Health Highlights: Aug. 28, 2004
FDA Experts Keen on Blindness Drug Vaccine Maker Reports New Problem Hospital Device Recalled After Children's Deaths Vioxx Heart Risk Finding Re-Ignites Debate U.S. Food Panel Urges More Whole Grains, More Exercise
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Experts Keen on Blindness Drug
A new drug that fights a form of age-related macular degeneration (AMD), a leading cause of blindness in the elderly, won applause if not approval from a panel of advisors to the U.S. Food and Drug Administration.
The panel did not formally vote to approve Macugen, made by Eyetech Pharmaceuticals. However, eye doctors were impressed by the research, according to an account by the Associated Press.
Macugen treats what is known as the "wet" type of AMD, where blood vessels cause blindness by forming behind the retina. The condition strikes an estimated 1.6 million older Americans, but experts believe that, as the population ages, some 6.3 million will suffer from the disorder by 2030.
In a study of 1,186 patients, Macugen slowed progressive vision loss, FDA medical officer Jennifer Harris told the advisory committee Friday. Those given a 0.3 milligram dose every six weeks suffered 15 percent less vision loss than untreated patients, according to the AP account.
The drug did not improve eyesight, however.
Vaccine Maker Reports New Problem
A day after it announced that it was delaying release of its flu vaccine, Chiron Corp. confirmed Friday that it was investigating possible problems with another type of vaccine in Brazil.
The New York Times reports that health officials in Brazil have stopped using Chiron's triple vaccine against measles, mumps, and rubella (MMR) after an unusually high number of children experienced allergic reactions to the jab.
At least 125 children suffered from the reactions, which ranged from rashes to anaphlyactic shock, a life-threatening condition.
The Times reports that officials are concerned about the latest development because Chiron, the world's fifth largest vaccine maker, is under contract to produce pilot supplies of human vaccines against bird flu, which has spread quickly in Asia.
Children were much more likely to suffer bad reactions to the Chiron vaccine than they were from an MMR vaccine made by another company.
Chiron reported that it plans to delay shipment of 50 million doses of its flu vaccine in the United States because of possible contamination. However, U.S. health officials said Friday that they don't expect it to be big problem, and that no shortage is expected.
Hospital Device Recalled After Children's Deaths
A probe used by hospitals to measure gas in patients' tissues has been recalled after the device was linked to several infections in critically ill children, three of whom died.
The recall, announced by the U.S. Food and Drug Administration Thursday, was undertaken voluntary by Nellcor Puritan Bennett Inc., the company that makes the CapnoProbe, after a cluster of infections with the bacterium Burkholderia cepacia came to light in intensive care units (ICU) at Children's Medical Center in Dallas, HealthDay reported Friday.
According to hospital officials, 13 children were infected out of a total of 115 children who had been exposed to one of the probes since December 2003. Eight of the 13 were still in their first month of life, and were in the ICU for other reasons. Three of the 13 children died, but it was not immediately clear whether the infections were the cause. B. cepacia is associated with the use of contaminated equipment and solutions and is known to strike people with weakened immune systems.
The FDA said in a statement that the infections were "life-threatening." But Dr. Jane Siegel, chairwoman of the infection control committee at Children's Medical Center, said Friday that most were not. Two of the infants died apparently because of their underlying disease, she said. In the case of the third infant, who was 16 days old, "it is possible that infection is a contributing factor," but not the sole cause, said Siegel.
The CapnoProbe, which measures the amount of carbon dioxide in tissue, won FDA approval in 2002, according to Randy Krotz, a spokesman for Tyco Healthcare, Nellcor's parent firm. According to the company, about 5,600 probes have been shipped since January 2003, and the device is used nationwide in about 60 health-care centers.
The investigation is continuing.
Vioxx Heart Risk Finding Re-Ignites Debate
A new study linking high doses of Vioxx to an increased risk of heart attacks and sudden cardiac deaths has re-ignited a running debate about the safety of the arthritis drug.
The FDA study of 40,500 people enrolled in Kaiser Permanente, the nation's largest health management organization, found that heart attack rates and sudden cardiac deaths were tripled in patients taking Vioxx in doses higher than 25 milligrams a day compared to those taking a competing drug, Celebrex, HealthDay reported Friday.
The FDA report said that "this and other studies cast serious doubt on the safety" of Vioxx and that Celebrex "may be safer."
Both drugs are members of a family called cox-2 inhibitors, designed to reduce the risk of gastrointestinal damage caused by other arthritis drugs. The previous studies cited in the FDA report, finding a higher risk of heart attack and similar problems in patients taking Vioxx, have caused other health insurers to place limits on its use.
"Vioxx is a non-preferred medication," said Amy Tulkington, a spokeswoman for the heath insurer Cigna HealthCare. "We cover it only for patients who cannot tolerate traditional medications. The decision on which drug to use is left to the physician."
Merck & Co., which markets Vioxx, "strongly disagrees" with the findings of the new study, according to a statement by Peter S. Kim, president of Merck Research Laboratories. He faulted the study as being merely observational, looking back at medical records, rather than a randomized, controlled clinical trial, "the gold standard to evaluate safety and efficacy."
U.S. Food Panel Urges More Whole Grains, More Exercise
More whole grains and more exercise for Americans are among the final recommendations issued Friday by an expert panel of scientists and doctors providing advice for the five-year update of the federal Food Pyramid.
The panel said that Americans should eat at least three one-ounce servings daily of whole grains in place of refined grains, or white bread, the Associated Press reported. Eating more whole grains helps people get more fiber, which has been shown to reduce the risk of heart disease and diabetes.
Increased exercise was another important recommendation. The panel said that in order to prevent weight gain, many people should do up to 60 minutes of moderate to vigorous physical activity each day.
These and other recommendations have to be approved by federal officials before they can be issued. An updated version of the food pyramid is expected to be released early next year.