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There were two important presentations, one involving trastuzumab, or Herceptin, and the second one involving a completely new drug for breast cancer called lapatinib, which is similar to Herceptin, and I'll get into that here really quickly in a second. The first study looked at the use of Herceptin for women who have not had any therapy for their breast cancer. I think it's important for people to realize this study, because it really speaks to the power of the use of trastuzumab. It's important to point out that trastuzumab is only efficacious or used in women whose cancers over expressed the HER-2 protein, and that's about one out of five women with breast cancer. The MD Anderson presentation at ASCO looked at women who had received chemotherapy by itself or chemotherapy plus Herceptin. The results of this study were fairly important. This study was actually stopped early because trastuzumab, in effect, tripled the response rate to chemotherapy in half of the patients that had received trastuzumab. I think that this was really a standard of care or a practice changing trial, because what it really showed us was that trastuzumab, for the patients who have HER-2 over expressing breast cancer, really in effect can triple the response rate to chemotherapy, and ultimately I think that that will save lives if trastuzumab was added to chemotherapy. So this was an important trial. Then to finish up, I myself presented data on a completely new way of treating breast cancer. Trastuzumab is an antibody and it binds to the HER-2 protein. Lapatinib is a new drug. It is a pill, so unlike the trastuzumab, which many of the audience might be familiar with, which is given through the vein or as an medication, this is actually a pill with little to no toxicity. There's no hair loss. There's no nausea. About five percent of patients will get diarrhea with this medicine. Unlike trastuzumab the way this drug works is it's almost like a direct bomb to the HER-2 and the EGFR receptor. So unlike trastuzumab, which only targets the HER-2 protein, this drug actually targets not only HER-2, but another important protein found in breast cancer, which is EGFR. Many of you might be familiar with this protein because it's the target for a drug called Iressa, which was recently approved in lung cancer. The study that I presented was in patients who had already received trastuzumab and their tumors and topiramate.

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The number of New Molecular Entities and biologics reaching the market in 2002 continued the trend of previous years, in that there were fewer of them. Marketletter's analysis of new product launches has revealed a continuing decline in the number of new active substances since a peak in the early 1990s, a trend which has been held up as evidence of a failure of R&D productivity throughout the pharmaceutical industry and a more stringent regulatory oversight of the sector. There was a fairly respectable tally of 29 NMEs and biologics introduced in calendar 2002, just two fewer than the haul in 2001 Marketletter January 21, 2002 ; and not too far away from earlier years. However, there is little doubt that the aforementioned factors are having an effect, given that many of the drug majors were promising to deliver three to five NMEs and or biologics a year in the late 1990s. As an example of the effects of regulatory factors, it is notable that Eli Lilly, with just one product launch last year for the benign prostatic hypertrophy drug Avodart dutasteride ; , could easily have added the attention-deficit hyperactivity disorder therapy Strattera atomoxetine HCl ; , Cialis tadalafil ; for erectile dysfunction and the osteoporosis drug Forteo teriparatide ; to its 2002 list had it not suffered manufacturing compliance problems. In contrast to 2001, when there was a preponderance of new products from biotechnology companies, the pharmaceutical majors flew the flag in 2002. Merck & Co and Pharmacia both put in a good showing with three introductions apiece, with AstraZeneca and Pfizer both managing two. This also illustrates the potency of the proposed Pharmacia Pfizer merger, as the combined entity will have five NMEs that are fresh to the market and in the growth phase when it comes to fruition. Turning to the products themselves, there seems to have been something of a decline in the roll-out of truly novel, first-in-class drugs in 2002, although this could change in 2003 when a slew of new biologics, and particularly antibody-based therapies, are set to reach the market for rheumatoid arthritis, psoriasis, cancer and asthma. Notable exceptions to this include Pharmacia's Inspra eplerenone ; , the first selective aldosterone antagonist for the treatment of high blood pressure to reach the market. Inspra lacks the progestational and anti-androgenic side effects of older, less selective aldosterone blockers, such as spironolactone, and has been tipped for blockbuster status if eventually approved for both hypertension and congestive heart failure. Schering-Plough and Merck & Co are hoping for great things from Zetia ezetimibe ; , a cholesterol absorption. Antimalarial drugs are divided i nto 4 classifications corresponding to their action on the different plasmodium life cycle stages in human host s see Table 5-1 ; . The 4 classes are listed below: 1 ; 2 ; 3 ; Blood schizonticides attack plasmodia in red blood cells preventing or terminating the clinical attack. Tissue schizonticides attack the exoerythrocytic forms in the liver Gametocytocidal drugs attack the gametocyte stage in red blood cells. Hypnozoiticidal drugs kill dormant P. vivax or P. ovale hypnozoites in liver cells.
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This is the third in a series of bulletins focusing on advances in therapy for HIV AIDS, particularly developments in triple therapy employing protease inhibitors. This bulletin looks at drug interaction in HIV therapy and provides an at-a-glance guide to known clinically significant interactions. There is also the second part of our website review for those working in the HIV AIDS field. Watch out for further update bulletins in the coming months, for example, ttadalafil information. Pharmacies, as opposed to the current practice, whereby one pharmacy serves the entire facility. III. Conclusion The MMA is landmark legislation, and as beneficiaries and providers begin utilizing and working with the benefit beginning in 2006, it will be easier to determine whether there is a need for further legislative or regulatory modifications. For now, CMS, within seven months, drafted proposed regulations, reviewed thousands of comments, and drafted final regulations implementing the most significant expansion of the Medicare program since its inception in 1965. In drafting those regulations, CMS had to grapple with a host of legal issues. This article describes four of them and CMS's final approach to the problem. Again, there will doubtless be need for modifications to the program as time goes by, but for the time being, the CMS regulations are a significant contribution to the implementation of the Part D benefit and tagamet.
What is the mandate of the Council of Europe in health policy and medication safety? The Council of Europe stands for a health policy, which is based on the principles enshrined in the European Human Rights Convention, in force since 1953 and the European Social Charter of 1961, the revised Social Charter of 1996, the Convention of Human rights and Bioethics 1997. The above-mentioned international treaties are achievements reached by the Council of Europe member states assuring respect and juridical protection of the individual human rights by national authorities and urging the entitlement to health services and social protection European Social Charter ; . In other words the health activities are aimed invariably at the democratisation and humanisation of health services for all 800 million European citizens in 45 member states. These elementary pillars of human cohesion are best characterised by the motto: "Health is a fundamental human right indispensable for the exercise of other human rights" Ausschuss fuer wirtschaftliche, soziale und kulturelle Rechte, General Comments , No 14 11 August 2000; christina.hausamman kwb be.ch ; . Consequentially a healthy population is the basic element for the economic welfare and political stability of a community. The Council of Europe's health agenda is executed by two steering bodies, which are in charge of facilitating the development of effective policies and strategies against health challenges regarding topical issues while at the same time pursuing longterm efforts: The European Health Committee encourages closer European co-operation amongst all 44 member states on the promotion of health under various aspects health policy, ethical and quality standards in the field of blood transfusion and organ transplantation, preventive measures, education for health and staff training. The Partial Agreement Public Health Committee aims at raising the level of health protection of the consumer in its widest sense in these Council of Europe member states which have concluded the Partial Agreement in the social and public health field. As outlined in the term the conclusion of a partial agreement is a well-used option in the sense of a "variable geometry co-operation", if a certain number of member states wish to engage in a specific field of interest common to all member states. May I refer you to the renowned examples of the European Pharmacopoeia Convention, the European Development Bank, and the Pompidou Group amongst others ; ? Whereas the cornerstones of the approach towards health protection and promotion remain unchanged, the working methods have certainly changed over the years: from European agreements to individual measures in the field of technical co-operation, significant questions related to health planning, education, prevention training of staff and questions having ethical implications. The legal structure of a partial agreement enables even flexibility, pragmatism and directness of the applied working methods and strategies. All aforementioned tasks and topics are studied by dedicated Committees of experts, delegated by the member states. The current Committee of experts on pharmaceutical questions, which has taken on the issue of medication safety, operates under the following terms of reference "Harmonisation of provisions concerning areas in the field of drugs, with a view to protecting public health". These terms of reference are deliberately set very wide in order to cover all aspects of pharmaceutical practice. The Partial Agreement rules, in alliance with the wide terms of reference, provide for rapid action in case of public health needs. The integrative approach and claim towards these problems is reflected in the conference programme as well as the choice of speakers and participants. The coherence of these targets with the agenda items of the conference programme should now become obvious. I have tried to give you a brief introduction to the principles and working structures of the Council of Europe with a focus on health policies, I will now deal with.

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