tag:blogger.com,1999:blog-1474751880645498536.post6468332334230947762..comments2023-10-10T10:14:36.340-04:00Comments on Medical Evidence Blog: Falling to Pieces: Hemolysis of the Hemoglobin HypothesisScott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-1474751880645498536.post-771802446389207142015-09-30T14:38:27.545-04:002015-09-30T14:38:27.545-04:00Larger trials are usually more definitive Larger trials are usually more definitive Diuretic for dogshttp://naturaldiureticfordogs.blogspot.com/2015/08/natural-diuretic-for-dogs-with.htmlnoreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-79840372888355343382013-03-24T13:52:13.393-04:002013-03-24T13:52:13.393-04:00Ed, I think you're being facetious but I like ...Ed, I think you're being facetious but I like your points, especially on the FDA and ADs. In fact, a post on that nonsense is in the works. Thanks for your interest. ScottScott K. Aberegg, M.D., M.P.H.https://www.blogger.com/profile/17564774546019869201noreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-76751337958973216372013-03-14T02:25:23.611-04:002013-03-14T02:25:23.611-04:00Here you go: http://www.regulations.gov/#!document...Here you go: http://www.regulations.gov/#!documentDetail;D=FDA-2013-D-0077-0001<br /><br />"Draft Guidance for Industry on Alzheimer’s Disease"<br /><br />"The purpose of this guidance is to ASSIST SPONSORS . . ." by lowering the standards for approving drugs to treat AD.<br /><br />No pretense here that the FDA is going to protect the public from high-priced, ineffective drugs.<br /><br />They are stepping right up and "assisting sponsors."<br /><br />You might think that the FDA feels their mission is to protect drug manufacturers from the public, not the other way around.<br />Edward Murrayhttps://www.blogger.com/profile/06688920261195088879noreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-48930335981517623942013-03-13T23:49:51.669-04:002013-03-13T23:49:51.669-04:00Right Doc, lecture us about Forests and Trees whil...Right Doc, lecture us about Forests and Trees while you ignore the big picture.<br /><br />Just love it when you Evidence Based Med types decide that it is okay to only worry about clinical outcomes as if patients were the only stakeholder in this game.<br /><br />What about investors? What about the politicians with manufacturers in their district? Do you even know what the word J-O-B-S means? I won't ask if you care about the fate of all those C-suite types who have approved continued study of this drug for this new, blockbuster indication. Your narrow focus makes that seem highly unlikely.<br /><br />You toss around NEJM as if we are supposed to cower at its authority. Ever heard of WSJ, or Bloomsberg's?<br /><br />If we are going to have evidence based medicine, wouldn't it make sense to present all the evidence?<br /><br />In fact the statisticians in Marketing already see several silver lined clouds. When you do real analysis of the trial data, you can always find a subgroup for which a drug is important, maybe even vital. After all, there is a clear record that you just need approval for anything, Sales can take care of ensuring that ALL patients who could benefit get the drug.<br /><br />Regulatory Affairs is already talking to the FDA about developing more realistic trial end points based on some ideas they've gotten from the psychiatric pharmaceutical industry. Is mortality really more important than Happiness as measured by a psychiatric assessment instrument from Berkeley?<br /><br />And speaking of clinically irrelevant, manufacturers of drugs for "auto-immune" diseases such as MS have this down to a science. You can get the FDA to accept sensitivity to the smell of blue cheese from the moon as being relevant to an MS Disease Modifying Drug and as long as you are careful to cut the trial off at 27 months before elevated liver enzymes become frank hepatic failure.<br /><br />Fortunately, the grassroots United Patients for YOUng eRythrocytes Society (UP YOURS) group (1600 K Street, Wash DC) is now lobbying the FDA to get the agency to think more broadly, an effort that is fully supported by the Southern California Congressional delegation I should note.<br /><br />There is ample precedent for approval of drugs that fail clinical trials as long as you can get three positive ones. Might not be your kind of medicine Doc, but that's the law and this is a democracy, like it or not. This is clearly why manufacturers are continuing trials of drugs to clear a-beta in patients with AD in spite of the repeated failures. Three's the number. The FDA is not allowed to consider failed trials when you have three positive ones.<br /><br />Finally, all this negativity is depressing. At some point, even if these drugs repeatedly fail to show benefit in humans, you can pull a "tepoxalin" and sell it to dog owners since Muffy is unlikely to complain about the little hole you just blew in his tummy and the FDA will approve any veterinary drug application, worst case requiring some post-approval studies which are then never done. Just think of all the dogs with CHF to say nothing of the CKD kitties already being treated.<br /><br />Patients may get sent to the cemetery, but there is no burial place for failed drugs or indications. Once a certain amount of money and prestige are sunk into a drug for a particular indication, it will eventually be approved.<br /><br />Get with the program. There's a speaker's bureau being organized at this very minute and Marketing is looking for "authors" for a bunch of very positive and uplifting papers that their team of professional writers have crafted.<br /><br />You obviously aren't getting enough sun. I hear there's a CME-approved conference in Cancun on Advances in Cardiology and Hematology coming up soon. A few days of ocean air and golf will change your depressingly narrow view of the world.<br /><br /><br /><br /><br /><br /><br />Edward Murrayhttps://www.blogger.com/profile/06688920261195088879noreply@blogger.com