UPI NewsTrack Health and Science News

CHICAGO, Sept. 28 (UPI) -- FDA clinical trial oversight blasted WASHINGTON, Sept. 28 (UPI) -- A new report says the Food and Drug Administration is failing to properly keep an eye on the thousands of U.S. clinical trials.

A review by Department of Health and Human Services Office of Inspector General Daniel R. Levinson found that federal health officials didn't even know how many clinical trials were being conducted, The New York Times said Friday.

The report said the FDA has 200 inspectors to police an estimated 350,000 testing sites. It estimated that only 1 percent of all clinical trials were audited between 2000 and 2005. The FDA also was faulted for failing to make sure that any problems found are properly addressed.

The FDA oversees the safety of trials by companies seeking approval to sell drugs or devices. There is no federal oversight for private, noncommercial trials, the newspaper said.

The inspector general's report calls for the creation of a comprehensive database of all clinical trials, a federal registry of clinical trial inspectors and increased legal oversight.

Lung cancer research looks at women WASHINGTON, Sept. 28 (UPI) -- U.S. researchers and women's health advocates want more federal funding for research on women who get lung cancer.

Meeting with lawmakers on Capitol Hill last week, Phyllis Greenberger, head of the Society for Women's Health Research, said new research shows differences in susceptibility, progression and responsiveness to treatment in lung cancer between women and men.

The Lung Cancer Alliance said lung cancer research is severely underfunded. The disease kills more than 70,800 women a year, 30,000 more than breast cancer. The National Cancer Institute in 2006 spent approximately $13,519 for research on breast cancer per death compared to $1,638 on research per lung cancer death.

A study in the Journal of Clinical Oncology last February found that about 20 percent of lung cancer cases in women occur in nonsmokers, compared to 8 percent in men.

Research is under way to examine whether the biological traits of being a woman or a man impacts lung cancer susceptibility, the Society for Women's Health Research said Friday in a release.

India's HIV tests under scrutiny WASHINGTON, Sept. 28 (UPI) -- An AIDS specialist for the World Bank said defective HIV testing kits were distributed in India as recently as April.

Kunal Saha told The Washington Post that he has been warning officials for months about the problem in India, where nearly 3 million people are believed to have HIV.

The World Bank said it is finalizing a report on the issue but Saha said he is taking the issue public because of the danger of HIV being transmitted in India is too great, the newspaper said Friday.

World Bank public health specialist Kees Kostermans said India's National AIDS Control Organization has assured him that substandard test kits were no longer in use.

Saha, who traveled in India in March and April, said he found a document suggesting that questionable kits were available for use at the time. Kostermans told the Post that he believed Saha was mistaken about the origin and make of the test kits he saw.

"It is in nobody's interest to have poor-quality test kits," Kostermans told the newspaper.

EPA says eastern U.S. skies are cleanier WASHINGTON, Sept. 28 (UPI) -- The Environmental Protection Agency says the air in the eastern United States is significantly cleaner now than it was in 1990.

Smog forming emissions of nitrogen oxides (NOx) from power plants and industry in 19 eastern U.S. states and the District of Columbia are down seven percent from 2005, 60 percent from 2000 and 74 percent from 1990, the NOx Budget Trading Program annual said Thursday.

The report said reduction of nitrogen oxides, a precursor to smog, has helped reduce ground-level ozone concentrations an average of five to eight percent in the eastern United States in the last three years.

The largest reductions occurred in the mid-central region, which includes Illinois, Indiana, Kentucky, Ohio, and West Virginia, the report said.

Copyright 2007 by United Press International

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