Chinese Plant That Made Suspended Blood Thinner Not Licensed for Pharmaceutical Manufacturing
The Chinese manufacturing plant that supplies a great amount of the active ingredient in a blood thinner associated with four deaths in the United states isn't even certified by its own government to make drugs and other pharmaceutical products, the New York Times reports.
This revelation comes only a few days after the U.S. Food and Drug Administration admitted it violated its own policy by not having inspected the plant before allowing pharmaceutical company Baxter International, which uses ingredients from the Chinese plant, to market the blood thinner heparin in the United States, the Times said.
On Feb. 11, Baxter International suspended sales multi-dose vials of heparin after disclosing that 4 deaths and 350 complications resulted from use of heparin. A spokesman for China's State Food and Drug Administration told the newspaper Friday that the plant in question was not a drug manufacturer but "a producer of chemical ingredients" and not licensed to make pharmaceutical products.
When will the FDA get around to inspecting the Chinese plant? Soon, the Times reports agency spokeswoman Karen Riley as saying. She didn't elaborate, but earlier in the week called the FDA's failure to inspect the plant a "glitch", the newspaper said.
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Meta-Study: Hispanics Have More Difficulty Controlling Glucose Levels
Confirming earlier studies, researchers at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. have found that Hispanics have a measurably more difficult time controlling their blood sugar.
Maintaining proper amounts of blood sugar (glucose) is a key element in controlling type 2 diabetes, which is estimated to affect more than 20 million Americans.
The study, which was underwritten in part by the U.S. Centers for Disease Control and Prevention, found that Hispanic patients with diabetes have glucose levels about 0.5 percent higher than Caucasians, according to a Wake Forest news release.
The test used for the analysis was the A1C test, which measures hemoglobin linked with glucose over a two-to-three month time period. The higher the A1C values, the more difficult it is for diabetes patients to control their blood sugar, the researchers said.
The researchers began with 495 studies over a 13-year period and narrowed their focus to 11 studies that comprised results of A1C tests for Hispanics and non-Hispanic whites.
"The Hispanic population has a high prevalence of diabetes and higher A1C than non-Hispanic whites," said Julienne Kirk, associate professor of family and community medicine at Wake Forest, and lead author of the study. "This further elucidates the health disparities that characterize the Hispanic population."
The results of the study are in the February issue of Diabetes Care.
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555 Americans Killed in All-Terrain Vehicle Accidents in 2006
At least 555 people died in 2006 from accidents involving all-terrain vehicles (ATVs), the U.S. Consumer Product Safety Commission said Thursday.
More than 100 children were among the fatalities, the agency said. It expects the numbers to climb as additional data arrive from hospitals and coroners across the country, the Associated Press reported.
While groups representing consumers and parents have said for years that the vehicles are unsafe, the industry that makes ATVs cites driver error, the wire service reported.
"ATVs have never been shown to be an unsafe product, but there have been bad decisions made by people sitting on the seat," said a spokesman for the Specialty Vehicle Institute of America.
In its annual analysis released Thursday, the CPSC said Pennsylvania has led the nation in ATV deaths since 1982, followed by California, West Virginia, Texas and Kentucky. At least one ATV fatality was reported in each of the 50 states.
In 2005, 666 confirmed ATV deaths were reported. And because the CPSC said it is still analyzing data for that year, the toll could rise to as high as 870, the AP reported.
On the day the report was released, the CPSC announced the recall of 95,000 Polaris-brand ATVs that had potentially defective control panels that could ignite, the wire service said.
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Nearly 1 in 3 U.S. Births Are C-Sections: Report
Nearly one in three American women who gave birth in 2005 did so by Cesarean section, the U.S. Agency for Healthcare Research and Quality said Thursday in its latest News and Numbers report.
The ratio was about one in five in 1995, the agency said in a prepared statement.
The report also noted that:
- Some 1.3 million women had C-sections in 2005, a 38 percent jump over the 800,000 performed in 1995.
- Vaginal deliveries in hospitals fell from about 3 million in 1995 to 2.9 million in 2005.
- Hospitals charged a combined $21.3 billion for patient stays involving vaginal deliveries in 2005, compared to $17.5 billion for those involving C-sections.
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Government-Issued Trailers for Hurricane Victims Pose Risks: CDC
Many of the trailers used to house Gulf Coast victims of hurricanes Katrina and Rita contain toxic levels of formaldehyde fumes, U.S. health officials said Thursday.
Officials from the Centers for Disease Control and Prevention said people living in the government-issued trailers should be moved out as soon as possible because tests showed that fumes from 519 trailers and mobile homes in Louisiana and Mississippi averaged about five times higher than levels found in most modern homes. In some trailers, the levels were nearly 40 times higher, prompting concerns that the residents could come down with breathing problems, the Associated Press reported.
The CDC urged the Federal Emergency Management Agency, which supplied the trailers, to move people from the trailers as quickly as possible, with priority given to families with children, elderly people, or anyone with asthma or other chronic respiratory problems.
"We do not want people exposed to this for very much longer," said Mike McGeehin, director of a CDC division that focuses on environmental hazards.
FEMA provided about 120,000 travel trailers to victims of the 2005 hurricanes Katrina and Rita. In 2006, some occupants began reporting headaches and nosebleeds. The complaints were linked to formaldehyde, a colorless gas with a pungent smell used in the production of plywood and resins, the AP said.
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A Month on Fast-Food Diet Damages Liver: Report
Otherwise healthy people who were asked to eat mainly fast food for four weeks and cut down on their physical activity quickly developed signs of liver damage and pre-diabetic insulin resistance, Swedish researchers report.
In the study, 18 slim, healthy men and women were asked to reduce their daily physical activity to 5,000 steps per day and to consume at least two fast-food meals per day, preferably from well known chain restaurants.
The goal: to double daily caloric intake and boost body weight by 10 to 15 percent and then observe the effects on the liver.
A second group of healthy adults were asked to continue on their normal diet.
As reported in the journal Gut, researchers at the University of Linkoping found that the participants' levels of a particular liver enzyme called alanine aminotransferase (ALT) spiked within a week of being on the fast-food diet and more than quadrupled during the four-week study period.
In fact, ALT levels reached concentrations that indicated liver damage in 11 of the 18 participants, the researchers said. One participant also developed signs of a condition called "fatty liver," where unhealthy levels of fat collect in the organ.
The participants on the fast-food regimen also showed a sharp rise in the fat content of their liver cells, which is commonly associated with insulin resistance. Cellular resistance to insulin boosts risks for diabetes and cardiovascular disease, the researchers noted.
None of these unhealthy effects were noted in participants who ate normal diets, the researchers added.
Overall, people on the fast-food/low exercise regimen gained an average of more than 14 pounds within 4 weeks, and one person gained more than 26 pounds in just two weeks, the researchers said.
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