tag:blogger.com,1999:blog-6782790349293784670.post8790596844654896238..comments2023-10-04T06:06:07.716-05:00Comments on <a href="http://www.placebocontrol.com">Placebo Control</a>: Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA?Unknownnoreply@blogger.comBlogger7125tag:blogger.com,1999:blog-6782790349293784670.post-51328111882062010422022-12-07T07:14:35.105-06:002022-12-07T07:14:35.105-06:00Like different bonuses, your welcome bonus must be...Like different bonuses, your welcome bonus must be wagered a certain number of times before you'll be able to|you presumably can} withdraw it. Not all games contribute equally to the rollover necessities. For instance, slots usually depend one hundred pc path of|in path of} assembly your wagering necessities, whereas table games like blackjack and roulette only contribute 10-20%. Wagering necessities are the conditions that you should meet so as to be able to|to have the ability to} withdraw your winnings from a casino bonus. These necessities usually contain betting {a certain <a href="https://vjtmxmzkwlsh.com/%EC%9A%B0%EB%A6%AC%EC%B9%B4%EC%A7%80%EB%85%B8/" rel="nofollow">우리카지노</a> amount|a particular amount|a certain quantity} of funds or enjoying in} through your bonus a certain number of times. No-deposit bonuses are much less widespread, however they're nice if you want to|if you want to} check out a casino without risking any of your own cash.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-15403793512591712102013-08-15T17:19:09.187-05:002013-08-15T17:19:09.187-05:00Hi Ed,
Thanks for the update. I'm going to tr...Hi Ed,<br /><br />Thanks for the update. I'm going to try one more time with the authors, and if that fails will produce and post an extract from ClinicalTrials.gov in order to (try to) replicate their methods.<br /><br />The conversations I've had in the past weeks with pharma clients have further solidified my opinion that there is a high rate of compliance with FDAAA reporting requirements. There seems to be no way to reconcile the issues apart from public review of the actual data.<br /><br />PaulPaul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-89467654410859373952013-08-13T10:55:36.961-05:002013-08-13T10:55:36.961-05:00Hi Paul,
In the interest of following up, I conta...Hi Paul,<br /><br />In the interest of following up, I contacted the NIH for clarification on the posting requirements cited in the study. The NIH reply appears in the form of my own comment here...<br /><br />http://www.pharmalive.com/fighting-cancer-may-be-harder-as-many-drug-trials-are-undisclosedhed#comment-110884<br /><br />Hope this helps,<br /><br />Ed Silverman<br />your usual suspect at Pharmaloted silvermannoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-51398079553950607642013-08-05T12:06:47.495-05:002013-08-05T12:06:47.495-05:00Andrew,
Thanks for your comments. I think you pro...Andrew,<br /><br />Thanks for your comments. I think you probably have a good point that more results can and should be posted. In fairness, I think this would require an expansion of FDAAA requirements: that's an issue worth more substantive discussion, and I will try to cover it in a post very soon.<br /><br />However, I do not think that this is "arguing the fine print". This is the 2nd study that is essentially claiming that companies are routinely breaking the law, and this claim is being picked up as a talking point for those who make a living attacking the research world (see multiple links, above). That's why I chose to review this study's methods, as we've had prior experience of an even weaker study being stripped of all qualifications and put forward as clear proof of pharma wrongdoing. <br />Paul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-58028298790528096212013-08-03T16:29:34.444-05:002013-08-03T16:29:34.444-05:00Paul you make a good case that the pharma companie...Paul you make a good case that the pharma companies are not "brazenly" ignoring the FDAAA requirements. But that is kind of arguing the fine print. The fact remains that overwhelmingly, clinical trials listed on ClinicalTrials.gov do NOT contain any results. Sure some trials are published in the literature eventually, but the average Joe or jane patient definitely does not feel like they have access to much of the clinical data that has been collected.BioDueDiligencehttp://www.biotechduediligence.comnoreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-28561713986258922662013-08-02T06:45:08.823-05:002013-08-02T06:45:08.823-05:00Thank you for your comments.
For the record, I si...Thank you for your comments.<br /><br />For the record, I signed the AllTrials petition back in early February - just before GSK announced their signing on. You could look it up: my name is not terribly common, and the list is not terribly long.<br /><br />Even so, I'm not sure why you're "surprised" that I "make no comment" on my support for general principles of transparency in this post. I was reviewing a much-publicized study that I felt contained, potentially, severe methodological flaws that might entirely compromise its findings. I did not pause to re-pledge my support for AllTrials, just as I would not expect my physician to preface a review of my medical tests with a solemn recitation of the Hippocratic Oath. <br /><br />It's patently false that these 2 academic studies of FDAAA compliance represent "the best currently available evidence". We have the announced results of the FDA's internal review. While those results were not published in the BMJ, they do have the benefit of being the only evidence based upon direct inspection of the actual data. The BMJ and JCO studies used unreliable proxy measures, producing (predictably enough) unreliable results. I would encourage you not to cite either of those papers with the same unequivocal certitude as you have recently.<br /><br />If you will indulge me, I have a question for you:<br /><br />At the end of my post, I call on the JCO authors to publicly post their data. It would seem to me that if their methods are sound, then their data would allow us all to clearly see which companies are out of FDAAA compliance. I couldn't help but notice that you ignored that part. Will you join me in urging the authors to make their entire dataset public?<br />Paul Ivsinhttps://www.blogger.com/profile/06181799073130665855noreply@blogger.comtag:blogger.com,1999:blog-6782790349293784670.post-50567651134631895712013-08-01T18:02:22.883-05:002013-08-01T18:02:22.883-05:00There is a clear need for routine and fully open p...There is a clear need for routine and fully open public audit on the compliance with all transparency legislation. One way to achieve this would be for the FDA to post all correspondence relating to applications for delay in results reporting onto ClinicalTrials.gov, immediately after it is received. It would also be appropriate for ClinicalTrials.gov to have a data field denoting whether a trial is required to be compliant with FDA AA 2007, since this is clearly a matter that is contested by individual trialists. I understand that industry has lobbied heavily against this measure. Meanwhile, we do at least have access to these audits published in the academic literature. They are the best currently available evidence. <br /><br />I am surprised that you make no comment on the key issue: doctors and patients need all the results of all the trials that have been conducted on a treatment, to make informed decisions about which is best. That's not an unreasonable request, and it is not currently met. This is a serious failing that undermines our best efforts to practice evidence based medicine, and it has been well-documented - with solutions proposed but never adequately implemented - for at least three decades. <br /><br />I hope you and your readers will join the many other ethical professionals in industry and sign up to the AllTrials campaign, calling for all trials to be registered and all results reported, at www.alltrials.net<br /><br /> Ben Goldacrehttp://www.badscience.netnoreply@blogger.com