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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . March 7th, 2004

Non-Subscriber - Summaries Only

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

SARS - 2003 Outbreak of severe acute respiratory syndrome in Beijing summarized

Drug Resistance - Vancomycin-resistant Staphylococcus aureus isolate found in Pennsylvania

Fungal Infection - Manifestations and treatment of dematiaceous fungal infections described

Head and Neck Cancer - IL-13 receptor alpha 2 chain is marker of head and neck cancer

Pharmacokinetics - Pharmacokinetics of emtricitabine in HIV-infected children determined

Acne - FDA approves Syneron Aurora for dermatological use

Acne - FDA urged to crack down on Internet sales of isotretinoin

Advanced Melanoma - FDA approves Genasense NDA

Alcoholism - Quick fixes for dangerous youth drinking can work

Antimicrobial Drug Resistance - Genetic element linked to streptococcal macrolide resistance characterized

Avian Influenza - Avian flu virus continues to spread in Asian countries

Avian Influenza - Ban won't be lifted on Thai poultry until bird flu eradicated

Avian Influenza - U.N. says bird flu has not mutated to potent, new form; downplay tests in pigs

Basal Cell Carcinoma - Risk of basal cell carcinoma is increased by alcohol intake

Breast Cancer - FDA accepts NDA with priority review for RSR13

Cancer Therapy - Proteasome is target for cancer therapy

Chronic Obstructive Pulmonary Disease - FDA approves Spiriva HandiHaler

Colorectal Cancer - FDA approves Erbitux for metastatic disease

Complementary and Alternative Medicine - FDA issues regulation prohibiting sale of dietary supplements containing ephedra

Complementary and Alternative Medicine - Herbal medicine guidelines issued

Contraception - Systematic analyses of randomized trials show dose and effect rule mifepristone

Cosmetic Procedures - Clinical results from botulinum toxin type A study announced

DNA Damage -  Saccharomyces cerevisiae 14-3-3 proteins respond to DNA damage

Diabetes - Patent granted for advanced insulin pump infusion sets

Diagnostics - Method to detect glimepiride in human plasma developed

Diet and Nutrition - Carbohydrates, and more of them, blamed for weight gain, especially in women

Diet and Nutrition - Prenatal mercury exposure via mother's diet can impair certain brain functions

Diet and Nutrition - Science behind U.N. global obesity attacked

Drug Testing - Drugs-of-abuse testing products receive FDA clearance

Electrophysiology - SonoPrep skin permeation device receives FDA marketing clearance

Environmental Health - Detailed studies set the standard for evaluating fertility and the environment

Environmental Toxins - CDC asking EPA to test suspect environmental contaminant in Sierra Vista

Finance - Campath continues steady sales progression

Finance - Humana shows improved fourth quarter and year end results

Finance - SECEBT receives nearly $1 million for bioterror studies

Food-borne Illness -  Enterobacter sakazakii thermally inactivated in rehydrated infant formula

Food-borne Illness - Scientists developing bacteria detection device

HIV/AIDS - HIV discrimination case settled by surgeon

HIV/AIDS Epidemiology - AIDS rising in black male college students

Healthcare Costs - Healthcare spending increased to $1.7 trillion in 2003

Healthcare Economics - Spending growth projected to nearly double in the next decade

Heart Disease - Role of mineralocorticoid receptor antagonists for heart failure reviewed

Heart Failure - U.S. clearance granted for AxSYM BNP test

Hip Arthroplasty - MIS hip procedure granted U.S. patent

Hormone Replacement Therapy - FDA approves first transdermal gel for estrogen therapy

Hormone Replacement Therapy - FDA updates hormone replacement warnings

Hypertension & High Cholesterol - FDA approves Caduet as dual therapy

Imaging - Imaging company reports order for CTLM system from Axies Medical

Infant Mortality - Infant deaths up in U.S. for first time since 1958

Infant Mortality - U.S. life expectancy at all-time high, but more infants die before 28 days

Infection Control - National nosocomial infections surveillance program reduces infection rate

Influenza - Availability of work site vaccinations increases rate of adult flu shots

Injury Prevention - Studies: Kids still riding in front seats

Laser Therapy - FDA clears Waterlase for bone, periodontal, soft tissue indications

Legal Issues - Soldier who refused anthrax vaccine off to Iraq

Lung Cancer - FDA approves Alimta-cisplatin combination

Lung Cancer - FDA panel recommends approval of new CAD system

Malaria Vaccine - Apical membrane antigen 1 mediates merozoite attachment to host cells

Malaria Vaccine - Malaria vaccine developments reviewed

Medical Devices - Medical device regulation complicated by multiple agency involvement

Medical Errors - Study finds inappropriate medication prescribing for elderly patients

Medicare Management - Northwestern Memorial Hospital contracts with CodeCorrect

Medicare Reform - HIP Health Plan of New York lowers Medicare benefit costs

Menopause - Cenestin 0.45-mg tablets approved by FDA

Mergers and Acquisitions - U.S. Federal Trade Commission challenging merger of two Chicago hospitals

Minority Health - U.S. report downplayed health problems

Muscular Dystrophy - FDA Orphan Drug Status filed for muscular dystrophy treatment

Nearsightedness - Panel recommends FDA approval of Artisan/Verisyse lens

Nicotine Addiction - Restaurant smoking bans more likely in affluent neighborhoods

Nutrition - Starvation in mothers can program children for obesity

Occupational Health - Improved emission model of computational fluid dynamic simulation proposed

Ophthalmic Disease - FDA extends Vitrase New Drug Application by 90 days

Ophthalmology - "Dry eye" in women may be linked to sex hormone levels

Osteoarthritis - FDA approves Orthovisc; Anika to receive $20M milestone payment

Outbreaks -  Salmonella found in sesame seed products

Pediatrics - Gender differences exist in mutual gaze behavior in young infants

Pharmacokinetics - Bioequivalence method for topical clobetasol 17-propionate developed

Policy - Political economy of FDA drug review policy analyzed

Prescribing Practice - CDC: Seniors prescribed dangerous drugs in about 8% of doctor visits

Preterm Delivery - Premature births among African Americans in North Carolina are still high

Prostate Cancer - Researcher receives $9 million grant to launch gene therapy trials

Public Health - Multisite violence prevention project design done by committee

Regulatory Issues - Researchers urge that ideology and bureaucracy be kept out of science

Streptococcus Vaccine - Potential vaccine antigens of Streptococcus pyogenes identified

Tissue Valve Calcification - FDA approves ThermaFix process

Toxicology - Exogeneous hormone rescues bromodichloromethane-induced pregnancy loss in rats

Transfusion Medicine - Company announces Galileo submission to FDA

Transplant Medicine - Ethicists say troubling living donor cases need guidelines

Tuberculosis Vaccine - Defective M. tuberculosis provides greater TB immunity than BCG vaccine

West Nile Virus - WNV infection in kidney transplant recipient reported

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