- Ammoniated Beef Treatment Questioned
- FDA to Tighten Standards on Human Trials
- U.S. Cocaine Laced With Deadly Horse Drug
- N.H. Woman Swallowed Anthrax, Perhaps From Drum
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Ammoniated Beef Treatment Questioned
Despite being linked to repeated incidents involving potentially deadly E. coli and salmonella, a major U.S. meat treatment method continues to be used with government approval, The New York Times reveals.
Beef Products, Inc., which supplies processed meat to McDonald's, Burger King and the U.S. school lunch program, developed a process eight years ago that involves injecting beef with ammonia to banish the gastrointestinal bug E. coli bacteria from burgers. A study by the South Dakota-based company showed the process also killed salmonella, and the U.S. Department of Agriculture endorsed the idea, enabling the company to use fatty trimmings previously limited to pet food and cooking oil for humans.
The ammoniated trimmings are processed into "a mashlike substance frozen into blocks or chips" and used in a majority of hamburgers nationwide, the story says.
The USDA exempted Beef Products from routine testing of hamburger meat begun in 2007, The Times reported.
But government and industry records obtained by The Times show that in testing for the school lunch program, "E. coli and salmonella pathogens have been found dozens of times in Beef Products meat, challenging claims by the company and the U.S.D.A. about the effectiveness of the treatment," the newspaper said.
Beef Products maintains it tests samples of each batch shipped and that E. coli was detected in only 0.06 percent of the 2009 samples.
While no E. coli outbreak has been tied directly to Beef Products, the incidents point out problems within the USDA, The Times said. Also, salmonella-tainted meat that the school lunch program won't buy can still be sold to the general public, the paper said.
With food-borne illnesses a growing problem in the nation, the USDA told The Times it will look more closely at Beef Products. A recent E. coli outbreak was tied to a New York hamburger maker that used Beef Products and other suppliers, and the USDA included Beef Products in its recall.
"This will continue to be our approach going forward," the department said.
FDA to Tighten Standards on Human Trials
Makers of medical devices will face tougher approval standards under new guidelines being developed by the U.S. Food and Drug Administration.
In the face of two studies critical of the FDA's approval processes, an agency official told The New York Times that it will urge manufacturers to develop well-defined targets for their trials on humans and measure them more closely.
Dr. Jeffrey Shuren, acting director of the Center for Devices and Radiological Health, told The Times that in late 2007 the agency started making improvements, which included a checklist for gauging the scientific merits of manufacturers' proposed designs. But he said he expects the agency will put out guidelines in the next year with explicit expectations regarding the scientific data that manufacturers present in clinical studies.
His comments preceded Tuesday's release of two studies that found the approval processes for high-risk heart devices such as coronary stents, pacemakers and implanted defibrillators suffered from a lack of high-quality data. Both studies reviewed clinical trials submitted for FDA approval from 2000 to 2007.
One study was conducted by the FDA and researchers from the Beth Israel Deaconess Medical Center in Boston. The other, published in The Journal of the American Medical Association, was led by researchers at the University of California, San Francisco.
The FDA-led study found enough problems with the quality of data submitted to warrant making policy changes, Shuren said. "It is not acceptable, and that is the reason we are making the changes in the program we are making," he told The Times.