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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (7080)	9/21/1999 10:15:00 PM
From: biowa	Read Replies (1) \| Respond to of 9719

Rick, Here is the report of the Advisory Panel meeting (2/98) as reported in Infectious Disease News (cached at Google), and trying to be fair here: <<The committee recommended that Synercid be approved for the following indications: complicated skin and skin-structure infections; infections due to vancomycin-resistant Enterococcus faecium (VREF); and nosocomial pneumonia. Synercid's efficacy in the treatment of complicated gram-positive skin and skin structure infections...yielded a statistically equivalent clinical response (approximately 71%) as cefazolin...and vancomycin. The overall tolerance, however, was better in the comparator group, particularly regarding venous adverse events. To evaluate the safety and efficacy of Synercid in the treatment of VREF, 401 patients were enrolled in a non-comparative phase 3 study and an emergency use study. The study population had an overall mortality rate of 52%. Synercid...was shown to have an overall success rate of 65.4% in the evaluable population. A total of 298 patients were enrolled in 111 centers to determine the efficacy and safety of Synercid in...the treatment of gram-positive nosocomial pneumonia. Synercid...plus aztreonam...was shown to have statistically equivalent success rates (approximately 46%) as vancomycin...plus aztreonam "It is difficult to say with absolute certainty that this drug is efficacious in VRE infections due to the lack of a comparator," said committee member David E. Soper, MD, professor of obstetrics/ gynecology and internal medicine, division of infectious diseases, at the Medical University of South Carolina in Charleston. "However, the risk/benefit is clearly in favor of approving this agent, now making it available to clinicians dealing with these serious infections." Editor's note: Don't expect any miracles from this drug. Although it is good to have it available, it will in no way resolve our VRE problems. - T. Eickhoff>> Note the FDA declined to give RPR nosocomial pneumonia I wonder if they gave them MRSA skin and soft tissue because RPR threatened to not market the drug if all they got was VRE. The two comments basically tell it like the FDA apparently saw it, "anything for VRE is better than nothing." One fact also missed in the CNN and PR coverage, unless I'm wrong, is that Synercid must be administered via a central arterial line. Bottom line: There is ample opportunity for much better gram positive antibiotics. biowa