tag:blogger.com,1999:blog-33960805.post4021613543058854717..comments2023-10-30T02:03:47.513-07:00Comments on Clinical Psychology and Psychiatry: A Closer Look: Defending the Hiding of Negative Clinical Trial DataCL Psychhttp://www.blogger.com/profile/13990549972520745769noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-33960805.post-47338061069849931552008-01-25T11:53:00.000-08:002008-01-25T11:53:00.000-08:00Hate to make a brazen promotional pitch, here, but...Hate to make a brazen promotional pitch, here, but the subject and emotion of this debate screams for it. (Not to mention that when the popular press hits this hypercritical button these days, it is so often about psychiatry.) <BR/><BR/>On May 31, 2007, I wrote to the CEOs of the 10 largest pharmaceutical companies (copying Andrew C. von Eschenbach, MD Director, Food and Drug Administration) informing them that ...<BR/><BR/>"... Psychopharmacology Bulletin, a peer-review, indexed journal about new developments in psychopharmacology, is introducing a stand-alone section called Negative and Failed Trial Reports. <BR/><BR/>"Our purpose in introducing a negative trials section is threefold: One, it is of vital importance to our readers. Two, the data is readily available from pharmaceutical manufacturers in the brain sciences, and, three, in the current atmosphere of public and governmental mistrust of industry, it is in everyone’s best interest to discuss clinical trials, which have not had a forum to be scrutinized.<BR/><BR/>"We are taking a top-to-bottom approach in writing to you as chief officer in the hope that we receive full cooperation from your scientific and marketing departments. Let me assure you of our determination to be fair and unbiased. For example, we will not allow articles published in the Negative Trial Outcomes section to be used by a competitor to adversely market one drug against another.<BR/><BR/>"A similar letter has been sent to the chief executives of every other pharmaceutical company which makes or markets psychotropic agents. We would very much appreciate your efforts to disseminate this information within your organization.<BR/><BR/>"Finally, we believe that Bulletin’s Negative Trial Outcomes will, ironically, reflect positively on the methodology used to bring drugs to market. We hope you concur."<BR/><BR/>Michael Thase, MD, our editor-in-chief, and David Sheehan, MD, MBA, the editor of the new section, and I received very positive initial responses from these companies -- but, as you may guess -- except for Ortho-McNeil and Pfizer, most everyone is still trying to round up the data. At the same time, Bulletin initiated an "Invited Commentary" section to run adjacent and give counterpoint to articles that could be perceived as biased. (The first such commentary was penned by Daniel J. Carlat, MD, a prominent spokesperson on industry conflict in his own right.)<BR/><BR/>The first two published Negative & Failed Trial Reports, as well as Carlat's Commentary, can be found at http://www.medworksmedia.com/psychopharmbulletin/<BR/>index_archives.php?id=22<BR/>(For anyone wishing full text articles, please email me at editorial@medworksmedia.com)<BR/><BR/>Any suggestions as to how we can secure the results of these "negative outcomes" would be much appreciated. Thank you.<BR/><BR/>James M. La Rossa Jr.<BR/>MedWorks Media Global<BR/>Los Angeles, CAAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-33960805.post-71698917485675342112008-01-23T05:37:00.000-08:002008-01-23T05:37:00.000-08:00Marilyn,1. Nathan claims he is a drug company scie...Marilyn,<BR/>1. Nathan claims he is a drug company scientist. If this is true, he may want to read up on how drug trials are written up.<BR/>2. No comment.<BR/><BR/>Bob,<BR/><BR/>I'm pressed for time right now, so I'll have to get to your points later. Suffice to say for now that you and I see things quite differently.CL Psychhttps://www.blogger.com/profile/13990549972520745769noreply@blogger.comtag:blogger.com,1999:blog-33960805.post-16042177084460911652008-01-22T18:07:00.000-08:002008-01-22T18:07:00.000-08:001. Who is Nathan and why should I care what he thi...1. Who is Nathan and why should I care what he thinks?<BR/><BR/>2. Why do you even bother reading Drug Wonks?Unknownhttps://www.blogger.com/profile/16193362190826548025noreply@blogger.comtag:blogger.com,1999:blog-33960805.post-81934703875577663222008-01-22T16:21:00.000-08:002008-01-22T16:21:00.000-08:00Where do I start? First, a concession. Lumping V...Where do I start? <BR/><BR/>First, a concession. Lumping Vioxx in with the other drugs was not something I would do in retrospect. Of course switching painkillers are not likely to lead to death. But that's a small point. On to your larger ones.<BR/><BR/>Most negative studies confirm hypotheses... Of course they do. That's the nature of research. Your statement that designing and conducting clinical trials to demonstrate efficacy of psychopharma drugs is "easy" reveals a lack of understanding of how to do them and run them. And if you want evidence, I have tons. I provided the Carol Tammigma editorial that came from the AJP edition that dealt with just that issue if you care to read it. <BR/><BR/>Second, I guess you are denying that fearmongers have not driven people away from taking SSRIs, Avandia, Vytorin, vaccines. Okay. I have evidence if you want. <BR/><BR/>Third, David Graham got a good spanking at the AdCommm over his Vioxx data which was not adjusted for severity of illness or prior use of other meds or previous cardiovascular incident, just the sort of things you would adjust for. Does this mean you would not be careful in the use of Vioxx. Of course not. But Graham is arguing FDA colludes with industry to keep unsafe drugs onthe market all the the time. He counts Crestor and Avandia as two of them. And SSRIs as the rest along with Accutane. Hmmm. <BR/><BR/>As for my slanderous attack on Poses. He calls me a tool and claims that doctors who consult for industry can't be trusted...what about those who have a political bias or consult for trial attorneys or advocacy groups that want to nationalize health care. Can they be trusted. His slant runs one way and then he sets himself as the high priest of health care purity and when I go on offense he takes offense. Too bad. <BR/><BR/>Again, you are right to point out my rhetorical overreach on Vioxx but address my larger points too. We may not wind up agreeing but at least we may wind up respecting each other...Bob GoldbergAnonymousnoreply@blogger.com