"News That Keeps You Healthy"   

   Antibiotic in trials said to be toxic  

WASHINGTON, -- An FDA official has called for a Paris-based  
drug company to halt clinical trials of an antibiotic in  
children because it could be lethal, it was reported. Ketek,  
made by Sanofi-Aventis, is being tested in nearly 4,000  
infants and children in more than one dozen countries, in-  
cluding the United States. The drug is being tested as a  
possible treatment for ear infections and tonsillitis, The  
New York Times reported. Ketek -- which is approved for use  
only by adults -- has been reported to cause liver failure,  
blurred vision and loss of consciousness in adults. The  
Times said it had obtained internal memos sent by Dr.  
Rosemary Johann-Liang -- an official in the FDA Office of  
Drug Safety -- to other officials at the agency. "How does  
one justify balancing the risk of fatal liver failure  
against one day less of ear pain?" Johann-Liang asked in  
one of the memos. Sanofi-Aventis said on its Web site it  
is sponsoring four clinical trials involving children ages  
6 months to 13 years, the Times reported. The trials were  
approved by the FDA. However, the newspaper said FDA safety  
officials recently found there is growing evidence that  
Ketek is unusually toxic.   


            New predictor for lung cancer found  

CLEVELAND, -- U.S. researchers say they have found a prom-  
ising, novel biomarker that may predict the survival of  
people with advanced lung cancer. The researchers at the  
Ireland Cancer Center, operated by University Hospitals of  
Cleveland, say the biomarker can also predict a patient's  
response to treatment. Dr. Afshin Dowlati, a hematologist-  
oncologist at the Ireland Cancer Center, found patients  
with a low level of the biomarker intercellular adhesion  
molecule-1, or ICAM, had a better chance of survival and  
an increased response to chemotherapy. Dowlati analyzed  
data from a major national study and found the monoclonal  
antibody Bevacizumab (Avastin), in addition to standard  
therapy, was more effective than standard treatment alone  
for patients with advanced, non-squamous, non-small cell  
lung cancer. "We believe this research confirms a signifi-  
cant new prognostic marker in lung cancer," said Dowlati.  
"Previously, it has been a challenge to identify those  
patients that will respond best to treatment and what  
their outcomes will be. This biomarker appears to serve as  
a much better predictor than gender, patients' overall  
health and sites of metastases." The study was presented  
recently in Atlanta during the annual meeting of the  
American Society of Clinical Oncology.   



           BP drugs, birth defects link studied  

NASHVILLE, -- A study at Nashville's Vanderbilt Children's  
Hospital suggests a link to birth defects from some blood  
pressure drugs taken by pregnant mothers. The drugs have  
been thought to be safe in the first trimester of pregnancy  
but the study says serious birth defects were reported in  
about 7 percent of babies whose mothers took them, The  
Washington Post reported Thursday. The ACE inhibitor drugs  
carry a warning that pregnant women should not use them in  
the last two trimesters as they could cause kidney damage  
to the fetus. But the study, appearing in Thursday's New  
England Journal of Medicine, says ACE inhibitors early in  
pregnancy nearly tripled the risk of birth defects, The  
Post reported. Dr. William O. Cooper, who led the study,  
said pregnant women and their health-care providers should  
be aware of the findings so alternatives can be used to  
treat hypertension. A Food and Drug Administration official  
said while more data may be needed, the study is important  
enough to inform the public.