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Health Highlights: Aug. 27, 2004

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  • Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

    Contamination Will Delay Release of Flu Shots

    A major maker of influenza vaccines for the United States market said it has found that some of its new supplies are contaminated, delaying release of some 50 million doses, the New York Times reported Friday.

    Chiron Corp. makes about half of the 100 million doses slated to be used this flu season, the newspaper account said. Except for a small amount that was sent to distributors in July, the company won't begin shipping the vaccine until mid-October, about a month later than planned, its CEO told the Times.

    The disclosure came on the heels of this week's revelation that the Bush administration had devised a plan on how to respond to a theoretical flu pandemic.

    Chiron produces its flu vaccine at a plant in Liverpool, England. CEO Howard Pien would only tell the newspaper that the contamination was biological in nature and may have been caused by human error. The problem involved eight of 60 batches tested so far, he said.

    The company was to make about 25 percent more vaccine than it produced last season. A second manufacturer, Aventis Pasteur, said it was ahead of schedule in making more than 50 million doses. A third company, MedImmune Inc., told the newspaper it planned to make up to 2 million doses of FluMist, an inhaled spray vaccine.

    The director of the U.S. Centers for Disease Control and Prevention, Dr. Julie Gerberding, acknowledged that Chiron's announcement could delay inoculations for a month or more, but added that she didn't "anticipate an overall shortage."

    As a result, she said, the CDC had no immediate plans to change its recommendations for who should get the vaccine. It is most recommended for the elderly, younger children, and others with respiratory problems that may make them more susceptible to the virus.

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    Hospital Device Tied to Deadly Infections in Children

    A hospital device used to measure carbon dioxide levels in patient tissues is being recalled after investigations revealed that the device probably caused life-threatening infections among 11 children at a Dallas hospital, the U.S. Food and Drug Administration said.

    Two children died following use of the probe, produced by Nellcor Puritan Bennett, a unit of Tyco Healthcare. Company and federal investigations into what caused the deaths are ongoing, the FDA said in a statement.

    The children were found to be infected with Burkholderia cepacia bacteria, which is often associated with intensive care patients on whom contaminated equipment is used. Eight of the infected children at Children's Medical Center had been part of a company research study into the probe's effectiveness on children. The device -- produced at Nellcor's Tijuana, Mexico, plant -- is also used on adults.

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    Vioxx, in Certain Doses, Triples Heart Attack Risk

    A study conducted by the U.S. Food and Drug Administration on prescription pain relievers has determined that one of them, Vioxx, triples a person's chances of having a heart attack in higher doses. To compound the problem for Vioxx's manufacturer, Merck & Co., the FDA found that the drug's major competitor, Celebrex, may be safer.

    According to the Associated Press, the fallout from the study, which was presented Wednesday at a conference in France, could be that health maintenance organizations would reconsider at what strength Vioxx should be prescribed.

    Vioxx and Pfizer Inc.'s Celebrex belong to a class of pain relievers known as cyclooxygenase-2 (cox-2) inhibitors. Their primary advantage in treating painful ailments such as arthritis is that they don't irritate the stomach as many over-the-counter medications do.

    According to the AP, the study was conducted on 40,405 Kaiser Permanente patients who took Celebrex and 26,748 who took Vioxx.

    The results found that heart attack rates tripled for patients taking Vioxx in doses higher than 25 milligrams per day.

    Merck defended its drug. In a statement, Peter S. Kim of the company's research laboratories said, "Based on all of the data that are available from our clinical trials, Merck stands behind the efficacy and safety, including cardiovascular safety, of Vioxx."

    But, according to the wire service, the FDA researchers concluded that "this and other studies cast serious doubt on the safety" of high doses of Vioxx.

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    Drug Giant to Release Trial Results on Web

    GlaxoSmithKline agreed on Thursday to post the results of all clinical trials of its drugs, both positive and negative, on the Internet.

    The agreement is part of a settlement the British drug giant entered into with New York State Attorney General Eliot Spitzer, who said that it would change drug industry practices, the New York Times reported.

    The action involved only Glaxo, but Spitzer predicted that other drug companies would follow. If not, he said, he would file more lawsuits. Several other drug companies, such as Eli Lilly and Johnson & Johnson, said they support a change.

    Spitzer sued the company in June, accusing Glaxo of committing fraud by publicizing the results of only one of five trials on the effects of Paxil, its blockbuster antidepressant, on children. That study had mixed results, the Times reported, while the rest either showed no benefit or found that children who use the drug may become more suicidal.

    The trial results will appear on Glaxo's Web site.

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    2nd Judge Strikes Down New Abortion Law

    A second federal judge has found the Partial-Birth Abortion Ban Act unconstitutional, this time because the law does not include an exception to protect the mother's health.

    Thursday's ruling in Manhattan by U.S. District Judge Richard Casey said the U.S. Supreme Court has stipulated that any law limiting a woman's right to abortion must include a health exception, according to an account by the Associated Press.

    A San Francisco judge has already declared the November 2003 law illegal, and a third judge in Lincoln, Neb., is considering the question but has yet to rule.

    The law bans a procedure that foes call partial-birth abortion, in which a later-term fetus is partially removed from the womb and its skull punctured. The law represents the first substantial federal legislation to limit a woman's right to abortion since the U.S. Supreme Court's historic 1973 Roe v. Wade ruling declared abortion legal.

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    Are Doughnuts Proper Rewards for 'A' Students?

    Krispy Kreme plans to award students a doughnut for every 'A' on their report card, but critics say the company's plan runs counter to a program to get children to eat healthier foods.

    The company will give up to a half-dozen doughnuts per marking period, the Palm Beach Post reported.

    But the reward comes soon after the Robert Wood Johnson Foundation, the country's largest philanthropic group, and others invested $1.4 million to promote healthier lifestyles among students in Florida's Palm Beach and Broward Counties, the paper said.

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