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Health Highlights: June 25, 2005

Changes to Mad Cow Test After 2nd Case Confirmed Patient Deaths Spur 'Enclosed Bed' Recall Experts: U.S. Flu Pandemic Could Kill 500,000 House Passes Bill Barring Medicare Viagra Coverage Guidant Issues Alert on 5 Defibrillator Models

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

Changes to Mad Cow Test After 2nd Case Confirmed

U.S. Department of Agriculture Secretary Mike Johanns announced major changes to the nation's "mad cow" testing protocols at a news conference late Friday. The announcement comes after an internationally respected British testing lab confirmed the second-ever case of the disease in a U.S. animal -- even though some prior USDA tests suggested the cow did not have the illness.

In keeping with testing guidelines in place at the time, the animal tested positive for mad cow, or bovine spongiform encephalopathy (BSE), on two faster "Elisa" tests and a slower (unspecified) "experimental" test, Johanns said.

But the animal also tested negative on a slower immunohistochemistry test, which until yesterday was considered the U.S. "gold standard," the New York Times reported.

Faced with these contradictory results, the Agriculture Department sent samples to the English laboratory, widely regarded as one of the world's best. That lab confirmed that the animal did have BSE.

The cow, slaughtered in November, was born before the 1997 U.S. ban on feeding ruminant protein to ruminant animals, Johanns said. It was considered a "downer" that was unable to walk and had not entered the human food supply, he added.

"This animal was blocked from entering the food supply because of the firewalls we have in place. Americans have every reason to continue to be confident in the safety of our beef," he told reporters.

But Johanns also listed other errors in the agency's testing process. The animal's brain samples were frozen, making testing more difficult; parts from five carcasses were mixed together; and no written records were kept, he said.

Critics had harsh words for the USDA's handling of the case. "The Agriculture Department should've gotten it right in the first place," Rep. Henry A. Waxman, D-Calif., told the New York Times. "The administration's response to mad cow disease appears to be more public relations than public health."

Johanns said that there was no evidence the animal was born outside the country, and added that DNA tests are currently underway to determine its herd of origin.

Meanwhile, Taiwan on Saturday reimposed an immediate ban on imports of American beef after the second case was confirmed.

Two months ago the island lifted a ban it had imposed in February 2004 following the discovery in 2003 of the disease in a Washington state cow that had been imported from Canada. The origin of the new case wasn't immediately made available.

BSE occurs when proteins called prions bend into misfolded shapes. They deposit plaque that kills brain cells and leaves behind spongy holes. People who eat contaminated meat may acquire a human form called variant Creutzfeldt-Jakob disease, which has killed about 150 people worldwide, the AP said.


Patient Deaths Spur 'Enclosed Bed' Recall

The FDA announced Friday a manufacturer-initiated recall of over 5,000 "enclosed," zippered and canopied bed systems after 30 incidents of patients becoming entrapped between the bed's side-rail and mattress or between the canopy and mattress.

Patients in 8 of those incidents died as a result of entrapment and asphyxiation, the FDA said in a statement.

The beds, made by Vail Products, Inc., of Toledo, Ohio, are meant to be used as an alternative to sedation or physical restraint in patients with cognitive impairment or uncontrolled behavior, seizures or spasms.

Vail Products is sending out new instruction manuals to every customer warning them of the hazard and informing them of the FDA's advice "to stop using the bed system, move patients to alternative bed systems if possible and consult with their physician." According to the FDA, Vail Products stated it has ceased making enclosed bed systems as of June 16th.


Experts: U.S. Flu Pandemic Could Kill 500,000

More than half a million people would die and 2.3 million would be hospitalized if a moderately severe strain of avian "bird" flu swept through the United States, a research group said Friday.

Experts at the Trust for America's Health based their estimates on a 25-percent infection rate, with those infected having no immunity against the virus. They estimate the pandemic would be less lethal than the great flu epidemic of 1918, but more deadly than the pandemic of 1968.

As reported by the Associated Press, the Trust called on lawmakers to set aside more than the $58 million already earmarked for anti-influenza measures. They especially urge the purchase of 70 million doses of Tamiflu, which may offer some protection to Americans as scientists race to develop a more effective vaccine.

Responding to the report, Senate Majority Leader Bill Frist, R-Tenn, agreed the United States was "woefully underprepared to respond in the event of a pandemic outbreak."


House Passes Bill Barring Medicare Viagra Coverage

Legislation barring Medicare or Medicaid coverage of erectile dysfunction drugs like Viagra was approved by the U.S. House of Representatives by a vote of 285-121 on Friday.

The amendment by Rep. Steve King (R-Iowa) is projected to save taxpayers $105 million next year, he told the Associated Press. A study he commissioned concluded that the federal government was projected to spend more than $2 billion over the next decade on the drugs.

"We don't force taxpayers to pay for face lifts, weight-loss drugs, hair-growth treatment or vacations, so we should not force them to pay for sexual-performance drugs," King was quoted by the wire service as saying.

The provision was added to pending legislation that barred the government from paying for the drugs for convicted sex offenders. Rep. Nancy Johnson (R-Conn.), an opponent of King's measure, had argued that law-abiding men who had lost sexual function due to illness shouldn't be denied the drugs.

The Senate has yet to consider the measure.


Guidant Issues Alert on 5 Defibrillator Models

Five models of Guidant Corp.'s implantable cardiac defibrillators have a faulty switch that could cause a malfunction and doctors should stop using these models until further notice, the company said Friday.

The five models are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF. Guidant said about 46,000 of these models are in use, the Associated Press reported.

There have been at least four confirmed malfunctions in these devices, and a fifth suspected case. No patients have been injured.

This is the second safety advisory issued this week for defibrillators made by Indianapolis-based Guidant, the AP reported. The company recalled 50,000 implantable ones after reports of 45 failures that resulted in at least two deaths.


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