Acetaminophen doses over 325 mg might lead to liver damage

You're in pain after surgery, and your doctor prescribes you Vicodin, or maybe Percocet. But when you get home, the pain hasn't subsided and you decide to pop some Extra Strength Tylenol.

Unknowingly, you may have just taken more of the drug acetaminophen than is safe.

Don't combine aspirin and ...

Acetaminophen is often used in pain medications with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine).

These are called combination drugs, and the Food and Drug Administration is asking doctors to stop prescribing those that have more than 325 mg of acetaminophen per dose.

FDA warns of acetaminophen liver damage FDA: Pain meds may cause liver damage

The FDA says no data show that taking more than that amount provides enough benefit to outweigh the risk of liver damage.

"Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much," the FDA said in a statement Tuesday.

The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. The FDA said it will address over-the-counter products in another regulatory action.

In 2011, the FDA asked manufacturers to limit the amount of acetaminophen in prescription combination drugs to 325 mg per capsule or tablet by January 2014. While more than half of the manufacturers agreed, some combination drugs with higher amounts of acetaminophen remain on the market. The federal agency says it plans to start the process of withdrawing approval of prescription combination drugs from manufacturers that have not complied.

Health risks

"Acetaminophen overdose is one of the most common poisonings worldwide," according to the National Institutes of Health.

Taking too much of this pain reliever can lead to liver failure or death.

The FDA has set the recommended maximum for adults at 4,000 milligrams per day. It's easier to reach this limit than you might think; one gel tablet of Extra Strength Tylenol, for example, contains 500 mg.

New Tylenol cap will have warning label

Consumers should not take more than the prescribed dose of any medication that contains acetaminophen, according to the FDA, and should avoid taking more than one acetaminophen product at a time. Drinking alcohol while taking acetaminophen also puts you at risk.

To find out if your medications contain acetaminophen, read the drug label or the list of ingredients in the patient information leaflet that came with your prescription. Look for the word "acetaminophen" or the letters "APAP," an abbreviation sometimes used for the drug. If you are still unsure, contact your doctor or pharmacist.

Acetaminophen may also cause serious skin reactions in some people. According to the FDA, the skin reactions are rare but can be deadly. These conditions can cause blisters, serious rashes, reddening of the skin and the detachment of the upper surface of the skin, the epidermis.

Anyone who develops these types of conditions after using acetaminophen should stop taking the product immediately and visit a doctor or emergency room. FDA issues warning about acetaminophen and skin reactions

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Source: CNN (Yan, 1/16)

Toyota to pay $1.1B in 'unintended acceleration' cases

LOS ANGELES — After years of litigation and probes, Toyota announced a $1.1 billion settlement Wednesday to resolve lawsuits alleging "unintended acceleration" in some Toyota and Lexus models.

Toyota recalled millions of vehicles in 2009 and 2010 related to charges that throttles could jam in the open position.

Toyota will create a fund for retrofitting 3.2 million Toyota and Lexus cars with technology that makes them easier to stop in a panic situation, as part of the settlement in a U.S. District Court case that sought class-action status. Owners of models that can't be retrofitted will receive cash payouts. And those who sold their vehicles in late 2009 and all of 2010 will be eligible for compensation due to lowered resale value due to the issue.

In all, the company says the agreement affects 16 million owners of vehicles with electronic throttle controls, whether or not they were part of the recalls.

Toyota maintains that the bulk of unintended acceleration cases were due to floor mats that slid underneath accelerators and became trapped — and not the result of electronic defects in the cars' engine computers.

"We felt we achieved our objective, to defend the safety of the product," says spokesman Mike Michels. That having been done, the settlement is "a business decision and we turn the page on a lot of this."

The settlement is expected to be approved Friday by U.S. District Court Judge James Selna.

"After two years of intense work, including deposing hundreds of engineers, poring over thousands of documents and examining millions of lines of software code, we are pleased that Toyota has agreed to a settlement that was both extraordinarily hard fought and is exceptionally far-reaching," says Steve Berman, co-lead counsel for plaintiffs in the cases.

At least one industry analyst says the settlement is proof that Toyota was culpable. "Automakers don't pay billions of dollars to get rid of litigation involving driver error," says Sean Kane of Safety Research & Strategies.

The settlement comes more than three years after the fatal crash of a Lexus that killed an off-duty California Highway Patrol officer and his family near San Diego erupted into a full-blown scandal for the automaker.

At first, Toyota answered the sudden acceleration charges by saying that floor mats could become trapped under acceleration pedals. Then later, Toyota announced a series of worldwide recalls involving millions of cars, including some for potentially defective accelerator assemblies.

Toyota executives appeared before congressional hearings and were questioned about the issue. The National Highway Traffic Safety Administration launched an engineering investigation that was never able to show any electronic bugs were the cause of unintended acceleration. But the agency never dropped the issue.

Last week, NHTSA levied a $17.35 million fine against Toyota — the maximum currently allowed for a single violation — for waiting too long to report the issue that led to just one of the series of recalls, involving the 2010 Lexus RX 350 and RX 450h crossover SUVs.

To settle the unintended acceleration cases, Toyota agreed to:

Install a brake-override system in non-hybrid vehicles that were subject to floor-mat entrapment recalls. The systems, which are now common in new Toyota and Lexus vehicles, cut power to the engine when they sense that the driver is trying to stop the vehicle as if in a panic, such as by repeatedly pushing the brake pedal. Toyota says its hybrids don't need the system.

Put $250 million into a fund for former owners who sold their cars between Sept. 1, 2009, and Dec. 31, 2010, or leased them during the period to compensate them for reduced value of their vehicles due to publicity around issues of Toyota's unintended acceleration. The actual amount that will go to any individual owner wasn't immediately disclosed. It may become more clear, says Berman spokesman Mark Firmani, after Friday's hearing.

Create a separate $250 million pool to compensate owners of non-hybrid cars that can't be retrofitted with the brake-override system. Toyota spokesman Michels says cars without the system are still safe because the brake-override system is "not a prevention or cure" for floor mats that can become trapped under pedals.

Establish a "customer care plan" for all 16 million affected Toyota customers to add another three to 10 years to the warranty period for parts that could be related to unintended acceleration.

Pay $30 million to issue grants for study of auto safety and enhanced driver education.

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Source: USA Today (Woodyard, 12/26)

5 Key Steps To Staying Safe In Winter Driving

1. Make sure you and your car are properly equipped before you leave.

Do a quick check of your vehicle before you hit the road. Make sure that your car has ample antifreeze, the windshield is clean and you have plenty of windshield washer fluid, the headlights are clean and in working order and the tires have tread and are properly inflated. Also, make sure to have your battery tested, to avoid being stranded in the cold with a car that won't start.

In addition to your vehicle's mechanical equipment, it's important to keep some extra items in the trunk or glove box in case of emergency. Equip your car with a flashlight and extra batteries, a first aid kit, warm clothes, and a blanket. Remember to have sunglasses in the car as well. Its amazing how many people drive in the winter without them. The glare of the sun off of snow and ice can be more intense in the winter than it is in the summer.

One last thing to remember, perhaps the most important of all: Your cell phone.

2. Slow down and drive smoothly.

This may seem like a no-brainer, but even if you're driving an SUV or a four-wheel-drive truck, you cannot safely do 80 mph during a snowstorm. Four-wheel-drive may help your vehicle get going in the slushy stuff, but it's of no use when you're trying to steer or safely stop on a slippery road surface.

It is also important to avoid abrupt acceleration, braking and turns. Doing so can cause your vehicle to lose traction and can launch you into an uncontrollable skid, leading to a collision.

Driving too quickly is the main cause of accidents in winter conditions. Just be patient and accept the fact that it is going to take longer to arrive at your destination.

3. Do not tailgate.

It is important to remember that it takes a much longer distance to stop your vehicle in the snow or ice due to the greatly reduced traction, even with just a light covering on the road. You may think that the driver in front of you doing 35 mph on the freeway is going too slow and needs a reminder in the form of you riding their bumper, but doing so is dangerous. Be patient and stay back until it's safe to pass.

Tailgating often leads to accidents, especially if you are driving in stop-and-go traffic. If the car in front of you stops abruptly and you are following too closely, you can reflexively slam on the brakes and end up sliding into it. The resulting accident may be no more than a fender-bender, but having to deal with it on a busy road in the snow is certainly something that you want to avoid, especially if other cars are sliding around as well. Many serious accident injuries come from a second impact from another car after a seemingly trivial collision.

4. Do not use cruise control.

For some, driving with cruise control has become almost second nature. Sure, it prevents you from getting leg fatigue, keeps you from unwittingly speeding and is great on long trips, but driving with it on in winter conditions can be unsafe. Thus, if cruise control has become a staple of your driving habits, make a conscious effort to ensure that you are not using it in winter weather.

Using cruise control in the snow, ice or even rain is dangerous because if your car hydroplanes or skids, it will accelerate and rapidly spin the wheels since it will be trying to maintain a constant speed. If this happens, it will be more likely that you lose control of your vehicle.

5. Pull over or stay home.

If at any point during your trip -- or before you even leave -- you feel that the weather is too bad to continue driving, simply stay put. If you're out on the road, find a safe spot to pull over and wait until the weather passes or calms to the point where you feel comfortable driving again. If you haven't left yet, stay home and off the roads.

Remember, there is no shame in making the logical decision to stay in when the conditions are bad. You may be late arriving to your destination, but arriving late in one piece is much better than the alternative. Your boss or significant other will understand.

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Source: Aol Autos (Zak, 12/21)

Safety Agency Widens Inquiry on Ford Floor Mats

The National Highway Traffic Safety Administration has intensified an investigation into whether 480,000 Ford, Lincoln and Mercury vehicles have floors designed so that floor mats – if not properly secured – are nudged forward to snag the gas pedal and possibly cause unintended acceleration.

In a report posted on the agency’s Web site over the weekend, the agency says its investigation covers 2008-10 Ford Fusions, Mercury Milans and Lincoln MKZ models.

The agency says it is aware of 52 complaints from drivers who said floor mats prevented the accelerator pedal from returning to idle. But no accidents were reported.

Consumers who complained to the agency often said the unintended acceleration typically occurred after the driver pushed hard on the accelerator, as when merging onto a highway. But when the driver eased off the gas, the engine speed didn’t decrease. Drivers solved the problem by shifting into neutral or turning the engine off.

It seems possible, the agency report said, that the design of the floor pan can lift an unsecured floor mat so that it reaches the gas pedal.

The report noted mechanics who checked vehicles after owners complained of the problem blamed unsecured floor mats.

Ford changed the design of the pedals early in the 2010 model year, government investigators found. And, the “elevated rates of pedal entrapment” were found in the 2008 -10 model years before that change was made.

The agency began investigating the issue in May 2010 after receiving three complaints.

In a letter to the agency dated Sept. 9, 2011, Ford’s global director of automotive safety, Steven M. Kenner, wrote that problems with the gas pedal could occur only if the floor mat was not properly secured.

It is not a serious issue because the driver can move the floor mat with a foot or by tapping the accelerator pedal, Mr. Kenner wrote. Consequently, he said, Ford does not see a safety defect or “unreasonable risk” to safety.

More than two years is an unusually long time for the agency to go from a “preliminary evaluation” to the engineering analysis now under way. A spokeswoman for the safety agency could not immediately be reached for comment.

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Source: The New York Times (Jensen, 12/17)

Bad to the bone: A medical horror story

FORTUNE -- On Nov. 16, 2011, Georgia Baddley, a 70-year-old woman living near Salt Lake City, received a shocking call from a special agent at the U.S. Department of Health and Human Services. The agent told her that the government had come across new information about her mother's death.

Baddley was speechless. Eight years before, her 83-year-old mother, Barbara Marcelino, had unexpectedly died during spine surgery. At the time, Baddley didn't question what had happened; surgery was always risky for a woman of that age. She was horrified when the agent told her that the surgeon had injected bone cement into her mother's spine and that the product -- which was not approved for that use -- may have played a role in her death.

The agent explained that the government had filed criminal charges against the maker of the cement, a company called Synthes, and four of its executives. After hanging up the phone, Baddley sat in stunned silence. "I was taken aback," she says. "I had no idea that anything like that had happened."

Most people have never heard of Synthes, a medical device maker headquartered in West Chester, Pa. But the company became part of one of the most recognizable names in health care in June when Johnson & Johnson (JNJ) completed the purchase of it for nearly $20 billion -- the largest acquisition in J&J's history. Market watchers cheered the deal, which will expand the company's stable of high-margin orthopedic products. J&J, which has endured a series of reputation-sullying recalls and lawsuits in recent years, specifically cited Synthes's "culture" and "values" as evidence of its appeal, even as former Synthes executives awaited sentencing on charges of grievous conduct.

In 2009 the U.S. attorney in Philadelphia accused the company of running illegal clinical trials -- essentially, experimenting on humans. Between 2002 and 2004, Synthes had tested a product called Norian XR, a cement that has a unique capacity to turn into bone when injected into the human skeleton. The Food and Drug Administration explicitly told Synthes not to promote Norian for certain spine surgeries, but the company pushed forward anyway. At least five patients who had Norian injected into their spines died on the operating-room table. One was Barbara Marcelino.

The indictment of Synthes and its executives shook the health care industry. What occurred is a classic example of corporate malfeasance, but set inside an insular corporation run by a reclusive and autocratic Swiss multibillionaire, the provider of the largest individual gift in the history of Harvard University. The case offers a rare, sometimes disturbing, glimpse inside the shrouded world of medical devices, where surgeons occasionally turn for advice during operations to twenty something sales representatives.

Most of all, this is a story about a company that repeatedly ignored evidence of potential lethal consequences. Interviews with more than 20 former employees and surgeons involved in the Norian project, hundreds of pages of court transcripts, and company documents submitted in the case reveal that Synthes not only disregarded multiple warnings that it was flouting the rules, but also brushed off scientists' cautions that the cement could cause fatal blood clots.VV The Department of Justice targeted four high-ranking executives, all of whom pleaded guilty to a misdemeanor under an unusual provision of health care law called the Responsible Corporate Officer Doctrine. They accepted responsibility for the company's crime of running unauthorized clinical trials and for engaging in off-label marketing, or promoting products for unapproved uses, without conceding that they were involved in the crime. At the time, no executive had ever gone to prison for such a charge.

(Lawyers for the four executives declined to make their clients available for interviews or to comment on the facts of the case.)

Off-label marketing is so common among drug and device makers that it's often dismissed as the equivalent of driving slightly over the speed limit. During the past decade, pharmaceutical behemoths such as Merck (MRK), Pfizer (PFE), Abbott Labs (ABT), and GlaxoSmithKline (GSK) have paid billions in fines to settle charges that they engaged in off-label drug promotion. Yet cases continue to happen, in part because the potential profits often exceed the fines.

But this wasn't the typical off-label marketing case. Nor was it typical of trials for medical devices or drugs. Patients sometimes die during such clinical trials -- but only after being advised of the risks and then granting their consent. In hiding the unapproved status of the cement, prosecutors argued, Synthes denied patients the right to choose whether they wanted to be test subjects.

For the Justice Department, the Synthes case posed an unprecedented opportunity. It could finally hold individual businessmen accountable for their actions. Mary Crawley, the assistant U.S. attorney who led the prosecution, urged the court to send the executives to jail for their "venal crime." The "callous disregard of patient safety," she argued, "warrants the highest sentence the law will allow."

Read the entire story at CNN’s website.

Ruling Raises Questions About List of Unsafe Consumer Products

Consumer groups said Tuesday that a federal court decision could threaten the effectiveness of saferproducts.gov, a relatively new federal database of unsafe products.

The ruling, by Judge Alexander Williams Jr. of United States District Court in Maryland, sided with a manufacturer who sued to keep its name out of the database, arguing that the complaint against it was confusing and contradictory and therefore should not be published.

The manufacturer, whose name and product remain anonymous, submitted medical data to the Consumer Product Safety Commission, which maintains the database, showing that the information in the database was “materially misleading.” The commission staff agreed, but the manufacturer argued that the corrected reports perpetuated the errors, and it filed a lawsuit.

Judge Williams, in a decision dated July 31 but made public on Monday, ruled that the safety commission’s decision to publish the complaint was “arbitrary and capricious” and that it could influence a consumer’s behavior, despite a disclaimer stating that the safety commission doesn’t endorse the findings.

On Tuesday, several consumer groups filed an appeal of the judge’s decision to keep some files sealed, as well as parts of the judge’s ruling. They also contested the judge’s decision to allow the manufacturer to proceed under the pseudonym “Company Doe.”

“The price that we pay for secrecy in cases like this is it can open the door to lots of litigants,” said Scott Michelman, an attorney for Public Citizen, one of the groups filing the appeal. “I do not expect this to be the last time that a company tries to keep a report of one of its products out of the database.”

In a prepared statement, the safety commission said, “The decision published yesterday concerning one incident reported to the saferproducts.gov consumer database does nothing to change the agency’s statutory mandate and enduring commitment to provide the public with a timely and searchable database of incidents involving consumer products. Consistent with the decision, the Commission did not post the individual report.” Judge Williams dismissed allegations that the decision would set off a flood of lawsuits by companies trying to stay off the database. “The prospect of successful challenges to the database does not threaten to categorically compromise the Commission’s consumer safety mission,” the judge wrote. “In sum, there is ample middle ground between the foundation this opinion lays and the apocalypse the Commission predicts.”

The database is the result of 2008 legislation that gave the safety commission more money and authority after numerous product recalls, including children’s toys from China.

The database, which went online in March, allows consumers, and others, to file complaints of injury, or potential harm, for all types of products except for food, drugs, cosmetics, cars and guns. More than 11,000 reports have been filed to the database so far. Before incident reports are posted, manufacturers are given a chance to respond, and if they can show that the entire report or part of it is not accurate, the report is supposed to be redacted or not posted on the database.

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Source: The New York Times (Martin, 10/24)

Is Texas ready for 85-mph speed limit?

LOCKHART, Texas — For drivers who feel the need for speed, Wednesday is a big day in Texas.

A new 40-mile stretch of Texas 130 toll road bypassing Austin's east side will open with an 85-mph speed limit -- highest in the United States.

"I think people will routinely pass me going 100. Regardless of the speed limit, there's always going to be people who want to go past it," said Jeff Gibeaux, a civil engineer in Lockhart who plans to take the high-speed road to Austin on occasion.

While most states have raised speed limits gradually in recent years, Texas is going at it full throttle.

Since 2002, the Texas Department of Transportation -- at the urging of state lawmakers -- has raised the speed limit to 75 or 80 mph on nearly 6,507 miles of road.

Most of the increases have occurred since 2011, when a new state law broadened which roads qualified for higher speeds.

The speeds are now posted not only in rural areas but also on major roads such as Interstate 20 and Interstate 35 just outside Dallas-Fort Worth and other major metro areas.

On about 1 in 12 miles of Texas roadway -- including interstates, small highways and farm-to-market roads -- motorists may now legally travel at speeds once considered excessive and dangerous.

Safety experts in the U.S. and Europe warn that fatalities and injury accidents are likely to rise. Texas' fatality rate is already higher than the national average, with 3,015 people killed on roads in 2011.

"You need to take measures to counteract an anticipated increase in deaths," said Veronique Feypell de la Beaumelle, an analyst with the International Transport Forum, which publishes a road safety annual report with crash data from the U.S. and 31 other countries.

But state officials say they don't necessarily expect more carnage. On the contrary, they point to statistics showing that fatalities are declining along some West Texas highways that were the first to get higher limits.

They say their methods of studying a road before raising a speed limit are scientifically sound, although they are applied differently in various parts of the state.

Less certain is whether motorists have the proper training, or the self-discipline, to drive safely on a high-speed road. State officials say they are developing ways to promote better driving habits.

Last week, the Transportation Department began installing 3,400 signs reading "Left lane for passing only" on highways with a speed limit of 75 mph or more. The same message was flashed on more than 700 electronic highway signs statewide.

"We're going to have to teach Texans how to drive these safer speeds," said Bill Meadows of Fort Worth, a Texas Transportation Commission member.

Meanwhile, as lawmakers encourage the Transportation Department to raise speed limits in one county after another, researchers at organizations such as the Insurance Institute for Highway Safety are taking issue with some of the state's guiding principles for determining when to raise a speed limit.

State officials have said they generally believe that motorists will drive at a comfortable speed, regardless of the posted limit, so it's important to set limits near the thresholds at which people are already traveling. But that philosophy can conflict with a belief held by critics who say drivers go whatever speed they think they can get away with and often exceed posted speeds because they perceive them to be conservative.

Economics are a factor, too.

The new section of Texas 130 toll road is being built by a private developer known as State Highway 130 Concession Co. Llc., which is led by the U.S. arm of Spain-based Cintra. Texas 130 is part of the Austin area's Central Texas Turnpike System. The developer is spending $1.4 billion on the project for the right to collect tolls through Nov. 11, 2062. To protect its investment, the group is paying Texas an extra $100 million in return for setting an 85-mph limit, according to the contract.

The idea is to attract more motorists to the road with the promise of higher speeds, which in turn generates more toll revenue.

Speed studies

State law requires the Transportation Department to perform a speed study before raising the limit on a stretch of road but lets the agency decide how to go about it.

Two of the agency's top safety officials demonstrated the process for the Star-Telegram this month on a stretch of Texas 130 that is already open north of Austin. There, the limit was raised to 80 mph this year, and the road could be a candidate for 85 mph in the near future, they said.

The first step in the speed study was for the pair of state employees to conduct a "trial run" of the 19-mile stretch. Darren McDaniel, a speed zone engineer for the department's Austin district, was given the task of driving the length of the road in a department pickup. Carol Rawson, director of the state's traffic operations division, sat in a passenger seat and took notes on McDaniel's speed.

McDaniel purposefully avoided looking at his speedometer and focused instead on driving at a speed he felt comfortable with -- most of the time, he was going 80 to 82 mph.

The two were helped in their work by a couple of gadgets installed in the truck: a digital instrument to help Rawson track the speed without having to continuously look at the dashboard and an inclinometer mounted on the dash that was programmed to sound an alarm if the truck took a curve with too much gravitational force.

The duo also took notes on factors such as visibility on the road and the amount of clear space available on the shoulders and in the median, in case a motorist has to take evasive action.

Texas highways are typically designed to accommodate speeds of at least 70 mph -- the state's default limit until a speed study can be conducted, six months or more after a road opens to the public.

But roads can be designed for higher or lower speeds.

For example, a small portion of the planned Chisholm Trail Parkway in southwest Fort Worth is being designed for 50 mph to ensure that traffic goes relatively slowly through some old neighborhoods.

And, as with the Texas 130 extension, roads can be designed to accommodate 85-mph limits from their first day open to traffic.

The next step in the speed study was taking a sample of at least 125 randomly selected cars to determine how fast people are traveling on the road -- typically known as an 85th percentile test.

McDaniel and Rawson parked their truck on an overpass in Pflugerville near Austin and, using a laser gun like what police use to issue traffic tickets, they determined that 85 percent of the vehicles on this stretch of Texas 130 were traveling 83 mph or less.

As a result, the road was a candidate for an 80- or 85-mph speed limit, they said.

The idea is to set a speed limit so that 85 percent of motorists are obeying the law. Rawson said it's a commonly accepted standard in traffic-engineering circles that 85 percent of drivers are traveling at a safe, comfortable speed -- regardless of the posted limit.

"Most people drive what's safe and prudent, because we know people aren't wanting to hurt themselves," she said.

"They're not wanting to get into a crash. Most importantly, they want to get where they're going, so generally they're going to drive a speed that's reasonable, and that's what we're looking for."

'A moving target'

A top official at the Insurance Institute for Highway Safety, a research organization that tracks collision data throughout the U.S., said placing so much weight on the 85th percentile standard is leading states such as Texas to raise speed limits beyond reasonable levels.

"The 85th percentile is a moving target," institute President Adrian Lund said. "People do pay attention to the speed limit: They use it as a guideline and figure out how much faster they can go without getting a ticket. Gradually, you end up with the same number of people exceeding the speed limit that you had before. There's an assumption that the government is always conservative, so if 85 is the speed limit, then 90 and 95 must be safe, right?"

Higher speed limits could hit Texans in the pocketbook, too. If accidents increase, the cost of auto insurance will go up, David Snyder, vice president of the American Insurance Association predicted in a 2011 column that ran in the Star-Telegram.

Texas' fatality rate is already higher than the national average, and Texans pay some of the highest insurance rates.

Lawmakers' mandate

In April 2011, a state House transportation committee approved a bill that gave the Transportation Department power to raise the speed limit to 75, 80 or 85 mph on thousands of miles of the highway system, as long as a speed study was conducted on at least one place in each segment of roadway.

The bill, which eventually became law, also eliminated lower speed limits for trucks and for all traffic at night.

The lone vote against the bill was from Rep. Yvonne Davis, D-Dallas.

"When you've got as many inexperienced drivers on our highways as we do, the last thing you want is people going 75, 80, 85 mph," Davis said this month in an interview. "I thought the whole notion of raising the speed limit that high was crazy."

The bill passed without comment, although Davis said it was clear in the Capitol hallways that the measure had plenty of support -- particularly among rural lawmakers who were hearing from constituents that they wanted to legally drive faster.

"It probably started with the rural representatives," Davis said. "But these speed limits are in urban centers, too."

Support for higher speeds tends to be particularly strong in cities that stand to benefit economically from the lure of traffic, although projects such as the Texas 130 extension can also brew controversy.

About 30 miles southeast of Austin, the new Texas 130 extension leads to Lockhart, a city of about 13,000 that is known for its barbecue joints.

Residents aren't too happy that the speed limit on the frontage roads of U.S. 183 running parallel to the Texas 130 extension has been lowered from 65 to 55 mph.

State officials have said the lower limit is needed because commercial development is springing up along the frontage roads, creating a safety issue for motorists pulling in and out of driveways.

But many residents say the real motivation is to force traffic onto the 85-mph toll road.

And on the toll road, there is little opposition to the 85-mph limit.

"We're thrilled about it," said Wendy Ramsey, owner of Wendy R Gift Shop on the town square. She regularly drives 80 mph on the portion of Texas 130 that's already open and, beginning Wednesday, she fully expects to drive 85 mph on the new part of the toll road.

"There's so few cars on 130 at this point," she said, "that right now it seems safe."

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Source: Star-Telegram (Dickson, 10/22)

FDA: More drugs may be linked to meningitis outbreak

Federal regulators broadened their warning to doctors Monday, raising questions about the potential risk of infection from other injectable drugs made by the specialty pharmacy in Massachusetts linked to the burgeoning fungal-meningitis outbreak.

The Food and Drug Administration initially said it received reports of three new cases of infections tied to two additional products made by the New England Compounding Center (NECC). It later corrected its statement, saying it had reports of two cases.

One involves the steroid triamcinolone acetonide, which is different from the steroid implicated in the existing meningitis cases. A patient who may now have meningitis received an epidural of the medication, the FDA said.

The other case involves a medication that is injected into the coronary arteries to temporarily paralyze the heart during open-heart and transplant surgery. Two patients who received the medication, called cardioplegic solution, during heart-transplant surgery, subsequently developed fungal infections, the agency said.

As a result of the cases, the sterility of any injectable drugs made by the NECC, including ones used in eye and heart surgery, “are of significant concern and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection,” the agency said in a statement posted on its Web site.

Steven Immergut, an FDA spokesman, said the agency didn’t know how many additional patients are affected and how many will need to be notified. The agency is working with the now-shuttered company to “get more information on the distribution of their products,” he said in an e-mail.

Until now, the meningitis infections have been linked to contaminated vials of one NECC steroid drug — methylprednisolone acetate. About 14,000 people received injections of that medication. As of Monday, 212 people have been received diagnoses of fungal meningitis linked to the tainted drug, two others have ankle infections and 15 have died, according to the Centers for Disease Control and Prevention.

The FDA has not confirmed that the two additional products were contaminated or that the three infections were caused by NECC products, according to its statement. The agency said it was possible there may be other explanations for the patients with fungal infections.

But the FDA said it is advising doctors to follow up with any patient who received “any injectable product” made by the NECC, including drugs used in eye surgery or cardioplegic solution bought from or produced by the company.

Doctors should inform patients who received the NECC products about symptoms of possible infection and tell them to contact a health-care provider immediately if they experience symptoms.

All of the company’s products have been under a voluntary recall by the company on Oct. 6. As part of that effort, the company attempted to contact all health-care providers and facilities that received its products, the FDA said. The agency had previously advised health-care providers and facilities to check their purchase records to see whether they bought any products from NECC and urged them not to use any products from the company.

In a statement issued Monday, the NECC said it was reviewing the FDA’s expanded advice to health-care practitioners. The company, which is a compounding pharmacy, said it was continuing to cooperate with officials from the FDA, the CDC and the Massachusetts pharmacy board.

“As we have said, we will respect those public agencies’ processes for investigations and will not comment while they are underway,” the company said.

Federal regulators said they are working with company officials to produce a specific list of injectable drugs that could be posted as soon as possible.

“A large portion of NECC’s products were injectables,” said the FDA’s Immergut. The company, which had a 71-page product list, makes more than 2,000 products, from pain medications such as fentanyl to such commonplace items as mouthwash to all-purpose nipple ointment to treat soreness and infection in nursing mothers.

The FDA said the company’s topical products, such as lotions, creams and eyedrops not used in surgery, pose lower risks and don’t require patient follow-up. The firm’s annual revenue is about $8 million, according to company spokesman Andrew Parven.

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Source: The Washington Post (Sun, 10/15)

When Non-Driving Factors Affect Auto Insurance Premiums

Automobile insurers may use factors unrelated to driving, like education and occupation, in determining rates.

Now, a consumer group is urging state insurance commissioners to restrict insurers’ ability to use those factors, arguing that the result has been unfairly high rates for lower-income drivers. Stephen Brobeck, executive director of the Consumer Federation of America, said in a call this week with reporters that premiums should mainly reflect factors like accidents, speeding tickets and miles driven.

The federation analyzed auto insurance premiums quoted on the Web sites of the five largest insurers (State Farm, Allstate, Geico, Progressive and Farmer’s) to price minimum liability coverage in five cities. Using an example of coverage for a 35-year-old woman with a good driving record, the study obtained quotes while varying characteristics like marital status, education level, occupation, home ownership and gaps in insurance coverage. Her driving record was the same in all instances.

The group found that in most cases, annual premiums were much lower if the woman was a married homeowner with a college degree, a professional job and continuous insurance coverage. In four of the examples, the premiums fell by at least 68 percent.

Premiums tended to be high if the woman was single, rented in a moderate-income area, had a high school degree, worked as a bank teller or clerical worker and had a gap in insurance coverage.

The analysis first obtained quotes for the “standard” example — a 35-year-old single bank teller with a high school degree and good credit record who rents a house in a moderate-income Zip code. The hypothetical woman had driven 15 years with no accidents or moving violations, and sought the minimum required liability coverage on a 2002 Honda Civic. Then, the researchers changed the criteria to see what the impact was on the quoted premium.

For instance, the “standard” quote of $2,696 from Progressive, for coverage in Baltimore, fell to $2,212 when the woman’s status was changed from single to married. And when all the criteria were changed to more a “favorable” status, the quote dropped to $718.

J. Robert Hunter, insurance director at the consumer federation, said a difference of nearly $2,000 based on non-driving factors is “patently unfair” and “actuarially unsound.”

Jeff Sibel, a spokesman for Progressive, said the insurer “works to price each driver’s policy as accurately as possible, so that every driver pays the appropriate amount based on his or her risk of having an accident.” He added: “To do this, we use many different rating factors, which sometimes include non-driving factors, that have been proven to be predictive of a person’s likelihood of being involved in a crash. Because different insurers use different information, which can cause rates to vary widely, we encourage consumers to shop around to find the combination of price and service that’s best for them.”

Alex Hageli, director of personal lines for the Property Casualty Insurers Association of America, disputed the federation’s position in an e-mail, saying that data have shown “consumers’ age, marital status, place of residence and occupation to be among the best predictors of future loss.” When such factors are “blended together” with criteria like driving experience, previous claims and vehicle age, he said, “these factors help to ensure that low-risk consumers can be better identified and pay less for insurance. In the final analysis, consumers benefit when insurance underwriting and rating decisions are based on a wide variety of fair and objective factors.”

Loretta Worters, spokeswoman for the Insurance Information Institute, an industry group, said in an e-mail, “What’s missing from the C.F.A.’s analysis is that every one of these factors that they attack is correlated, and highly correlated, with loss.”

Mr. Hunter of the consumer federation said his concern with using factors like occupation and education is that such factors are “surrogates” for criteria that states aren’t allowed to use in setting premiums, like income. At the very least, insurers should give less weight to non-driving factors in setting premiums, he said.

Los Angeles had the lowest quotes, he said, because California limits the use of non-driving factors in setting insurance rates. It is up to state insurance commissioners and legislatures to take action, he said, because auto insurance is regulated at the state level.

“We’re not trying to say get rid of these entirely,” he said. “We’re saying, you have to look at the combined effect and study these factors more carefully.”

Using non-driving factors drives up premiums, and forces many working families to drive without insurance, even though they risk paying fines or criminal charges for doing so. “Many low- and moderate-income citizens can’t afford required insurance because insurers use unfair rating factors,” he said.

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Source: The New York Times (Carrns, 9/28)