UPI NewsTrack Health and Science News

GAO: FDA shirks device-approval mandate

WASHINGTON, Jan. 15 (UPI) -- A U.S. health agency does only minimal testing before approving high-tech medical devices, despite an order to do full reviews, a federal report said Thursday.

Most of these complex devices such as pace makers and replacement heart valves receive quick approvals with minimal testing because manufacturers tell the U.S. Food and Drug Administration the products operate just like older devices already approved, the Government Accountability Office report said.

"So on the one hand, the manufacturer wheels in their new Ferrari to the FDA and says, 'Look, it's a car just like the Model T,'" Memorial Sloan-Kettering Cancer Center Dr. Peter Bach told The New York Times.

"Then they go out in the marketplace and say to doctors, 'Why would you drive anything but a Ferrari?' This drives up the cost of care without any necessary actual improvement in outcomes," Bach said.

The GAO -- Congress' audit, evaluation and investigative arm -- recommended the FDA fulfill promises it made 14 years ago to fix its system for approving complex medical devices.

In 1995, the FDA promised Congress it would come up with rules for testing such devices, but never followed through, the GAO said.

The FDA had no immediate comment.

Mars methane suggests life underground

WASHINGTON, Jan. 15 (UPI) -- Huge methane gas bursts on Mars appear to be caused by bacteria rather than volcanic activity, U.S. government scientists said Thursday.

The researchers at NASA's Goddard Space Flight Center in Greenbelt, Md., did not say what bacteria created the methane, the principal component of natural gas.

But their findings, published in the journal Science, suggest the possibility of present-day microbes living on the fourth planet from the sun, The New York Times reported.

On Earth, bacteria known as methanogens produce methane as a metabolic byproduct, the newspaper said.

These bacteria are common in wetlands, where they are responsible for marsh gas, as well as in hot springs and at hydrothermal vents at the bottoms of oceans.

In most environments, the release of methane is the final step in the decomposition of biomass, scientists say.

The National Aeronautics and Space Administration researchers said it was unlikely the methane came from hot springs or hydrothermal vents because Mars shows no signs of recent volcanism or hot spots.

So they said they're focusing on bacteria as the methane source.

The scientists said mineralogy of Mars's surface indicated the bedrock might be covering gas-rich materials, suggesting biological life may exist underground.

Study: Tasers not fatal heart attack risk

WINSTON-SALEM, N.C., Jan. 15 (UPI) -- Taser stun devices police use to subdue fleeing, belligerent or dangerous suspects play no role in fatal heart attacks, a U.S. university study says.

The three-year study by Wake Forest University's medical school found no links between the 50,000-volt weapons and fatal heart attacks, the researchers said in the Annals of Emergency Medicine, published by the American College of Emergency Physicians.

The devices manufactured by Taser International Inc. are carried by more than two-thirds of U.S. police agencies. Tasers are controversial because some people hit by their electroshock projectiles were injured or died.

"We finally have a real-world estimate of the risk associated with these weapons ... and we found that to be low," study author Dr. William Bozeman said.

"That's important because these are violent encounters, and a small scrape or bruise is simply not the same as serious head injury or life-threatening internal injury," he told the Orlando (Fla.) Sentinel.

Researchers from five medical schools reviewed 1,201 shock-arrest cases and tied three serious injuries and no deaths to the devices, the researchers said.

They attributed the two deaths to a combination of prolonged struggles, drug abuse and preexisting medical conditions.

Amnesty International said last month Taser shocks "caused or contributed to at least 50 deaths" in the United States between June 2001 and August 2008.

Coroners attributed most of those deaths to other causes, such as drug intoxication or "excited delirium," the human rights groups said. It defined "excited delirium" as "a term often used to describe someone who is in an agitated or highly disturbed state."

Advocates to sue over gray wolf de-listing

WASHINGTON, Jan. 15 (UPI) -- U.S. Endangered Species Act advocates say they will sue the Interior Department to stop its plan to remove the gray wolf from the endangered species list.

The department said that starting March 1 it would lift Endangered Species Act protection for the wolf, also known as the timber wolf, in Montana and Idaho, parts of Oregon, Utah and Washington, and in the western Great Lakes.

It did not include Wyoming because the state has not done enough to assure the animal's survival, the department said.

Defenders of Wildlife, which lobbies and uses the legal system in the hope of protecting endangered and threatened species, said it would sue the department.

Its president, Rodger Schlickeisen, called the department's decision "a blatantly political maneuver."

"States have plans to kill hundreds of wolves as soon as they're de-listed," he said.

The Center for Biological Diversity, which also advocates for endangered species, said it may also take the matter to court, online newspaper eFluxMedia reported.

The Bush administration has tried to de-list the wolf three times. But judges have reversed those decisions in response to lawsuits brought by environmentalists, who argued wolf populations were not fully recovered.

The rule is scheduled to be published Jan. 27 and to take effect 30 days later.