Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
EPA Advisors Rule Teflon Chemical a Likely Carcinogen
A chemical used in the manufacture of Teflon should be considered a likely carcinogen, a group of scientific advisers to the Environmental Protection Agency ruled Wednesday.
The Associated Press reported that the vote was unanimous, and no major changes will be made to the group's finding. The chemical, known as perfluorooctanoic acid (PFOA), is a processing aid used in the making of fluoropolymers, which are used in many products, including nonstick cookware.
The board also sent along to EPA Administrator Stephen Johnson a letter explaining the rationale behind its decision and clarifying the scope of dissent among the group's members, the AP reported.
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Withdrawn MS Drug to Return in Clinical Trial
Federal regulators have approved the use in a clinical trial of Tysabri, a multiple sclerosis (MS) drug voluntarily withdrawn from the market a year ago due to safety concerns, the Associated Press reported Wednesday.
The drug's makers, Biogen Idec Inc. and Elan Corp., said patients would be invited to re-enroll in the study, which was halted last February.
The two companies also expect a decision from the U.S. Food and Drug Administration by late March on an application submitted last September requesting that Tysabri be allowed back onto the market with revised labeling and a strategy to address patient risks.
Tysabri was voluntarily withdrawn from the market after two patients with MS and a third with the intestinal disorder Crohn's disease developed a serious condition called progressive multifocal leukoencephalopathy (PML) after taking the drug. The Crohn's patient and one of the MS patients died from the illness.
According to officials at Cambridge, Mass.-based Biogen Idec, any return of Tysabri to the market would involve new labeling warning of potential risks to patients with weakened immune systems, who are most at risk for PML.
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Genentech Seeks Additional Indication for
Herceptin
Drug company Genentech on Thursday filed an supplemental application with the U.S. Food and Drug Administration to approve an additional indication for the drug Herceptin in treating early-stage operable human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Herceptin is already approved in the United States as a first-line treatment for HER2-positive metastatic breast cancer in combination with paclitaxel, or as a single treatment for relapsed or refractory HER-2 positive metastatic breast cancer.
Genentech requested that the FDA give priority review designation to the application, which is based on an analysis of more than 3,000 patients. It found that the addition of Herceptin to chemotherapy improved disease-free survival and overall survival compared to chemotherapy alone and reduced by 52 percent the risk of breast cancer recurrence in women with early-stage HER-2 positive breast cancer.
In other news, the FDA accepted Merck's new drug application for JANUVIA (sitagliptin phosphate), an investigational drug for type 2 diabetes. If the FDA approves the application, the drug would be among the first in a new class of oral medications called DPP-4 inhibitors that enhance the body's own ability to lower elevated blood sugar levels.
Merck said it expects FDA action on the application by mid-October.
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Germany Latest Country to Report Bird Flu
Germany is the latest European Union (EU) country to report the presence of bird flu after two wild swans on the Baltic Sea island of Ruegen were found to be infected with the deadly H5N1 virus.
The Swedish government has ordered farmers to keep their poultry indoors in order to protect them from bird flu infection, Bloomberg news reported.
Austria, Greece, Italy, and Slovenia are the other EU countries that have reported cases of the H5N1 virus.
Hungarian officials said tests are being conducted on the body of a duck found in Budapest and the results will be known within seven days, Bloomberg reported.
In other news, Indonesian officials said the number of human cases of bird flu are increasing, with eight reported so far. That's second only to Turkey, which has reported 12 human cases, all contracted via bird-to-human transmission of the virus.
Bird flu is currently present in southeast and central Asia, eastern and central Europe, and western Africa. The continuing spread of the virus increase the risk that it will develop into a form easily transmitted between humans, experts say.
So far, 91 of the 169 people known to have been infected with bird flu have died, according to the World Health Organization.
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FDA Defines Whole Grains
In order to help consumers select cereals and breads that have heart-healthy whole grains, the U.S. Food and Drug Administration issued new guidelines Wednesday on what qualifies as "whole grain" on food labels.
The FDA said it considers whole grains to, "include cereal grains that consist of the intact, ground, cracked or flaked fruit of the grains whose principal components - the starchy endosperm, germ and bran - and present in the same relative proportions as they exist in the intact grain. Such grains may include barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, wheat and wild rice."
It's the first time that the FDA has attempted to define whole grains, the Associated Press reported.
Barbara Schneeman, director of the FDA's office of nutritional products, labeling and dietary supplements, said consumers need a consistent definition for whole grains.
"Using the term multigrain or seven-grain doesn't necessarily mean that product contains whole grains," Schneeman told the AP.
According to U.S. dietary guidelines, three servings of whole grains a day can reduce the risk of heart disease and type 2 diabetes.
