Health Headlines - May 20

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.

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."

WHO 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, 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 prompted growing pressure for more openness about medical research, BBC News reported.

Human Transmission Unlikely in 5 Indonesian Bird Flu Deaths

It's unlikely that human-to-human transmission of the H5N1 bird flu virus was responsible for the deaths of five family members in Indonesia, the World Health Organization (WHO) said Thursday.

It was the largest such cluster recorded.

"Current evidence doesn't suggest at all that the virus was passed between humans," Gina Samaan, a WHO field epidemiologist who investigated the deaths, told The New York Times.

The bird flu virus was found in a number of chickens, ducks and pigs in the northern Sumatra village of Kuba Sembelang, where the five victims lived.

There had been some speculation that the five deaths, reported this week, may have been caused by a mutated version of the H5N1 virus that was able to pass from person to person. A sixth family member died of flu-like symptoms but wasn't tested for the virus, the Times reported.

Experts fear that if the H5N1 virus does mutate into a form that's easily transmitted between humans, it could spark a worldwide pandemic that could kill millions.

Indonesian officials announced Friday that bird flu killed a 12-year-old boy from the eastern outskirts of Jakarta, bringing that country's death toll to 32, the Associated Press reported.

So far, bird flu has killed 123 people worldwide since 2003. Only Vietnam, with 42 victims, has a higher death toll than Indonesia.

Michigan Sperm Donor Passed on Rare Genetic Disease

A Michigan man who donated sperm passed a rare and serious genetic disorder -- severe congenital neutropenia -- to five children born to four couples, says a report published Friday in the Journal of Pediatrics. The disease puts the children at increased risk for infections and leukemia.

The four couples were clients of the same sperm bank, which said it has discarded all the remaining samples from that particular sperm donor and informed the man he's no longer allowed to donate sperm, the Associated Press reported.

The sperm bank was not identified in the article. It's not know how many children the sperm donor fathered, whether the donor was aware that he carried the disease before he donated sperm, or whether he was told about his condition after the sperm bank learned about it.

Sperm donors are routinely tested for the most common genetic disorders, such as cystic fibrosis and sickle cell anemia, but not for extremely rare diseases, the AP reported.

The five children are doing fine and leading healthy lives, but they have a 50 percent chance of passing the gene and the disease to their children, experts said.

Iowa Woman Has 'No Resuscitation' Order Tattooed on Chest

An 80-year-old Iowa woman who had "DO NOT RESUSCITATE" tattooed on her chest in February says she did it to make her wishes perfectly clear in case she becomes incapacitated.

"People might think I'm crazy, but that's OK. Sometimes the nuttiest ideas are the most advanced," Mary Wohlford told the Associated Press.

Legal and medical experts are not sure her tattoo would amount to a legally binding document in an emergency room or in court.

Dr. Mark Purtle of the Iowa Methodist Medical Center in Des Moines told the AP that state law spells out when caregivers are permitted to end life-sustaining measures and a tattoo doesn't carry any weight.

Purtle said people should have a living will or an advanced directive and should discuss their wishes with their family. Wohlford does have a living will hanging on the side of her refrigerator.