Health Highlights: April 19, 2010
WinCo Recalls Ground Beef FDA Targets Florida Lab Linked To Polo Pony Deaths Malaria Program's Effectiveness Unclear FDA Reconsiders Fate of Diabetes Drug Avandia: Report FDA Warns Generic Drug Maker Apotex No Evidence of Autism-Related Bowel Disease: Paper
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
WinCo Recalls Ground Beef
Ground beef sold by the western U.S. supermarket chain WinCo Foods has been recalled because of possible contamination with E. coli 0157:H7 bacteria, which can cause severe food poisoning.
The recall applies to fresh ground beef packed in plastic foam trays with a sale date between March 28 and April 9. Consumers with the meat should throw it out or return it for a refund. The company said no illnesses have been confirmed in connection with the recalled ground beef, CNN reported.
WinCo announced the voluntary recall after two samples of ground beef from its Modesto, Calif., store tested positive for E. coli 0157:H7. The U.S. Department of Agriculture is investigating the contamination.
The company has 71 stores in California, Idaho, Nevada, Oregon, Utah and Washington, CNN reported.
FDA Targets Florida Lab Linked to Polo Pony Deaths
The U.S. Food and Drug Administration is seeking an injunction against a Florida company that made a vitamin mixture linked to the deaths of 21 polo ponies last year.
The FDA wants to permanently ban Ocala-based Francks Compounding Lab from creating drugs using pharmaceutical ingredients not approved or reviewed by the FDA, The Palm Beach Post reported.
The complaint for injunction was filed Friday in the U.S. District Court for the Middle District of Florida.
"The FDA is concerned that the company's continued compounding practices pose a significant public health risk," the agency said in a news release. "Animal drugs compounded from bulk ingredients do not undergo FDA review and are not approved by the agency."
In compounding, ingredients are combined, mixed or altered to create a custom medication. The polo ponies overdosed on selenium contained in a vitamin mixture created by Franck's Lab Inc, the Post reported.
Malaria Program's Effectiveness Unclear
The effectiveness of an anti-malaria program that's costing billions of dollars is being questioned.
Last year, more than $1.8 billion was spent on fighting the mosquito-borne disease in Africa, a 10-fold increase since 2004, according to a report released Monday by UNICEF and Roll Back Malaria, a United Nations-led partnership, the Associated Press said.
Under the program, more than 150 million insecticide-treated bed nets have been produced and more than 160 million drug treatments have been purchased. Based on mathematical modeling, the bed nets prevented malaria in more than 10 million children, according to the U.N.
But questions exist about how many people are actually sleeping under bed nets. For example, estimates for children in different countries range from 4 percent to 62 percent, UNICEF said. In some countries, rich people are more likely to receive bed nets, even though poor people are at greater risk from malaria, the Associated Press reported.
The UNICEF report also said there's little evidence that sick children are receiving malaria drugs.
FDA Reconsiders Fate of Diabetes Drug Avandia: Report
GlaxoSmithKline's diabetes drug Avandia could be removed from the U.S. market if the U.S. Food and Drug Administration decides to halt a safety study involving thousands of patients.
In recent years, a number of studies have linked Avandia to an increased risk of heart attacks. The safety study, approved by the FDA in 2007, is comparing Avandia with a Takeda Pharmaceutical diabetes drug called Actos, the Wall Street Journal reported.
A number of experts have said it's unethical to compare a drug with known heart risks to an apparently safer drug and have also called for Avandia to be taken off the market. But the FDA has ignored those concerns until now, the newspaper said.
The agency has asked the Institute of Medicine, a U.S. government scientific panel, to review the ethics of the safety study. One FDA official said that if the study is stopped, the agency would also consider halting sales of Avandia in the United States, the Journal reported.
FDA Warns Generic Drug Maker Apotex
A warning letter about manufacturing violations has been sent to Canadian generic drug maker Apotex, says the U.S. Food and Drug Administration.
The violations include charred particles in a diabetes drug, contamination of an antihistamine, and drug cross-contamination due to inadequate cleaning of manufacturing equipment, The New York Times reported.
In addition, Toronto-based Apotex failed to notify the FDA in a timely manner about such problems, according to the agency.
Apotex did not respond to requests from the Times for comment about the FDA warning letter. The company is Canada's largest drug maker and the eighth-largest provider of generic drugs in the United States. Apotex drugs were used to fill 94 million prescriptions in the United States in 2009, according to drug industry research firm IMS Health.
No Evidence of Autism-Related Bowel Disease: Paper
A bowel disease supposedly linked with autism may not actually exist, says a new study.
The disease, autistic enterocolitis, was noted in a discredited paper published about a dozen years ago. The paper, which suggested a link between the measles vaccine and autism, has since been retracted by The Lancet medical journal.
In this new article, reporter Brian Deer asked independent experts to take a closer look at autistic enterocolitis. They failed to find any evidence that it's a real disease, the Associated Press reported. Deer's article appears in the British Medical Journal.
Several studies have found an association between inflamed bowels and autism, but "any firm conclusion would be inadvisable," Sir Nicholas Wright, from the Barts and the London School of Medicine and Dentistry, wrote in an accompanying editorial in the journal, the AP reported.