have subsequently added it in for that reason. So you can thank me for that addition APK, and Vertex (I know you're reading this), you're welcome. ;-)
"Just providing some balance to mre's Chicken Little cherry picking of the revised study design. Lets try to be objective, shall we?"
Oh yeah, you've really cleared everything up for us APK, thanks for that. And I'm real sorry to "cherry pick" only the meaningful information that people are actually *interested in* AND quoted it perfectly and completely. The stuff you added about PCR testing after stopping treatment has certainly "balanced" this grave situation. And you're so right, we all should strive for maximum objectivity at all times - thank goodness we have you as an example of that, huh??
Speaking of which, considering you've been silently sitting on this revised consent form which has all these latest, greatest, juiciest details regarding the trial results - why didn't YOU mention it?? Why didn't you explain/cite/quote what this new information was to everyone? That's damned curious that you didn't, but you sure have a keen interest in it now though, don't you? Is that an example of the "balance" and "objectivity" that you refer to above?
And one more thing APK - what was your EOT date again? Have you decided which one you're going to use from now on? Just thought I'd ask so I can scratch out the dates you're no longer using.
C20,21,22
http://www.medhelp.org/forums/hepatitis/messages/44838.html