Some snippage for brevity, and longish quotes b/c I think you can't get to Medscape articles unless you're registered- (and this is a minimal reply b/c it's getting late, but there are lots of articles to scan).
> Dan Minette <[EMAIL PROTECTED]> wrote: > > From: "Deborah Harrell" <[EMAIL PROTECTED]> > > > Dan Minette wrote: > > > > > >From: "Deborah Harrell" > > > > > > You are not taking into account the > advances made by universities and publicly-funded > institutes. > > > > > > For-profit drug companies *are not* the > only or even primary sources of drug innovation. > > > > > So, if we looked, we'd see that most of the > > > > > drug patents are held by > > > > > governments and universities? Or are you > > talking about something different > > > > > when you speak of innovation. > > > > Correct: drug _development_ is without > question the purview of the pharmas ..<snip>..Drug > _discovery_ > > > > comes from multiple sources, sometimes quite > > > > accidentally <snip> > > >...<snippage>said that only about 5% of drugs are > > > developed from > > > non-traditional sources, such as herbs or the > > > example you gave. > > > Fundamental research has been and is being done > at universities and government facilities... <snip> > > Which is what I said *originally* - check that > first sentence above again. > I saw your first sentence, and it is inconsistant > with what I've been told > by people who work in the field. Development of a > drug only comes _after_ > it shows promise in animal tests. But _discovering_ that drug can be in the course of basic or esoteric research, or even seredipitously. Naturally-occuring chemical compounds were a large source of many 'new' drugs in past decades (think antibiotics esp.), and in oncology is still very important: http://www.medscape.com/viewarticle/433928 Anticancer Drug Development: A Global Perspective [Disclosures:'no significant financial disclosures' for the 3 authors listed] Michelle L. Washart, PharmD At the international symposium "Anticancer Drug Discovery and Development Throughout the World," held during the 38th Annual Meeting of the American Society of Clinical Oncology,[1] leaders from around the globe led thought-provoking discussions on issues of drug development. Identifying New Products: A Collaborative Effort The session opened with Dr. Gordon Cragg from the Developmental Therapeutics Program at the National Cancer Institute (NCI) providing a review of the NCI's Natural Product Repository Program. This program is becoming increasingly important in the treatment of cancer, as a number of important anticancer agents have been derived from natural products, including plant-derived agents (such as the vinca alkaloids, taxanes, and topoisomerase I inhibitors), microbe-derived agents (such as the anthracyclines, epothilones, and rapamycin analogues), and marine-derived agents (such as bryostatin and dolastatin 10). Dr. Cragg described the NCI's process for establishing collaborations with source countries to develop programs to screen potential anticancer agents. Currently, such collaborations exist with over 15 countries, including Australia, Brazil, China, Costa Rica, Fiji, New Zealand, and Pakistan. There are 2 methods by which this process occurs. A "Letter of Collection" agreement is used in arranging to allow collecting of materials from a foreign country for screening, evaluation, and testing. This agreement contains terms related to conservation, training, technology transfer, and the protection of rights of the source country. By contrast, a "Memorandum of Understanding" is used when the foreign country provides extracts and compounds directly to the NCI. In this agreement, NCI collaborates with a qualified source country organization (SCO): the SCO collects the materials and NCI assists in screening the compounds for anticancer or anti-HIV activity. By covering developmental costs, NCI also collaborates with the SCO in developing new agents that meet established criteria. This program is an excellent example of how global cooperation can succeed in the discovery and development of new anticancer agents. Re: government discovery and development: ...In 1998, the Cancer Therapeutics Research Group was formed as a collaboration between the University of Singapore and Australian groups. Since that time, Hong Kong and US sites have joined the group. There were 3 primary concepts behind the collaboration: (1) to provide a platform for drug development simultaneously in Asian and white populations; (2) to provide the pharmaceutical industry with an Asian-Pacific database for drug development; and (3) to study cancers that are common to Asians such as stomach cancer. Dr. Wong described 2 interesting trials initiated by this group. The first was a combination trial with docetaxel and carboplatin in non-small-cell lung cancer (NSCLC) that demonstrated a 65% response rate in Asian patients and only a 31% response rate in whites. This difference was evaluated and determined to be due to differences in the metabolism of docetaxel. Specifically, since Asians metabolize docetaxel much more slowly than do whites, they demonstrated an AUC that was almost double that of the white patients. The data from this trial are expected to be published shortly. The second study Dr. Wong described was presented at Saturday's poster session.[2] This study demonstrated interethnic differences in myelotoxicity with doxorubicin and cyclophosphamide in breast cancer patients. Of interest, a substantially higher portion of Singaporean patients (55%) experienced severe myelotoxicity vs Australian patients (20%). Dr. Wong ended his presentation by stating that the future of this field of research is in microarray technology and developing gene expression profiles -- a concept echoed in many talks throughout this conference. Offering the Japanese perspective, Dr. Nagahiro Saijo from the National Cancer Center Hospital in Japan described the current state of anticancer research in Japan. Over the past few years, research has greatly improved largely because of the creation of the Japanese Clinical Oncology Group (JCOG) by the government. Dr Saijo also discussed Japan's contribution to cancer drug development including the contribution in the development of irinotecan, ZD1839, tegafur, and other agents... >From a pharma: ...The final address of the session was delivered by Dr. David Parkinson, from Novartis Pharmaceuticals, who discussed global drug development from the perspective of a global pharmaceutical company. Dr. Parkinson noted that although the opportunities are enormous, there are significant challenges to global drug development. Some of the more major threats facing the pharmaceutical industry include the increase in the cost of research and development without an attendant improvement in productivity (ie, the number of agents approved) the longer development time without a corresponding decrease in development risk; and the increasingly conservative regulatory climate coupled with the increasingly difficult reimbursement setting. The current reality in industry-sponsored clinical trials is that the majority of registration trials are focused on the United States and Europe. The changing reality, however, is that as the number of new agents increases, there is an increased need for patients in clinical studies that cannot be met within the United States. Thus, the interest in drug development globally is increasing within the pharmaceutical industry, particularly because there is an increased capability of countries outside of the United States to perform these trials. Some of the factors to consider in the move to truly global trials are: How common is the disease in various parts of the world? Is there a uniformly accepted standard treatment? Are there likely to be differences in the magnitude of response or in the toxicities within certain populations? > That development takes years, IIRC 5 > years is a goal now for fast tracked drugs, but it > represents only a > fraction of what drug companies do in R&D. Unlike > most companies now, drug companies actually do R. > > They need to find the candidates in the first > place....few candidates are > handed to them by universities or are found by > happenstance. They have to > search for candidates. This search is done by trial > and error sometimes, > and it is now guided by computer programs that take > knowledge of chemical > reactions and models likely results of various > chemical combinations. It > is much more research than what I do, for example. > It is actual trailblazing research. The article I cited deals with cancer research/drugs only; I will look for others, frex antibiotics and antihypertensives, heart drugs etc. > Part of it is semantics, I guess. But, in the world > of R&D, development has a very specific meaning. > The first compensated neutron tool was a real > research project. By your > standards, since quantum mechanics is known, it's > just a development > project, but I think that doesn't acknowledge what > it takes to innovate. > Let me try one more example. By your standards, > only Maxwell could be > credited for finding E&M. Everything else (radio, > radar, TV, generators) was just development. That's a teeny bit of exaggeration... ;) I already acknowledgeded the pharmas near-undisputed in the drug development arena, and no-where did I call it "just" or "merely." But I will not call 'me-too' drugs that have no significant advantage over predecessors "significant discoveries" either. Debbi __________________________________ Yahoo! Mail - PC Magazine Editors' Choice 2005 http://mail.yahoo.com _______________________________________________ http://www.mccmedia.com/mailman/listinfo/brin-l
