Archive for the ‘Safety’ Category

AAA poll finds pets may pose road risks

Safety experts have a new pet peeve related to distracted driving.

In addition to texting or talking on a cell phone while driving, lap dogs and other pets left unrestrained inside moving vehicles pose a major distraction that could be deadly, a study released Wednesday warns.

About two-thirds of dog owners surveyed by the AAA organization said they routinely drive while petting or playing with their dogs, sometimes even giving them food or water while maneuvering through traffic.

It’s frisky behavior for the driver and dangerous for the pets too.

An 80-pound dog unrestrained during a crash at 30 mph exerts 2,400 pounds of force in a vehicle, creating a danger for the dog and anyone in its path, according to Motivation Design LLC, a company that manufactures pet travel products, including restraint systems for pets.

Fifty-five percent of 1,000 dog-owning drivers polled by AAA said they have pet their dog while driving, and 21 percent said they held the dog in their lap. Seven percent said they have given food and water to their dog while driving, and 5 percent said they have played with their dog while behind the steering wheel.

While 80 percent of poll respondents said they take their dogs on a variety of car trips, only 17 percent said they use a pet-restraint system to limit distractions and protect their pet.

“As about 40 percent of Americans own dogs, we see this as an increasingly big problem,” said Beth Mosher, spokeswoman for AAA of Illinois, Indiana and Wisconsin.

Many Toyota wrecks may be the result of footwork

Government investigators and Toyota Motor Corporation have reportedly found that driver error, not sudden unintended acceleration, may have caused dozens, of accidents involving Toyota vehicles.

The Wall Street Journal reported last week that a federal analysis of data from dozens of crashes blamed on sudden acceleration suggested that some drivers who lost control of their vehicles were mistakenly flooring the accelerator when they intended to hit the brakes.

Thousands of cases of unintended acceleration are being investigated by the National Highway Traffic Safety Administration, in conjunction with NASA.

Toyota Motor Corporation spokesman Mike Michels said “virtually all” of 2,000 cases of reported unintended acceleration the automaker has reviewed resulted from drivers stepping on the gas pedal instead of the brake.

NHTSA has received 3,000 reports of sudden acceleration in Toyota and Lexus automobiles, and Toyota has recalled 8.5 million vehicles worldwide to alter gas pedals that might stick or remove floor mats that in some cases have trapped gas pedals and made if impossible for drivers, to stop.

Toyota said that its investigations into the accidents have determined “a number of explanations or causes,” but insisted that “in no case have we found electronic throttle controls to be a cause.”

Study used to support diabetes drug Avandia is denounced in FDA review

A federal drug official dealt a severe blow Friday to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events.

Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Marciniak wrote.

The detailed report could prove crucial next week, when a panel of experts meets to consider whether to recommend to the FDA that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale.

The panel’s decision will have broad consequences for the company, the FDA and perhaps even the entire process by which medical products are approved. The agency rarely does clinical trials on its own, depending on drug companies to conduct them appropriately.

Avandia, which helps patients get better control of their blood sugar levels, has already come under intense criticism. It has been shown to increase the risks of bone fractures and to cause swelling that can lead to heart failure and eye problems. And a number of studies, including some by GlaxoSmithKline, suggest that it could increase the risks of heart attack, stroke, and death.

GlaxoSmithKline has relied heavily on the major clinical trial, named Record, to demonstrate that those risks are exaggerated.

Marciniak’s review of the Record study calls that assertion into question. He found one case in which a seizure patient was hospitalized for bleeding in the brain, but all mention of the episode was deleted from records. Another patient was hospitalized for 67 days after a severe stroke, but the study record showed no sign of a cardiovascular problem.

Another patient died after being hospitalized for a serious heart problem, but the death was listed as arising from an unknown cause and not as being heart-related.

Correctly interpreted, he concluded, the study actually supports critics’ contentions that Avandia may cause heart attacks and strokes.

“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes, heart attacks.

Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said, “The Record study was conducted according to good clinical practices, and the data are reliable.”

Marciniak’s review is part of a reassessment of Avandia’s safety by FDA medical officers to educate the panel meeting Tuesday and Wednesday.
Debate about Avandia’s safety and how to handle reports of its dangers has split the food and drug agency and led to fierce recriminations, staff departures and questions from Congress.

It was the FDA’s delay in issuing stronger warnings about Avandia that led Congress in 2007 to give the agency greater powers over drug makers.

Within the FDA, some officials insist that the evidence is mixed and others say it is strong enough to merit the drug’s withdrawal. An advisory meeting in 2007 concluded that Avandia did increase heart attack risks but that it should stay on the market.

Although endocrinologists have advised against its use, Avandia remains popular with nearly 2 million prescriptions last year. If the drug were to be withdrawn, GlaxoSmithKline — already facing lawsuits claiming Avandia caused injuries — would likely see its liability soar.

(Except of course, in Texas, where pain and suffering is capped at $250,000)

Legislators try to put brakes on red-light cameras

Public support for the use of red-light cameras in Texas and across the country could be switching from green to yellow.

Three states —Maine, Mississippi and Montana —banned red-light cameras last year, according to the National Conference of State Legislatures. Six others have considered similar proposals.

In Texas, voters forced College Station to take down its cameras last fall, and opponents in Houston say they have enough petition signatures to put the cameras to a vote this fall. Camera opponents in the Texas Legislature say they plan again to try to pass a measure phasing out the cameras statewide.

“There is a backlash, for sure,” state Rep. Solomon Ortiz Jr., D-Corpus Christi, who, co-sponsored the anti-camera push, told The Dallas Morning News. “City budgeters are counting on these fines as a revenue stream and simply using the argument of safety as cover.”

But cities using the camera systems, which capture images and sometimes video of drivers running red lights, insist they have reduced intersection accidents and saved lives.

“They’ve performed much better than I ever imagined,” said Elizabeth Ramirez, chief traffic engineer for Dallas.

She said Dallas has seen declines in red-light accidents at nearly every one of its 59 camera-equipped intersections since the first wave launched in January 2007.

With most Texas cities charging civil fines of $75 to $100 per violation, collections across the state have reached more than $103 million since a revised red-light camera law took effect in 2007. State figures show Houston has collected the largest amount: about $24 million through May.

A 2007 state law requires cities to set aside half of all profits to help fund regional trauma care centers. Most cities use their share for traffic safety, and enforcement efforts.

An analysis of state figures arid the vendor agreements of about a dozen Texas cities shows the contracts cities have with camera vendors are the biggest factor in whether a city makes money. Cities rent the cameras from vendors under negotiated terms.

Houston’s $24 million in collections since 2007 is more than triple the total fines collected by Dallas, according to figures from the state comptroller’s office. And in the past two years, Dallas’ program has cost more to run than Houston’s.

Paul Kubosh, a Houston traffic attorney who has led the Houston petition drive to repeal the cameras, accuses the city of “selling the streets to the highest bidder. It’s a voter revolt.”

Source: Austin American-Statesman

Study shows why people run yellow lights

Drivers know that green means go, red means stop and yellow often means “Can I make it?” Although the law is clear that yellow means slow down and prepare to stop, many drivers do not. New research sheds light on what factors come into play when a driver decides to run those yellows, and it turns out it’s not just a matter of speed.

Researchers from the University of Cincinnati, funded by the Ohio Department of Transportation, monitored four intersections in suburban areas of Ohio, using video cameras to track more than 1,500 drivers.

They found that cars traveling in right-hand lanes tended to go through yellow lights, while those on the left did not. Truckers also tended to
speed through yellows, as did drivers on streets with higher posted speed limits.

Not surprisingly, how long the light remains yellow also matters. (Yellow-light times vary but typically last about three to five, seconds. Traffic engineers base the time on the average speed of the vehicles passing through the intersection.)

The longer the yellow persists, the more likely it is that drivers will not stop, said Zhixia Li, an engineering doctoral student who worked on the study with his professor, Heng Wei.

In fact, Li said, with a long yellow, “stopping is more dangerous,” because other drivers are likely to keep going through the yellow, and someone who opts to stop runs a greater risk of getting hit from behind.

Study Show Avandia Creates Higher Risks

A new study led by a federal drug safety expert ties the diabetes drug Avandia to a higher risk of heart problems, strokes and deaths in older adults and says it is more dangerous than a rival drug, Actos.

The study, a huge review of Medicare records, comes two weeks ahead of a Food and Drug Administration hearing on Avandia’s safety.

The lead author, Dr. David Graham, is an FDA scientist who wants the pill banned.

As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, Graham said.

Study shows older people driving more but crashing less

Experts predicted crash rates would soar as Americans grew older.  However, older people are driving more but crashing less, and their fatal accident rate has dropped 37 percent.

The biggest drop of all 47 percent — came among drivers over age 80, according to a study released this week by the Insurance Institute for Highway Safety, an insurance industry group whose research uses both federal highway statistics and data collected by the companies whose policies cover the cost of accidents.

Though the numbers made the trend between the mid-1990s and early 2000s clear, they didn’t provide a solid explanation for the striking difference between what was anticipated and what happened.

Neither could the experts who compiled the statistics.

The same things that have factored in an overall decline in highway deaths — safer vehicles, more seat belt use and fewer drunken drivers — applied to those 70 and above, but there had to be more to the change.

The researchers compared the numbers for older drivers with a control group between ages 35 and 54, a range selected because those drivers have graduated froth the time of risky behavior and haven’t yet reached, the onset of age related impairments.

The older drivers did farbetter than the control group. The drop in fatal accidents among the 70 and older crowd was 14 percent steeper, and the decline in nonfatal crashes was 11 percent lower.

US. agency looking into reports of trapped pedals in Ford cars

Federal safety regulators are investigating a few reports of gas pedals becoming trapped by floor mats in 2010 Ford Fusions and Mercury Milans.

Officials with the National Highway Traffic Safety Administration said Tuesday that the agency opened a preliminary investigation last Friday after receiving three such complaints involving unsecured all-weather floor mats. There are no reports of crashes or injuries. Safety officials said the investigation covers about 250,000 Fusions and Milans.

A Ford spokesman, Said Deep, said the problem was attributable to drivers stacking all-weather mats on top of floor mats that come with the vehicle. Ford’s all-weather mats have warnings advising customers not to stack them and to secure them properly to the floor, Deep said.

Company behind recalls of kids’ drugs may face criminal penalties

The Johnson & Johnson unit that recalled millions of bottles of liquid children’s Tylenol and other pediatric medicines last month may face criminal penalties, product seizures or other sanctions, an official from the Food and Drug Administration said last Thursday.

The agency is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson unit, said Dr. Joshua M. Sharfstein, the FDA’s principal deputy comissioner, at a congressional hearing Thursday.

On April 30, McNeil voluntarily recalled more than 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec because they may have contained too much of the active ingredient of the drug, metal specks or inactive ingredients that failed testing requirements, the agency said. But McNeil’s problems go beyond those related to last month’s recall, including other forms of contamination, dating back two years.

Sharfstein noted lengthy delays by the company in reporting problems to the agency. And in one case, in 2008, he said, McNeil hired a contractor to quietly remove packages of Motrin from retailers for suspected quality problems — which he suggested was essentially an unannounced recall that was not reported to the FDA.

Sharfstein said the FDA was “considering additional enforcement actions against the company for its pattern of noncompliance. which may include seizures, injunction or criminal penalties.”

“I have become deeply concerned about your company,” Rep. Edolphus Towns, chairman of House Committee on Oversight and Government Reform, told the Johnson &. Johnson executive who testified. “It paints a picture of a company that is deceptive, dishonest and that has risked the health of many of our citizens.”

The Medical Malpractice Myth

Here’s a great article about how tort reform is unlikely to cut health care costs.

Here’s some of the article:

The health economists and independent legal experts who study the issue, however, don’t believe that’s true. They say that malpractice liability costs are a small fraction of the spiraling costs of the U.S. health care system, and that the medical errors that malpractice liability tries to prevent are themselves a huge cost– both to the injured patients and to the health care system as a whole.

“It’s really just a distraction,” said Tom Baker, a professor at the University of Pennsylvania Law School and author of “The Medical Malpractice Myth.” “If you were to eliminate medical malpractice liability, even forgetting the negative consequences that would have for safety, accountability, and responsiveness, maybe we’d be talking about 1.5 percent of health care costs. So we’re not talking about real money. It’s small relative to the out-of-control cost of health care.”

Insurance costs about $50-$60 billion a year, Baker estimates. As for what’s often called “defensive medicine,” “there’s really no good study that’s been able to put a number on that,” said Baker.

Contrary to Rick Perry’s claims, a recent analysis by Atul Gawande in the New Yorker found that while Texas tort reforms led to a cap on pain-and-suffering awards at two hundred and fifty thousand dollars, which led to a dramatic decline in lawsuits, McAllen, Texas is one of the most expensive health care markets in the country. In 2006, “Medicare spent fifteen thousand dollars per person enrolled in McAllen, he finds, which is almost twice the national average — although the average town resident earns only $12,000 a year. “Medicare spends three thousand dollars more per person here than the average person earns.”

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