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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . November 6th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Hemophilia Therapy - Republic of Georgia develops successful national hemophilia program

Measles Vaccine - Measles control program reduces measles deaths by 20% in Africa

Natural Products - Russian ethnomedicinal plants more cytotoxic than established therapies

Neural Tube Defects - Prevalence of spina bifida and anencephaly declining in U.S. minorities

Sexually Transmitted Diseases - Phone call more cost-effective than counseling for prompting follow-up clinic visits

Adverse Drug Reaction - Agencies issue alert on Menactra meningococcal vaccine and Guillain Barre syndrome

Adverse Drug Reaction - Agency issues public health advisory on Strattera (atomoxetine) for attention deficit disorder

Adverse Drug Reaction - Anaphylaxis risk for rocuronium comparable to vecuronium

Antimicrobials - Studies add new findings to antimicrobials body of knowledge

Antipsychotics - Adherence to clozapine therapy improved by weekly clinician visits

Asthma - FDA approves Zyflo for prevention and treatment of asthma

HIV/AIDS Vaccines - Researchers' findings advance HIV/AIDS vaccines research

Asthma - New study on childhood asthma shows home-based interventions are cost effective

Bacterial Vaginosis - Vaginal IL-8 levels not associated with bacterial vaginosis during pregnancy

Biomedical Engineering - Nitric oxide-releasing coatings reduce implant-associated infections

Bioterrorism - U.S. NIH awards $4.6 million challenge grant for R&D of intranasal anthrax vaccine

Blood Glucose - Approved IFCC recommendation for reporting blood glucose results released

Blood Safety - New system increases platelet availability and patient safety

Blood Safety - Photochemical treatment inactivates Leishmania in platelet concentrates

Breast Cancer - U.S. FDA approves Aromasin for adjuvant treatment of early breast cancer in postmenopausal women

Breast Cancer - U.S. Food and Drug Administration approves InSite HER-2/neu (CB11) monoclonal antibody

Cancer Risk Factors - Red meat and meat cooked at high temperatures associated with higher cancer risk

Cancer Risk Factors - Susceptibility to carcinogens increased with early-life exposure

Cancer Therapy - Guidance documents for marketing approvals of anticancer drugs in Europe need rewriting

Cancer Vaccines - Studies describe new findings in cancer vaccines research

Cardiovascular Disease - CV disease prevention guidelines should focus on older patients

Childhood Obesity - Australian general practitioners tackle childhood obesity in LEAP program

Childhood Obesity - Time watching TV or playing outdoors not linked to BMI in preschool children

Clinical Trials - Completing phase 3 study plan of testosterone for HSDD is result of U.S. FDA meeting

Clinical Trials - Stem cell products company announces clinical hold on enrollment in CB001 study

Clinical Trials - U.S. FDA grants clearance to conduct clinical studies for myelodysplastic syndrome

Clinical Trials - U.S. phase II trial for cholesterol-lowering drug, FM-VP4, cleared

Contraception - Increased access to emergency contraception does not increase sexual risk behavior

DNA Research - U.S. NIH medical sciences institute awards grant for biomolecule labeling method

Defibrillators - U.S. Food & Drug Administration approves new implantable defibrillator system

Diabetes Therapy - Lack of infrastructure limits access to care for patients with insulin-requiring diabetes

Diagnostics - Bacterial 16S rDNA universal primers diagnose partially treated meningitis

Diagnostics - ELISAs are accurate for screening community levels of Cryptosporidium infection

Diagnostics - FDA clears use of Stratus CS Acute Care D-dimer assay as aid in VTE diagnosis

Diagnostics - PCR-SSCP rapidly identifies Neisseria meningitidis

Diet & Nutrition - New U.S. Dept. of Agriculture computer-based MyPyramid food guidance system for children applauded

Diet & Nutrition - Problems with Cochrane reviews of diet and chronic disease examined

Drug Development - Biotech company meets with U.S. FDA for IND application on colon cancer drug

Drug Development - Clinical endpoints achieved in phase II trial of anti-nausea drug

Drug Development - European and U.S. orphan drug designation granted for cardiogenic shock medication

Drug Development - FDA grants fast track designation for arimoclomol in ALS

Drug Development - Pharmaceutical company to request end of phase II meeting with U.S. FDA for CF drug

Drug Development - Phase I trial to be initiated for AVN944 to treat hematological malignancies

Drug Resistance - Single MRSA clone spreading transregionally between drug users in Switzerland

Drug Safety - Healthcare providers notified of adverse events from Menactra meningococcal vaccine

Epidemiology - Widespread B. cenocepacia clone identified in CF patients in Czech Republic

Fitness & Wellness - Athletes and nonathletes with similar body fat have same lipidemic profiles

Fluorosis - Serum fluoride levels correlate with prevalence of skeletal fluorosis

Food-Borne Illness - Benzo(a)pyrene induces anemia and splenomegaly in NZB/WF1 mice

Gastroenterology - Gastrointestinal disease may be a risk factor for GI infection with Listeria

Genetics & Genomics - SNCG gene expression by demethylation a critical factor to malignant progress

Genital Herpes Vaccine - Majority of parents would allow children to be vaccinated against genital herpes

Genital Warts - New drug application filed with U.S. Food and Drug Administration for Polyphenon E Ointment

Geriatrics - Pneumococcal immunizations more likely in nursing homes with vaccine programs

Glioblastoma Therapy - Radiation plus IL-13 receptor-targeted cytotoxin kill glioblastoma cells

Gynecology - Pathology of NovaSure impedance-controlled endometrial ablation system described

HIV/AIDS Diagnostics - Plasma RT assay is an affordable alternative for HIV viral load determination

HIV/AIDS Drug Development - Protease inhibitors plus mefloquine have marked synergy against HIV-1

HIV/AIDS HAART - Cotrimoxazole prophylaxis prevents complications prior to HAART initiation

HIV/AIDS HAART Prophylaxis - Adherence to HAART prophylaxis is low in victims of suspected sexual abuse

HIV/AIDS Pathogenesis - Saliva HIV levels more influenced by blood HIV RNA levels than oral inflammation

HIV/AIDS Pathogenesis - Vpr-mediated cell cycle arrest is important for HIV replication and pathogenesis

HIV/AIDS Prophylaxis - Single-dose nevirapine within 24 hours of birth protects against HIV-1 infection

HIV/AIDS Transmission Risk - Second trimester amniocentesis does not increase vertical HIV transmission risk

HIV/AIDS Vaccines - Research add new data to HIV/AIDS vaccines body of knowledge

HIV/AIDS-Associated Infection - TSP/HAM should be considered in HIV patients with myelopathy and normal CD4 counts

HIV/AIDS-Related Infection - HIV-1 infection is not a risk factor for amebiasis

Heart Failure - Higher levels of CRP are associated with more severe heart failure

High Triglycerides - Pharma company launches Omacor to treat very high levels of triglycerides

Human Papillomavirus - Recent findings illuminate research in human papillomavirus

Hurricane Relief - U.S. Department of Health & Human Services awards grants to support minority health

Imaging - Cancer-focused imaging company withdraws PMA supplement submission to U.S. FDA

Imaging - U.S. Food & Drug Administration clears new fluoroscopic imaging system, called the OEC Altitude

Immune Thrombocytopenic Purpura Therapy - Disseminated intravascular coagulation is rare complication of anti-D IGIV therapy

Influenza - AIV TX/04 pathogenicity increased by AA insertion at hemagglutinin cleavage site

Influenza - H5N1 influenza virus is nonpathogenic in ducks

Influenza - Oral lactoferrin and lactoperoxidase attenuates pneumonia in influenza virus infection

Influenza Vaccine - U.S. NIAID and MedImmune join forces to develop potential pandemic influenza vaccines

Influenza Vaccines - New research in the area of influenza vaccines detailed

Keratoplasty - U.S. Federal Aviation Administration approves use of conductive keratoplasty for pilots

Laboratory Biosafety - Biosafety level 3 facilities safeguard from SARS-CoV-infected autopsy specimens

Lead Poisoning - Low blood lead levels affect cardiovascular functioning in children

Legal Issues - Appeals court upholds patent infringement finding on BenchMark, Discovery claims

Malaria - Puddles created by the 2004 tsunami facilitate increased breeding of malaria vector

Malaria Therapy - Quinine monotherapy does not effectively treat malaria in pregnant women

Malaria Vaccines - Recent findings in malaria vaccines described

Medical Devices - Life science company enters two agreements with TZ Medical for the acquisition cardiac devices

Medical Devices - Light-based skin therapy company receives U.S. government clearance for hair removal

Medical Devices - Medical devices company receives U.S. FDA clearance for extraction catheter

Medical Devices - Premarket approval application submitted to U.S. Food and Drug Administration for rhBMP-2

Medical Devices - U.S. FDA grants approval for tiny blood glucose monitor, Sidekick

Medical Errors - Language increase risk of serious medical events in hospitalized children

Medical Errors - Professionals alerted to reported medication errors between Topamax, Toprol-XL

Mental Health - Placebos should be used for testing of new psychiatric disorder agents

Microbicide - Vaginal detergent-type microbicide causes inflammatory cell infiltration at epithelial surface

Microsporidia Infection - Early symptoms of microsporidia infection may resolve even though microsporidia may persist

Myelodysplastic Syndrome - Revlimid action date for U.S. Food and Drug Administration priority review of NDA extended

Nanotechnology - Safety evaluation of nanomaterial exposure suggested

Nosocomial Infection - Nosocomial bacteremia in neonates is related to poor standards of care

Obesity Diagnosis - Waist circumference criteria for abdominal obesity not applicable to all populations

Occupational Health - Steelworker cohort in Korea exhibits excess mortality for some processes

Parasitology - Flea larvae have higher survival when parasitizing underfed hosts

Personnel - WHO health expert David Nabarro named work on avian, human influenza response

Pertussis Vaccines - Data advance knowledge in pertussis vaccines research

Pneumococcal Vaccines - Reports describe recent advances in pneumococcal vaccines research

Polio Vaccines - Studies describe new findings in polio vaccines research

Product Licensing - Oncology drug acquired from SD Pharmaceuticals through exclusive license agreement

Proteomics - More proteins accumulate in stored supernatants of nonleukoreduced than in leukofiltered RBC products

Psoriasis - European Commission grants approval of Remicade for plaque psoriasis

Psoriatic Arthritis - Humira receives U.S. Food and Drug Administration approval for treatment of psoriatic arthritis

Radiology - Regulatory requirements for human subjects in radiology research outlined

Regulatory Approvals - Marketing clearance for the ULTRIO assay on the TIGRIS system "unlikely" this year

Research Funding - Cell culture developer receives $3.96 million U.S. DoD contract to continue R&D

Research Funding - Gene researcher awarded $4.9 million U.S. NIH contract for knockout mouse materials

SARS - Acute SARS-CoV infection contributes to initial DC and T-cell subset reduction

SARS - Imported cases after nosocomial infection were major cause of SARS infections

SARS Outbreaks - Data advance knowledge in SARS ouTBreaks research

Salmonellosis Therapy - Beta-lactam resistance investigated in Enterobacteriaceae

Sepsis Prevention - Six sigma strategies reduce incidence of catheter-related bloodstream infections

Sexual Dysfunction - Testosterone therapy in women reviewed

Shigellosis Outbreak - Researchers report shigellosis outbreak in swimmers in freshwater lake

Sleeping Sickness - Sleeping sickness epidemic spreading in Uganda

Smallpox - Vaccine, previously left unused in WHO eradication program, provides efficient protection

Staffing - Concentra secures military contract to provide on-site occupational medicine services

Stem Cell Transplantation - New research in the area of stem cell transplantation detailed

Tuberculosis Risk Factors - Population-based TB risk factors for Tibetan refugees in India reported

Type 2 Diabetes - Personal characteristics affect quality of life in diabetic patients in Iran

Ultrasonography - Greater standardization of ultrasound backscatter measurement methods needed

Variant Creutzfeldt-Jakob Disease Prion - Transmission risk of v-CJD prion during abdominal surgery is currently unquantifiable

Vibrio Fluvialis -  Vibrio fluvialis isolated from pediatric patients with diarrhea

Violence - Almost 1.7 million children at risk from loaded firearms in U.S.

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