RE: Reporting Modeling Results

Steve, As usual, beating things to death. I certainly agree that post-marketing optimization is very useful. However, I said post-marketing (and intended to say outside the regulatory process) pk/pd. Great examples abound for post-marketing research, much of it in academics (the CAST study, recent work on Avandia - with apologies to former collegues at GSK, so much work on Coumadin in a-fib, once daily aminoglycosides, ACE inhibitors in heart failure, the list is very long). WRT studies such as special population (obese, elderly, young, renal failure), I'm interested in how many of these were done by ! academics, in their relentless search for truth, and how many were done by industry for regulatory or marketing reasons, and how many demonstrated clinical benefits, as opposed to just a pk difference. Mark Mark Sale MD Next Level Solutions, LLC www.NextLevelSolns.com 919-846-9185 > -------- Original Message -------- Subject: RE: [NMusers] Reporting Modeling Results From: "Stephen Duffull" <[EMAIL PROTECTED]> Date: Thu, October 25, 2007 6:52 pm To: "'Mark Sale - Next Level Solutions'" <[EMAIL PROTECTED]> Cc: "'nmusers'" < > > [email protected] > > > Mark, Nick I think there are two issues here. First, > I would, of course, have to disagree that regulatory and > marketing are minor shadows in the big picture - that is how > new medicine come to improve health. I would suggest that > better use of existing medicine is not much more than a minor > shadow, I think we may have to agree to disagree here. There is mounting evidence in a variety of therapeutic areas that post-marketing optimization of existing drug treatments by skilled clinical staff can improve patient outcomes. Indeed, there is growing research that indicates that the numbered needed to treat (NNT) may be in the order of 10-15 patients (i.e. treat 10 patients with optimized care on existing drugs to save 1 additional event). This value of NNT is about as good as any new drug is usually able to claim (treating AFib with warfarin has an NNT of about 100). So - I think the pre-marketing and regulatory aspects are as important as the post-marketing clinical aspects. Clearly we need new drugs - but we also need to use them better. And I don't think we can hope to learn everything there is to know about a drug during the drug development process. Second, > and while I think you're almost certainly right (as > usual), I can think of only a couple of examples where this > has been empirically shown that pk/pd informed dosing insight > GENERATED AFTER APPROVAL is better. There are also a growing number of examples where dosing that has arisen out of PKPD studies, that were gained after marketing, has provided significant patient benefits. We have seen this in patients who are obese (and often not included in pre-marketing trials) and with a variety of disease pathologies. It is (for me) without question that industry, regulatory and academia all play equally important roles in improving patient care. Regards Steve -- Professor Stephen Duffull Chair of Clinical Pharmacy School of Pharmacy University of Otago PO Box 913 Dunedin New Zealand E: > > stephen.duffull @otago.ac.nz > > P: +64 3 479 5044 F: +64 3 479 7034 Design software: > > www.winpopt.com