Health Highlights: April 16, 2005
Flu Virus Scare Spurs Test Kit Changes Report: Schiavo Was Not Abused FDA Tells Makers to Pull Ads for Levitra, Zyrtec U.S. Bill Would Ensure Prescriptions Are Filled
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Flu Virus Scare Spurs Test Kit Changes
The group responsible for certifying the quality of medical labs' virus-identification methods said Saturday it is revising its requirements for pathogen-containing laboratory "test kits" in the wake of this week's frightening flu virus debacle.
Dr. Jared Schwartz, of the American College of Pathologists (ACP) -- which sent out over 3,700 of the kits to labs across the U.S. -- said it will state more clearly which types of pathogens are to be included in all test kits it uses from now on.
"Instead of saying, 'We want influenza A or influenza B' or whatever it is we want, we're going to be more specific, down to a subtype level," Schwartz told the Associated Press.
Health officials announced Wednesday that strains of the highly virulent H2NS "Asian flu" virus were mistakenly sent to thousands of labs worldwide as part of routine quality-control test kits.
However, a Canadian lab discovered the kits contained the H2N2 variant, isolated from a 1957 outbreak that killed up to 4 million people around the world. Overall, experts estimate that 4,700 of the tainted kits were sent to laboratories in 18 countries, with most destined for labs in the U.S.
As reported by the AP, officials at the U.N. World Health Organization (WHO) announced Friday they expected that labs in 15 countries will have completely destroyed all of their suspect samples by Saturday.
WHO influenza chief Klaus Stohr said 10 countries -- Hong Kong, Belgium, Singapore, Canada, Chile, France, Germany, Italy, South Korea and Taiwan -- have now confirmed that their labs have destroyed all samples of the virus, while five other countries -- Saudia Arabia, Bermuda, Brazil, Israel and Japan -- are in the process of tracking down and destroying their samples.
Labs in two countries -- Lebanon and Mexico -- "never received the specimens even though they were on the distribution list," Stohr said. It's possible those samples were never shipped, Stohr added, and the WHO is launching an investigation into these missing kits.
Schwartz said the ACP shipped 3,747 of the test kits, including a total of 9,181 specimens of the H2N2 virus, to labs in the U.S. between September and early April. By Thursday afternoon, the ACP had received confirmation that 2,227 of the kits had already been destroyed. Schwartz told the AP that destruction of the U.S. samples was taking longer due to the higher volume.
How kits including the deadly virus managed to get shipped at all remains a mystery, The ACP ordered the test kits from a supplier, Meridian Bioscience, of Newtown, Ohio. According to Schwartz, Meridian officials told him Friday that they had not yet gotten to the bottom of the mix-up, but were investigating labeling procedures existing between themselves and a second company, which supplied Meridian with the virus.
Reached at home on Saturday, Meridian CEO William Motto told the AP the company's only comment would come later in a press release.
Another professional organization, the American Association of Bioanalysts, in St. Louis, Mo., also sent out a total of 343 H2N2-tainted kits, according to AAB administrator Mark Birenbaum. Speaking with the Cincinnati Post, Birenbaum said that, as of Thursday morning, 303 of these kits had been destroyed.
Health officials at both the WHO and the U.S. Centers for Disease Control and Prevention (CDC) have said there are no reports of infection linked to the samples, and that risks to the public remain low.
Report: Schiavo Was Not Abused
Florida state investigators have found no evidence of abuse, neglect or denial of needed care in the case of Terri Schiavo, according to a report in Saturday's New York Times.
Schiavo, who doctors say was in a vegetative state since suffering a heart attack 15 years ago, became the center of an intense right-to-die debate as her husband Michael battled with her parents to have her feeding tube removed. The courts agreed with his request, and Schiavo died on March 31.
Documents released Friday show that Florida's Department of Children and Families completed nine reports of abuse accusations made from 2001 to 2004, including neglect of hygiene, denial of dental care, poisoning and physical harm. All of the accusations were targeted at Michael Schiavo.
No evidence of abuse or neglect were found in any of the reports, which Judge George W. Greer, of Pinellas-Pasco Circuit Court -- who has presided over the Schiavo dispute -- has ordered released to the public before Monday.
According to the Times, the names of many of the accusers have been blacked out in the reports, although the name of Terri Schiavo's father, Robert Schindler, does appear in one.
FDA Tells Makers to Pull Ads for Levitra, Zyrtec
U.S. Food and Drug Administration officials are demanding that a specific television ad for the anti-impotence drug Levitra and three direct-mail ads for the allergy medicine Zyrtec be pulled due to what the agency called unsubstantiated claims.
According to the Associated Press, the 15-second Levitra spot features a woman extolling the benefits of the drug on her and her partner's sex life. She calls Levitra "the best way to experience the difference," but the FDA called this an unprovable claim. The agency also said the drug's maker, Bayer Pharmaceuticals Corp., fails to cite FDA warnings and other important product information in the ad.
The three Zyrtec direct-mail ads compare two individuals: one obviously sick and congested, and another healthy. Captions in the ad imply that the healthy-looking person has taken Zyrtec, but the FDA said that "it is not aware of substantial evidence or substantial clinical experience demonstrating that Zyrtec is clinically superior" to other over-the-counter or prescription allergy drugs.
The agency is asking that both companies pull the ads and respond in writing to the FDA's request.
Matthew Scampoli is a spokesman for Schering Plough, which markets Levitra for Bayer. He told the AP that the 15-second spot is one in a three-commercial campaign, and that the other two will continue to run. However, he said, "We are going to comply with the FDA's request" to pull the third ad.
The FDA had harsher words for Pfizer, noting that this was the fourth such warning it had given the company regarding Zyrtec ads.
U.S. Bill Would Ensure Prescriptions Are Filled
Both houses of Congress have crafted legislation designed to ensure that all legal drug prescriptions are filled, even if a pharmacist cites moral beliefs that equate certain forms of birth control with abortion.
The legislation, dubbed the Access to Legal Pharmaceuticals Act (ALPhA), would allow pharmacists to refuse to fill a prescription only if it could be filled by a co-worker at the same pharmacy, CNN reported.
"Nobody has a right to come between any person and their doctor," the network quoted the legislation's Senate co-sponsor, Sen. Frank Lautenberg (D-NJ), as saying. "Today they might not fill prescriptions for birth control pills. Tomorrow it could be painkillers for a cancer patient," he added.
The American Pharmacists Association favors the idea of letting pharmacists follow their conscience.