tag:blogger.com,1999:blog-4241416962008169508.post6972850218645386823..comments2024-03-27T21:03:58.972-04:00Comments on Just A Life Sciences Blog...: Live-Blogging Any "Highlights" of Schering-Plough's West-Coast JP Morgan Web-Cast Presentation on Monday. . . .Unknownnoreply@blogger.comBlogger2125tag:blogger.com,1999:blog-4241416962008169508.post-73705493987196423912009-01-12T22:38:00.000-05:002009-01-12T22:38:00.000-05:00The draft guidance may be found at:http://www.fda....The draft guidance may be found at:<BR/><BR/>http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html<BR/><BR/>Now it does allow reviews etc. and on face everything appears OK, but seriously who really trusts companies to market drugs ethically and follow the rules anymore.<BR/><BR/>What could FDA have been smoking when they let this one through. The only thing I can think of is greenbacks.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-59886421209451233662009-01-12T22:12:00.000-05:002009-01-12T22:12:00.000-05:00So SP is working on it with FDA.Well today FDA rel...So SP is working on it with FDA.<BR/><BR/>Well today FDA released guidances that allows off-label promotion of drugs. As I recall this would allow even 'expert' opinions to be used as promotion. For example as based on memory this would allow position papers that antipsychotics should be used in children with ADHD to prevent the development of mania later in life or something to that effect. Even if evidence from other studies such as publications by Harvard's Biederman indicate that it would only be effective in hypermania.<BR/><BR/>Now it's common practice in the pharmaceutical industry to intentionally study drugs in such a way so as allow intentional overdosing in children. So if FDA officials were clearly trying to help get at least one particular drug by the reviewer by asking the reviewer to assess he inadequate pediatric studies on the last day of a review cycle while the reviewer was trying to meet deadlines and thus make a mistake and not catch problems and had also been trying to prevent the reviewer from discovering severe lethal toxicities that would result in numerous deaths especially with chronic use and overdosing. Then the reviewer might conclude that this would constitute a design to commit numerous assaults on children without any expectation of benefit and thus might meet the criteria of 18 USC 1111. And even if deaths had not yet occurred might still be a violation of 18 USC 1113.<BR/><BR/>Under such conditions the reviewer might feel compelled to contact Congress and the FBI and even to engage in other protected first amendment activities.Anonymousnoreply@blogger.com