tag:blogger.com,1999:blog-5841910768079015534.post8836077234969992064..comments2024-03-29T08:40:11.883+00:00Comments on BishopBlog: The weird world of US ethics regulationdeevybeehttp://www.blogger.com/profile/15118040887173718391noreply@blogger.comBlogger10125tag:blogger.com,1999:blog-5841910768079015534.post-32601487062573135512011-11-30T09:02:41.291+00:002011-11-30T09:02:41.291+00:00So I guess the inclusion for the study specify ...So I guess the inclusion for the study specify 'ability to pay $$$$' . Interesting take on possible selection bias. A really nice teaching example, but what an awful reflection on this Institutions ethics.StephenMhttps://www.blogger.com/profile/18153124982957006434noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-30055909654052396392011-11-29T21:22:44.063+00:002011-11-29T21:22:44.063+00:00It's kind of allowed, but kind of not really -...It's kind of allowed, but kind of not really - the .pdf explains it, and you do have to get a waiver and you can't profit. <br /><br />Where the whole Burzynski thing comes into play, and what I haven't seen mentioned in articles yet, is that while they claim to be running clinical trials, a quick looksee at clinicaltrials.gov indicates that the trials were registered in the late 90s, and anything that is listed as "open/still recruiting" hasn't been updated since (at latest) 2009. These are all moving on towards being listed as abandoned, and the vast majority of said "trials" have been terminated or are listed as incomplete.<br /><br />What this means is that chances are very good that this "clinic" is operating outside of what is allowable by the FDA - if there are even any valid clinical trials going on, which I strongly doubt. <br /><br />(I think those listings primarily exist to allow the "clinic" to say that they have clinical trials running - taking some time to read thru everything that's been canceled or abandoned or otherwise ignored suggests they were never enrolling as many people into the trials as they claim. And for better or worse, people can pay what they want for woo.)Kellyhttp://www.kellyhills.com/blognoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-6850690401966407592011-11-29T21:22:39.484+00:002011-11-29T21:22:39.484+00:00Thanks for this-- my reaction was similar (as some...Thanks for this-- my reaction was similar (as someone with a similarly professional interaction with research ethics committees). <br /><br />I'd note that the guidence linked to on the page you refer to (http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf) does lay down some restrictions on when one can charge for an Investigatory Medicinal Product. <br /><br />On a quick look, the rule appears to be that you can charge, but only to recover the cost of the drug and only where that is necessary for the trial to go ahead and the cost of the drug is extraordinary. You also have to show that the drug has potential to 'provide a<br />significant advantage over available<br />products in the diagnosis, treatment,<br />mitigation, or prevention of a disease or<br />condition'. <br /><br />Importantly, it seems that the trial Sponsor (i.e. the organisationt that takes overall responsibility for the trial) has to get FDA approval for charging. <br /><br />One presumes that the chap in question has got the necessary authorisation.JJ_slimnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-71392657446816281272011-11-27T20:28:13.281+00:002011-11-27T20:28:13.281+00:00I would hazard a guess that Burzynski may well hav...I would hazard a guess that Burzynski may well have it fixed so that there is no specific charge on any bill identified as "a cost for being enrolled in the trial' - it is more that all their patients are 'enrolled in a trial' as this is how they get around other restrictions put on how they operate. But it does sound like people pay dearly for everything (see e.g. <a href="http://www.burzynskiscam.com/" rel="nofollow">this account</a> from some very pro-altmed folks).<br /><br />The whole Burzynski clinic story is awful, really, and the IRB stuff deeply troubling. But apparently the ethical review system in the US has always been pretty lax if you are working outwith the university/university-affiliated hospital mainstream. When I worked at the NIH a dozen years ago in a gene transfer lab, one of the common topics of discussion was that the private industry trials of human gene transfer were very minimally regulated. In contrast, if you were funded by federal tax dollars (i.e. by the NIH) you had to have the full panoply of ethical, IRB and regulatory approvals.Dr Austhttp://draust.wordpress.comnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-126642240640385122011-11-25T19:19:28.872+00:002011-11-25T19:19:28.872+00:00On the other hand, I know of a UK researcher who s...On the other hand, I know of a UK researcher who studied drug addiction and who was for a long time not allowed to pay his addict volunteers money in case they spent it on drugs.<br /><br />But then the REC changed their mind, decided that was unfair discrimination against addicts, and said that he <i>had</i> to pay them money if he was paying the controls money.Neuroskeptichttps://www.blogger.com/profile/06647064768789308157noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-17200146985953392292011-11-25T19:18:25.979+00:002011-11-25T19:18:25.979+00:00I am hoping that this story will hit the mainstrea...I am hoping that this story will hit the mainstream media soon. It certainly ought to.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-19215471009954900432011-11-25T15:24:09.378+00:002011-11-25T15:24:09.378+00:00+1 to Adam Jacobs's comment about being spot o...+1 to Adam Jacobs's comment about being spot on. I find the whole "pay to take part in trials" notion to be deeply disturbing and dangerous.anarchic teapothttps://www.blogger.com/profile/15202342480527269614noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-77549419622888435982011-11-25T11:25:00.288+00:002011-11-25T11:25:00.288+00:00I don't know why Google insists on me being un...I don't know why Google insists on me being unknown? I tried my google account ...Stephan Lewandowskyhttp://www.shapingtomorrowsworld.orgnoreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-70614929600017022112011-11-25T11:23:02.564+00:002011-11-25T11:23:02.564+00:00Dorothy, that is a truly bizarre case. Thanks for ...Dorothy, that is a truly bizarre case. Thanks for highlighting that. SteveUnknownhttps://www.blogger.com/profile/01291845864748092259noreply@blogger.comtag:blogger.com,1999:blog-5841910768079015534.post-52725365193000497382011-11-25T09:31:36.337+00:002011-11-25T09:31:36.337+00:00I think you're spot on here, Dorothy. As a mem...I think you're spot on here, Dorothy. As a member of an ethics committee myself, I agree that the way in which Burzynski's studies are clearly taking advantage of vulnerable patients, when they should be respecting their rights, is thoroughly unethical. It does appear that there is something questionable about the way Burzynski's IRB has been operating, given the concerns expressed by the FDA. I would love to know what enforcement action they have taken, but I suspect that any action they may have taken was inadequate.<br /><br />I'm not sure why this isn't making more news in the mainstream media as a terrible scandal.Adam Jacobshttp://dianthus.co.uknoreply@blogger.com