Health Highlights: May 19, 2006
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Gives Final Approval to Barley Health Claim
The U.S. Food and Drug Administration announced Friday that it has finalized a qualified health claim for an association between foods that contain whole grain barley and a reduced risk of coronary heart disease.
Permission to make that qualified health claim applies specifically to whole barley and dry milled barley products such as flakes, grits, flour, meal and barley meal that provide at least 0.75 grams of soluble fiber per serving, according to a statement from the FDA.
Under an interim final rule, the FDA began allowing the claim in December 2005 while at the same time accepting public comments on the rule for 75 days. There were no comments received that warranted changes to the final rule.
Scientific evidence indicates that including barley in a healthy diet can lower levels of LDL (“bad”) cholesterol and total cholesterol and help reduce the risk of coronary heart disease, the FDA said.
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Remicade Approved to Treat Children with Crohn’s Disease
The drug Remicade (infliximab) has been approved to treat children with active Crohn’s disease, the U.S. Food and Drug Administration announced Friday.
Remicade is a genetically engineered monoclonal antibody that reduces Crohn’s related inflammation of the bowel by blocking the action of tumor necrosis factor-alpha (TNF-a). The drug was initially approved in 1998 to treat Crohn’s disease in adults.
The approval is based on the results of a study of 112 children, ages 6 to 17, with moderately to severely active Crohn’s, who had poor response to conventional therapies. The number of children in the study who responded favorably to the drug was similar to that seen in an earlier study in adults with Crohn’s. The children’s study did not reveal any new safety concerns that are not currently listed on the drug’s label, the FDA said.
There have been no satisfactory treatments for children with Crohn’s disease who have moderate to severe disease activity and do not respond to conventional therapy, noted Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research.
“Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy,” he said in a prepared statement. “We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated.”
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WHO companies Wants Tighter Registration of Drug Trials
Drug firms and research organizations should register all human clinical drug trials from the outset in order to prevent negative findings from being kept secret, says the World Health Organization (WHO).
Currently, student loan calculator researchers conducting human drug trials can wait until the study is well along before reporting any results, BBC News reported.
The WHO has created a 20-point checklist outlining the kind of information that should be included in any registry of drug trials before they are started. It also plans to use a new registry platform to provide access to drug trial registries run by corporations, hospitals and institutions, which would have to meet certain WHO standards.
“Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants,” said Dr. Timothy Evans, assistant director general of the WHO.
Registration for the new WHO registry would be voluntary, but recent drug scares have prom