From owner-btk-mca@hgmp.mrc.ac.uk Wed Jan 16 05:01:04 2002 Return-Path: Received: from localhost (localhost [127.0.0.1]) by mercury.hgmp.mrc.ac.uk (Postfix) with ESMTP id C0CFF17B7A for ; Wed, 16 Jan 2002 05:01:02 +0000 (GMT) Received: from localhost (localhost [127.0.0.1]) by mercury.hgmp.mrc.ac.uk (Postfix) with ESMTP id 06C6417B79 for ; Wed, 16 Jan 2002 05:00:58 +0000 (GMT) Received: from niobium.hgmp.mrc.ac.uk (niobium [193.62.192.41]) by mercury.hgmp.mrc.ac.uk (Postfix) with ESMTP id 2FBFE17B73 for ; Wed, 16 Jan 2002 05:00:57 +0000 (GMT) Received: (from news@localhost) by niobium.hgmp.mrc.ac.uk (8.9.3+Sun/8.8.8) id EAA01690 for btk-mca-list@hgmp.mrc.ac.uk; Wed, 16 Jan 2002 04:54:30 GMT X-Authentication-Warning: niobium.hgmp.mrc.ac.uk: news set sender to using -f From: gdpusch@NO.xnet.SPAM.com (Gordon D. Pusch) X-Newsgroups: bionet.metabolic-reg Subject: Re: Realism in drug discovery Date: 15 Jan 2002 22:52:52 -0600 Organization: XNet Information Systems (Winstar) Lines: 34 Message-ID: References: <5.1.0.14.0.20020115235050.01b349b0@csmail.brookes.ac.uk> X-Complaints-To: abuse@xnet.com X-Newsreader: Gnus v5.7/Emacs 20.7 To: btk-mca@hgmp.mrc.ac.uk Sender: owner-btk-mca@hgmp.mrc.ac.uk Precedence: bulk dfell@brookes.ac.uk (David Fell) writes: > [...] What is very impressive, on the other hand, is the rise in research > costs per drug developed. Not when you consider some of the _EXTRINSIC_ factors driving it: 1.) The enormous number of hoops various gov't regulatory agencies (particularly the US's FDA) require drug developers to jump through before a new drug is even brought to clinical trials. 2.) The legal liability issues faced by a drug company, if the drug has ANY negative side effect of almost any type at all. 3.) The need in today's ``intellectual property'' regime to find a drug that is not merely safe and effective, but _PATENTABLE_. 4.) The need (at least in the US) to demonstrate that the drug is not merely safe and effective, but _MORE EFFECTIVE THAN ANY OTHER DRUG ALREADY APPROVED TO TREAT A GIVEN CONDITION_, before the drug will even be _considered_ by the FDA for approval to treat that condition. So it is hardly a surprise to me that drug development costs in the US average US$ 250 million per drug and climbing. For each drug that reaches the market, dozens of other potential drugs get dumped, not because they are no good, but because they are no better than existing drugs, or are not patentable. And when risk -- even INFORMED risk! -- is not an option, then success becomes =VERY= expensive... -- Gordon D. Pusch perl -e '$_ = "gdpusch\@NO.xnet.SPAM.com\n"; s/NO\.//; s/SPAM\.//; print;' .