tag:blogger.com,1999:blog-5472921328078253036.post8641101784332565162..comments2024-01-27T19:53:22.965-08:00Comments on Current Research into Cures for Type-1 Diabetes: Details of Dr. Faustman's Phase-I Results for BCGJoshua Levyhttp://www.blogger.com/profile/05300553471793001620noreply@blogger.comBlogger7125tag:blogger.com,1999:blog-5472921328078253036.post-52943230579948387082012-10-09T20:27:23.439-07:002012-10-09T20:27:23.439-07:00Also: remember that the idea that phase-I trials a...Also: remember that the idea that phase-I trials are only to measure safety, is wrong in two ways. <br /><br />First, phase-I trials almost always try to measure both safety and efficiency. Every now and then you'll see one which really is safety only, but it's rare. Most are both.<br /><br />Second, and more importantly, the phase-I as safety trial is only for new drugs. Drugs that are being tested for the first time. Obviously, BCG is the exact opposite of that. BCG is one of the most used treatments in the world (over 1 billion people dosed to date!) Last I checked, there were dozens of clinical trials using BCG active right now, and off all phases. So safety is clearly a non-issue. Even for type-1 diabetes specfically, I know of at least 6 studies that have already given BCG to people with type-1. <br /><br />No matter how you slice it: safety is just an excuse not to talk about effectiveness, because effectiveness failed.Joshua Levyhttps://www.blogger.com/profile/05300553471793001620noreply@blogger.comtag:blogger.com,1999:blog-5472921328078253036.post-9301242161692430962012-10-09T20:05:04.324-07:002012-10-09T20:05:04.324-07:00This study was not about safety at the start.
Th...This study was <b>not</b> about safety at the start. <br /><br />The ultimate proof that this trial is not primarily aimed at safety is the Clinical Trial record for it. Here is the section where Dr. Faustman describes what will be measured, and the safety implications:<br /><br />Primary Outcome Measures:<br />* concentration of autoreactive t-cells [ Time Frame: Measured weekly in first 8 weeks, then every other week for weeks 8-12 ] [ Designated as <b>safety issue: No</b> ]<br /><br />Secondary Outcome Measures:<br />* Concentration of TNF, TNF-receptors, other cytokines, and c-peptide levels [ Time Frame: Weekly for first 8 weeks, then every other week for weeks 8-12 ] [ Designated as <b>safety issue: No</b> ]<br /><br />That's the entire section. Notice that none of the measurements are listed as a safety issue. The official trial record number is NCT00607230, and you can see it here: http://www.clinicaltrials.gov/ct2/show/NCT00607230<br /><br />As for your evaluation of efficancy vs. establishing dosing, there is not difference. Think about it: establishing efficancy means establishing dosing, and visa-versa. Of course a study that fails it's efficency measures will also not know what dosing is needed. The reverse is also true: proving efficency means you will have established dosing.Joshua Levyhttps://www.blogger.com/profile/05300553471793001620noreply@blogger.comtag:blogger.com,1999:blog-5472921328078253036.post-34730742516389982682012-10-08T07:33:11.711-07:002012-10-08T07:33:11.711-07:00Joshua, I thought the purpose of this study's ...Joshua, I thought the purpose of this study's phase I is to measure safety. How can you evaluate efficacy when dosing has not been established?Shaun Tonstadhttps://www.blogger.com/profile/05819719375056862849noreply@blogger.comtag:blogger.com,1999:blog-5472921328078253036.post-83890334785622719072012-09-08T08:41:15.469-07:002012-09-08T08:41:15.469-07:00pdx_dc: I don't know how to organize that kind...pdx_dc: I don't know how to organize that kind of direct support. So I don't have any specific advice. However, if you (or anyone) does want to set something up, please tell me about it! I think that Dr. Zhao's work is very promising and deserves a lot of support. His timely results have earned it.<br /><br />Joshua LevyJoshua Levyhttps://www.blogger.com/profile/05300553471793001620noreply@blogger.comtag:blogger.com,1999:blog-5472921328078253036.post-41364815838484712612012-09-03T04:44:08.387-07:002012-09-03T04:44:08.387-07:00Fantastic post, detailed and critical, just the wa...Fantastic post, detailed and critical, just the way I like it. Thanks!Unknownhttps://www.blogger.com/profile/10283918645168494109noreply@blogger.comtag:blogger.com,1999:blog-5472921328078253036.post-33006451552069547132012-08-30T07:21:00.323-07:002012-08-30T07:21:00.323-07:00Thanks for the detailed review of this paper. also...Thanks for the detailed review of this paper. also for the link you posted on YDMV.net to Karmel's. I agree reading both is valuable.<br /><br />Most significantly I love the precedent of specific musical accompaniment to detailed blog post and your particular selection. I think you set a new gold standard for adding value to long and detailed blog post and I thing we should all follow in step. My only suggestion would be to like a spottily play list long enough to get through the whole post.<br /><br />Kudos my friend for the musical innovation and the post.<br /><br />BennetBennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-5472921328078253036.post-22175974868963403242012-08-29T13:29:33.262-07:002012-08-29T13:29:33.262-07:00Thanks for all the work, Joshua. I feel even the D...Thanks for all the work, Joshua. I feel even the Doctor herself is taking a step back and saying I dont have a cure but...<br /><br />I am wondering if "we" should all pitch in and see what we can do to help Dr. Zhao's research.<br /><br />How can the T1D community organize a grassroots movement to advance Dr. Zhao's work? PaviTravelStorieshttps://www.blogger.com/profile/08676668177724253687noreply@blogger.com