The group that certifies medical labs' virus identification skills said Saturday it will state more clearly what to include in test kits, aiming to avoid another scare like the one when samples of a dangerous flu strain were sent to labs worldwide.
"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," said Dr. Jared Schwartz of the American College of Pathologists, which ordered the kits from Meridian Bioscience Inc. of Newtown, Ohio.
The pathologists group also will check with the Centers for Disease Control and Prevention to make sure the agency considers all test viruses low-risk, Schwartz said Saturday.
The comments came after a week of reports of Meridian's inadvertent distribution of H2N2, a strain also called the "Asian flu," to 4,700 laboratories. A lethal form of that virus triggered a 1957 pandemic that killed up to 4 million people.
Schwartz said Meridian officials told him Friday they hadn't determined how the mix-up occurred but were looking into labeling procedures between it and the company that supplied the virus to Meridian.
Meridian CEO William Motto, reached at home Saturday, said the company's only comment would come in a news release. Meridian's Web site had no statement Saturday on the flu sample mix-up.
Experts Warn on Expense of U.S. Drugs
About 130 million Americans swallow, inject, inhale, infuse, spray, and pat on prescribed medication every month, the U.S. Centers for Disease Control and Prevention indicates. Americans buy much more medicine per person than any other country.
The number of prescriptions has swelled by two-thirds over the past decade to 3.5 billion yearly, according to IMS Health, a pharmaceutical consulting company. Americans devour even more nonprescription drugs, polling suggests.
Recently, safety questions have beset some depression and anti-inflammatory drugs, pushing pain relievers Vioxx and -- most recently —- Bextra from the market. Rising ranks of doctors, researchers and public health experts are saying that America is overmedicating itself. It is buying and taking far too much medicine, too readily and carelessly, for its own health and wealth, they say.
Actor James Garner Heads Up New Lupus Campaign
Actor James Garner, whose daughter has lupus, is alerting women to the risks and dangers of this common but poorly understood illness in a new campaign.
The "Get into the Loop" campaign features a 30-second television ad that explains how lupus can start with seemingly minor problems such as fatigue, fever and joint pain but can lead to more serious complications, even death.
In the ad, Garner says: "Lupus has scarred my youngest daughter's life. Protect yourself. Get the facts. Get into the Loop."
Lupus is a chronic autoimmune disorder that causes the body's immune system to attack its own healthy tissues and organs. Affecting about 1.5 million Americans, lupus strikes most between the ages of 15 and 44. Women account for 90 percent of lupus patients.
A recent report in the New England Journal of Medicine found lupus to be directly responsible for plaque build-up in arteries that can lead to heart attack and stroke, and about 50 percent of lupus patients develop related kidney disease that can potentially result in kidney failure, requiring dialysis or kidney transplant.
The "Get into the Loop" campaign is a project of the Lupus Research Institute, the National Kidney Foundation and WomenHeart: the National Coalition for Women With Heart Disease.
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. It is requesting that Pfizer provide in its response details on how it will make "truthful, non-misleading and complete" corrections to its ads.
Two-Thirds of Flu Virus Specimens Destroyed
Two-thirds of deadly flu virus shipments mistakenly sent to labs throughout the world have been destroyed, officials at the U.N.'s World Health Organization said Friday. The agency said it is still tracking down two shipments bound for Lebanon and Mexico, according to the Associated Press.
The agency estimates that thousands of labs in 18 countries received samples of the 50-year-old H2N2 virus as part of a flu test kit, and a global effort has been underway to identify and destroy those samples. As of Friday, WHO influenza chief Klaus Stohr said 10 countries have confirmed that they have destroyed their specimens. However, labs in Lebanon and Mexico "never received the specimen 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.
According to the WHO official, Hong Kong, Belgium, Singapore, Canada, Chile, France, Germany, Italy, South Korea and Taiwan have now confirmed that their labs have destroyed their samples of the virus.
Five other countries -- Saudia Arabia, Bermuda, Brazil, Israel and Japan -- received the kits as well. Sohr told the AP Saudi Arabia has tracked down and destroyed samples in four out of five labs, while the four other countries have not yet confirmed they have destroyed their pathogens, although they have received instructions to do so.
It is still unclear whether all the shipments to U.S. labs, which received the bulk of the specimen kits, have been destroyed.
Speaking with the Cincinnati Post, Dr. Jared N. Schwartz, secretary-general of the American College of Pathologists, said his organization shipped 3,747 of the test kits, including a total of 9,181 specimens of the H2N2 virus, between September and early April. By Thursday afternoon, the ACP had received confirmation that 2,227 of the kits in labs worldwide have already been destroyed.
How kits including the deadly virus managed to get shipped at all remains a mystery, Schwartz told the Post. He speculated that a labeling error at Meridian Bioscience, a Newtown, Ohio company charged with preparing the test kits, might be to blame. But Schwartz said that idea is purely conjecture since Meridian officials have remained silent on their role, if any, in the H2N2 debacle. "There is not good communication at this point," Schwartz said.
Another group, 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. He told the Post that, as of Thursday morning, 303 of these kits had been destroyed.
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, but only if customers have another way to get a prescription filled, CNN said.
The network, citing statistics from the reproductive-rights group NARAL Pro-Choice America, said at least 10 states are considering legislation allowing pharmacists to refuse to fill birth control prescriptions. A federal law would pre-empt any state law.