Comments on: Start Me Up http://scienceprogress.org/2008/09/start-me-up/ Tue, 13 Sep 2011 13:59:48 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: Ann Marie Saidy http://scienceprogress.org/2008/09/start-me-up/comment-page-1/#comment-3255 Ann Marie Saidy Fri, 31 Oct 2008 14:41:27 +0000 http://www.scienceprogress.org/2008/09/start-me-up/#comment-3255 Thank you for this valuable information and very valuable, thoughtful comments. Don't we need a data base of people who have been treated wtih stem cell medicine that could serve as a guide for future researchers and the FDA? Ann Marie Saidy Thank you for this valuable information and very valuable, thoughtful comments. Don’t we need a data base of people who have been treated wtih stem cell medicine that could serve as a guide for future researchers and the FDA?

Ann Marie Saidy

]]> By: Kelly Imlay http://scienceprogress.org/2008/09/start-me-up/comment-page-1/#comment-3114 Kelly Imlay Sat, 11 Oct 2008 18:04:37 +0000 http://www.scienceprogress.org/2008/09/start-me-up/#comment-3114 Do you know of any publications about Stem Cell Progress as I would like to be on a mailing list. I am the caretaker of a gentleman who had stem-cell treatment in July 2008. Kind Regards Kelly Imlay Do you know of any publications about Stem Cell Progress as I would like to be on a mailing list. I am the caretaker of a gentleman who had stem-cell treatment in
July 2008. Kind Regards Kelly Imlay

]]> By: Jesse Reynolds http://scienceprogress.org/2008/09/start-me-up/comment-page-1/#comment-3018 Jesse Reynolds Thu, 02 Oct 2008 17:52:29 +0000 http://www.scienceprogress.org/2008/09/start-me-up/#comment-3018 While it is true that "Geron... has been saying for years that it will soon start what would be the first human studies of an embryonic stem cell therapy," it's my understanding that Geron has not been ready to submit an investigational new drug application. The FDA didn't chime in - at least publicly - until the public forum on clinical trials in April. http://blogs.nature.com/reports/theniche/2008/04/gearing_for_nittygritty_questi.html While it is true that “Geron… has been saying for years that it will soon start what would be the first human studies of an embryonic stem cell therapy,” it’s my understanding that Geron has not been ready to submit an investigational new drug application. The FDA didn’t chime in – at least publicly – until the public forum on clinical trials in April.
http://blogs.nature.com/reports/theniche/2008/04/gearing_for_nittygritty_questi.html

]]> By: Tom Nichols http://scienceprogress.org/2008/09/start-me-up/comment-page-1/#comment-3010 Tom Nichols Wed, 01 Oct 2008 19:40:17 +0000 http://www.scienceprogress.org/2008/09/start-me-up/#comment-3010 It is amazing the way stem cell research has been politicised since 2001, this valuable research could have already shown itself and its potential to save and alter MILLIONS of lives for the better. At the time restrictions were placed upon stem cell research, researchers were speculating that diseases such as type one diabetes (which kills almost 2000 Americans a day) would be cured within ten years. It is amazing the way stem cell research has been politicised since 2001, this valuable research could have already shown itself and its potential to save and alter MILLIONS of lives for the better. At the time restrictions were placed upon stem cell research, researchers were speculating that diseases such as type one diabetes (which kills almost 2000 Americans a day) would be cured within ten years.

]]> By: rick weiss http://scienceprogress.org/2008/09/start-me-up/comment-page-1/#comment-3009 rick weiss Wed, 01 Oct 2008 17:59:38 +0000 http://www.scienceprogress.org/2008/09/start-me-up/#comment-3009 Merrill, There was a lot of discussion, as you might imagine, about these overseas treatments, some of which don't even try to appear to be science- or data driven and others of which do purport to be "studies" but whose leaders have so far refused to make public the data they are supposedly collecting. In the end, there is little to go on but anecdotal reports, in some cases of modest improvements (and the occasional "miracle")but with no control group or even historical controls to understand the background rate of spontaneous recovery etc. To tell you the truth, I thought the speakers at the conference (there was a whole session dedicated to overseas stem cell treatments, with an overflow crowd, including several very attentive people in wheelchairs)were not harsh enough in their assessment of these endeavors, or firm enough about the importance of entering this new field in an ethically and scientifically organized way. Rick Merrill,
There was a lot of discussion, as you might imagine, about these overseas treatments, some of which don’t even try to appear to be science- or data driven and others of which do purport to be “studies” but whose leaders have so far refused to make public the data they are supposedly collecting. In the end, there is little to go on but anecdotal reports, in some cases of modest improvements (and the occasional “miracle”)but with no control group or even historical controls to understand the background rate of spontaneous recovery etc. To tell you the truth, I thought the speakers at the conference (there was a whole session dedicated to overseas stem cell treatments, with an overflow crowd, including several very attentive people in wheelchairs)were not harsh enough in their assessment of these endeavors, or firm enough about the importance of entering this new field in an ethically and scientifically organized way.
Rick

]]> By: Merrill Goozner http://scienceprogress.org/2008/09/start-me-up/comment-page-1/#comment-3008 Merrill Goozner Wed, 01 Oct 2008 17:51:25 +0000 http://www.scienceprogress.org/2008/09/start-me-up/#comment-3008 Rick, Did those patients traveling abroad for unregulated treatments realize they could do far more to advance the field by insisting that their foreign hosts enroll them in clinical trials? Did the people in wheelchairs clamoring for access to therapies understand the importance of capturing all the data from experimental use under controlled scientific protocols? I hope the proponents -- especially the academic scientists and companies working on stem cell technologies -- understand the need to maintain regulatory standards as this technology proceeds. It's not just about patient safety, although that's important. It's ultimately about clinicians have a good understanding of what works and what does not, and not letting either the emotional demands of patients or the short-term and proprietary concerns of start-up biotech firms like Geron muddy the waters of that scientific understanding. Rick,
Did those patients traveling abroad for unregulated treatments realize they could do far more to advance the field by insisting that their foreign hosts enroll them in clinical trials? Did the people in wheelchairs clamoring for access to therapies understand the importance of capturing all the data from experimental use under controlled scientific protocols? I hope the proponents — especially the academic scientists and companies working on stem cell technologies — understand the need to maintain regulatory standards as this technology proceeds. It’s not just about patient safety, although that’s important. It’s ultimately about clinicians have a good understanding of what works and what does not, and not letting either the emotional demands of patients or the short-term and proprietary concerns of start-up biotech firms like Geron muddy the waters of that scientific understanding.

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