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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Slugger who wrote (8320)	1/16/1999 11:43:00 PM
From: aknahow	Read Replies (1) \| Respond to of 17367

No, that is not the case. If one goes back to the fact that this is a rare disease it would have taken years and years to get a sufficient number of accruals to become a statistically significant trial. During those years many kids would die. It was a sound decision on the part of all the FDA the DSMB and XOMA to arrive at a compromise method which would provide convincing data for the medical profession, scientist and officials at the FDA. It evidently became clear that the quickest way to get there was to allow the trial to be halted when ??X?? number of deaths occurred. But things changed as the U.K. was added. Yes this meant now it might have been possible to do a trial based on accrruals. Yes the U.K. resulted in more deaths in total quicker than expected. But then quicker diagnosis in the U.K. might have lowered deaths and then if BPI is effective even fewer might have occurred. So the U.K. is what is making it posssible to halt the trial sooner. And with 20/20 vision knowing how many the subjects the U>K. would add a different trial design might have been possible. But does one risk stopping the trial before the mandatory number of deaths have occurred, when the data is blinded to management? If you guess wrong, and stopping is not acceptable, then your drug never gets to the kids. In this situation of a rare disease I think everything was done by all to find the quickest way to end this trial. Disclaimer. All the above is based upon only one fact, "total deaths" Everything else is pure conjecture, none if may be true some of it may be false. I have no knowledge of how the trial was designed nor any knowledge of how the FDA made its' decisions on this trial. I still believe the FDA should only be in the business of determining safety, but at the time the trial was designed I think what I speculate was done was a great decision, and one that was designed to save lives.

To: Slugger who wrote (8320)	1/17/1999 1:22:00 AM
From: aknahow	Respond to of 17367

From the U.K.: Two teenagers die in outbreak of meningococcal disease in Rotherham Two teenagers, a 14 year old girl and a 15 year old boy, died of meningococcal disease on New Year's Eve. They lived about half a mile apart in neighbouring communities of Rotherham, in South Yorkshire, and attended different years of the same school. Both were infected with Neisseria meningitidis, identified as serogroup C on the basis of urinary antigen testing1 and confirmed, one by polymerase chain reaction and one by isolates from blood culture and nasal swab. Chemoprophylaxis and subsequently vaccination against serogroup C were given to close contacts of the two cases and to all children at the same school. A third teenager from the same area, a 16 year old girl, has since been admitted to hospital as a suspected case. She belongs to the same social network as the two teenagers that died and attended the same school until June 1998. Prophylaxis (antibiotics and vaccine) is being offered to an extended group of close social contacts who make up the wider circle of friends of the three linked cases. Local public health doctors have advised people to call an advice line if they have kissed on the mouth or had prolonged and close social contact (for example, at a private party or among friends at a pub) with any of the three cases. A further case of confirmed serogroup C disease and three cases of suspected meningitis in the same health district are not believed to be linked to the outbreak. 1. Al-Wali W, Hughes C. Urine antigen detection can be quicker than PCR in the diagnosis of meningococcal disease. J Hosp Infect 1998; 40: 326-8. Two teenagers die in outbreak of meningococcal disease in Rotherham 10 Salmonella infections: monthly report 10 13-16 Meningococcal disease in adolescence: an integrated social, biological, and psychological investigation A two year case control study designed to investigate risk factors for the development of meningococcal disease in teenagers aged 15 to 19 years starts this week, funded by the Meningitis Research Foundation, and supported by the Public Health Medicine Environmental Group. Previous studies that have addressed risk factors for disease have included very few teenagers, and a recent increase in the incidence of meningococcal disease in this age group in the United Kingdom has made a large study of adolescents vital. This study's results, which will be available in the summer of 2000, should inform health promotion strategy or targeted vaccination schemes. Meningococcal disease in adolescence: an integrated social, biological, and psychological investigation A two year case control study designed to investigate risk factors for the development of meningococcal disease in teenagers aged 15 to 19 years starts this week, funded by the Meningitis Research Foundation, and supported by the Public Health Medicine Environmental Group. Previous studies that have addressed risk factors for disease have included very few teenagers, and a recent increase in the incidence of meningococcal disease in this age group in the United Kingdom has made a large study of adolescents vital. This study's results, which will be available in the summer of 2000, should inform health promotion strategy or targeted vaccination schemes. continued on page 12 Influenza activity starts while Christmas interrupts surveillance Media interest in influenza over the Christmas period intensified in the New Year, as it did two years ago1, as large numbers of hospital consultations and admissions for respiratory infections were reported throughout England and Wales. Rates of patients consulting general practitioners for 'influenza and influenza-like illness' reported by the Royal College of General Practitioners sentinel surveillance scheme doubled from 94 per 100000 population in week 52/98 (ending 27 December 1998) to a provisional rate of 185/100000 in week 53/98 (ending 3 January 1998), remaining just below the threshold of 'increased seasonal activity' (>200 cases/100000) and some way below the epidemic threshold (>400 cases/100000)2. Age specific rates exceeding 200/100000 have been reported, however, in children under 4 years of age and adults aged 45 to 64 years continued on page 12 Communicable Disease Report Vol 9 No 2 8 Jan 1999 Meningococcal disease in adolescence: an integrated social, biological, and psychological investigation (continued from page 9) It is hoped that up to 200 cases will be recruited from six regions of England (Trent, Anglia and Oxford, North Thames, South Thames, South and West, and West Midlands) over the next 15 months. A control matched for age and sex will be sought from the list of each case's general practitioner. Subjects will be studied using questionnaires, blood specimens, and throat swabs. Consultants in communicable disease control are asked to inform the study's clinical research fellow, Dr Jo Tully, of cases of suspected meningococcal disease in teenagers between 15 and 19 years of age within 24 hours of their admission to hospital. Contact can be made between 0800 and 2300 seven days a week as follows (contact details: Dr Jo Tully, clinical research fellow, Institute of Child Health, London, tel 0171 242 9789 ext 2443, mobile tel 07957 316172, email j.tully@ich.ucl.ac.uk).

To: Slugger who wrote (8320)	1/17/1999 1:48:00 AM
From: aknahow	Read Replies (1) \| Respond to of 17367

Sorry for the last post. Cut and paste was sloppy with duplication. but this stuff comes from U.K. phls site. Note this one on reduction of mortality by early notification!! 2. Media reports of Meningitis There has been a lot of media coverage of meningitis cases over the Christmas and New Year. There are two main groups of meningococcal meningitis – Group B and C. The current vaccine is only effective against Group C. The best protection is to be able to recognise the symptoms of meningitis and seek urgent medical attention if you suspect someone has the disease. We know that we could reduce the deaths by as much as 50% if early recognition and appropriate treatment are provided.