tag:blogger.com,1999:blog-5251734313338196429.post5523632731056352184..comments2024-02-27T04:00:13.116-08:00Comments on Cell Therapy Blog: Does Cell Therapy Demand a Different Investigatory-to-Commercial Paradigm?Lee Bucklerhttp://www.blogger.com/profile/05830444908952419444noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-5251734313338196429.post-34555295923377156622009-01-10T17:31:00.000-08:002009-01-10T17:31:00.000-08:00I dont understand the concept of "medical tourism"...I dont understand the concept of "medical tourism", either something works or it doesnt and thats the bottom line. <BR/><BR/>The problem is that we get so caught up in thinking about political arguements (ie patients have a right to decide vs everyone offshore is a charlatan) that we forget the basic reasons why people do go offshore<BR/><BR/>take autologous therapy...autologous fat stem cells have been known for almost a decade to be useful in stimulation of angiogenesis...places such as www.cellmedicine.com do autologous adipose with some interesting data...they have evenpublished some of their other approaches...but this is an example of something based on good science...you cant compare autologosu adipose or autologous bone marrow "medical tourism", with crazy embryonic stem cell injections into peopleAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-5251734313338196429.post-89794293322849659272008-08-10T17:45:00.000-07:002008-08-10T17:45:00.000-07:00Lee,Another great post. Medical Tourism is a stra...Lee,<BR/><BR/>Another great post. Medical Tourism is a strange phenomenon, and I am still uncertain if I am for or against. Some of the questions you pose remind me of a few posts by Ogan Gurel at Life Science Chronicle. Ogan thinks Safety should be the main driving force behind FDA decisions; see (http://blog.aesisgroup.com/2007/07/02/fda-tortoise-hare-or-something-else.aspx) & (http://blog.aesisgroup.com/2007/07/06/fda-reform-redux-on-business-models-regulatory-reform-and-safety.aspx) and that the market should be left to decide efficacy. He argues that as long as therapies do no harm, then the ones that work will eventually win out. It is an interesting way to think of FDA reform, and would have some interesting impacts on cell therapy. Would love to hear your thoughts on these concepts..... JONAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-5251734313338196429.post-78887359056400725642008-08-07T16:28:00.000-07:002008-08-07T16:28:00.000-07:00This week's (4 Aug 2008) GEN podcast is on a relat...This week's (4 Aug 2008) GEN podcast is on a related topic: CLINICAL TRIAL ETHICS IN THE DEVELOPING WORLD<BR/><BR/>http://www.genengnews.com/gencasts.aspxLee Bucklerhttps://www.blogger.com/profile/05830444908952419444noreply@blogger.comtag:blogger.com,1999:blog-5251734313338196429.post-66499924294541869062008-08-07T10:15:00.000-07:002008-08-07T10:15:00.000-07:00It came to mind this morning that the Dendreon Pro...It came to mind this morning that the Dendreon Provenge case is another example of US patients showing increasing frustration with the FDA saving people from their own power of choice. The agency is worried at this point, as I understand it, about safety - only efficacy. I understand the need for a standard which new therapeutics must meet to be approved for sale but we're also denying patients access to a therapy that is relatively safe and the evidence to-date shows work well for some patients. In the instance of Provenge, these patients are not taking this lying down. There must be a model that better balances the interests in certain circumstances.<BR/><BR/>--LeeLee Bucklerhttps://www.blogger.com/profile/05830444908952419444noreply@blogger.com