RE: Reporting Modeling Results

> -----Original Message----- > From: James G Wright [mailto:[EMAIL PROTECTED] > Sent: Friday, 26 October 2007 10:22 p.m. > To: 'Stephen Duffull'; 'Mark Sale - Next Level Solutions' > Cc: 'nmusers' > Subject: RE: [NMusers] Reporting Modeling Results > > Hi Steve, > > I think it would be a good idea for you to cite the > randomized studies that back up your points in order to move > this discussion forward. > > When citing a number need to treat, we also need to consider > the actually cost of doing so. It's not that the staff in > hospitals around the world are not skilled, it's just that > they are already very busy. > I'm trying to imagine a world where every hospital has a > specialist department for individually optimizing drug dosing > for a wide variety of drugs. What staff and equipment would > it require? Are these staff available? Would we require new > procedures in the hospital to implement > all of the different drug protocols? What are the actual numerical > costs? > > I am not asking these question rhetorically, I just think > that this is a very complex economic (rather than scientific) > question and I would value additional insight. > > Best regards, James > > James G Wright PhD > Scientist > Wright Dose Ltd > Tel: 44 (0) 772 5636914 > www.wright-dose.com > > > -----Original Message----- > From: [EMAIL PROTECTED] > [mailto:[EMAIL PROTECTED] > On Behalf Of Stephen Duffull > Sent: 25 October 2007 23:53 > To: 'Mark Sale - Next Level Solutions' > Cc: 'nmusers' > Subject: RE: [NMusers] Reporting Modeling Results > > > 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: [EMAIL PROTECTED] > P: +64 3 479 5044 > F: +64 3 479 7034 > > Design software: www.winpopt.com > >