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Peter A. Balousek, MD Ryder P. Gwinn, MD Stephen C. Houston, MD Steve L. Klein, MD Daniel A. Lazar, MD Marc R. Mayberg, MD David W. Newell, MD James E. Raisis, MD Jayashree Srinivasan, MD Timothy D. Steege, MD Jacob N. Young, MD Ronald F. Young, MD, FACS Medical Director radiatioN oNcologists Daniel M. Landis, MD, PhD Robert M. Meier, MD Sandra S. Vermeulen, MD radiatioN oNcology Physicist Francisco Li, MS. As intensity of activation related to the control in the absence of TUDC, the presence of wortmannin caused a significant decrease in the TUDC-induced activation of Ras, from 8n2p3n5-fold to 2n3p1n3-fold n l 5 ; . The activation of the MAP kinases declined for Erk-1 from 3n6p1n1-fold in the absence of wortmannin to 1n2p0n2-fold n l 3 ; in its presence, and for Erk-2 from 8n2p1n2to 2n0p1n6-fold n l 3 ; . even more complete inhibition of TUDC-induced Ras, Erk-1 and Erk-2 activation was observed in the presence of LY294002 50 mol\l, n l 5 ; Figure 2B, Table 1 ; . These findings indicate that PI 3-kinase is involved in TUDCinduced activation of Ras and MAP kinase. In order to substantiate the involvement of PI 3-kinase in TUDC signalling, the activity of PI 3-kinase was assayed directly. Exposure of rat hepatocytes to TUDC 500 mol\l ; resulted in an approx. 2n8p0n9-fold n l 3 ; activation of PI 3-kinase within 5 min. TUDC-induced PI 3-kinase activation thus preceded TUDC-induced Erk activation compare Figures 2B and 3 and imipramine, because imdur dosage. Sections 9.4, 9.5, 9.5.1, Having previously discussed whether the materials were promotional material or non compliant patient education, members agreed that as Schering had argued that the intent was educational the Appeals Committee considered that the materials did not comply with the requirements for educational materials and therefore did not uphold the Schering Appeal in relation to Sections 9.4, 9.5, 9.5.1, The Committee did not accept Schering's argument that the materials were not broadcast to the general public. The definition of `general public' doesn't mean all members of the public have to be exposed to the material. Also, even if the sub-group of patients is well-informed, a company may not promote a particular medicine to them. As set out in the minutes of the Code of Conduct Committee meeting members concurred that the information brochure and DVD "Moving the treatment goalposts" were: promoting a prescription medicine to the general public promoting a non-approved indication not balanced and non-compliant as patient educational material due to the focus on a single treatment and were promotional Members also noted that the materials may: cause unnecessary alarm or misunderstanding in the community as the indication was not approved in Australia, not available on the PBS and therefore costly to a patient. The material may raise expectations beyond what is deliverable in terms of treatment outcomes and availability of the medicine. also cause alarm to a newly diagnosed patient who may expect immediate access to the new treatment but may have to wait up to 6 months to see a neurologist Section 9.8 The Committee did not uphold the Schering appeal in relation to the breach of `bringing the industry into disrepute' as the Therapeutic Goods Act and the Code clearly state that prescription medicines must not be promoted to the general public. In addition non-approved indications must not be promoted to healthcare professionals or members of the general public. The provision of promotional material to members of the general public is seen as an activity that would bring discredit upon the industry or reduce confidence in the industry and is treated as a severe breach. The danish medical birth registry the mbr, which comprises of data collected by midwives and doctors attending deliveries, contains information on all births in denmark since 1 january 1973 and tofranil.

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