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2010 June Archive

Unhappy Happy Meals

A consumer group has issued an ultimatum to McDonald’s, according to www.consumeraffairs.com – do away with the Happy Meals or else. The Washington D.C.-based nonprofit, Center for Science in the Public Interest (CSPI), has promised it will file a class action complaint against McDonald’s because providing toys with unhealthy food to encourage children to eat unhealthy food is illegal under consumer protection statutes in California, Texas, Massachusetts, the District of Columbia, and New Jersey. CSPI may have got a little overboard when it compared McDonald’s to a child molester.

“McDonald’s is the stranger in the playground handing out candy to children,” says CSPI attorney Stephen Gardner.

In response, McDonalds says it is committed to a responsible approach to its menu and is offering more healthy choice options than ever before. Many parents may succumb to an occasional McDonald’s out of convenience and children’s choice, so this approach has the potential to backfire.

Ever since 1979, McDonald’s has offered the toy as part of the Happy Meal. Often it partnered with Disney to co-promote the latest movie, however, Disney ended that relationship in 2006, perhaps because of the increasing focus on childhood obesity.

This is not the only time McDonald’s has faced litigation over its food. The American Heart Association sued and settled with McDonald’s over the amount of trans fats in its food. The settlement reached in 2005, amounted to $7 million with another $1.5 million for an advertising campaign to inform the public about the dangers of trans fats. After that, McDonald’s began cooking its fries without trans fat oils.

At the end of the day this is no joke. Twenty-three years ago, the Centers for Disease Control and Prevention found that no states had an obesity rate of more than 14%.

Today, there are only four states with obesity rates less than 20%.

In the South, the obesity rate averages 27%. That means almost one out of three people are obese. This is not sustainable and it can be slowed beginning with our children.


FDA Expands Regulation over Big Tobacco

Because the Food and Drug Administration’s Tobacco Control Act is one year old, it now has expanded powers. The Act was approved by Congress to keep kids from smoking and to help adults kick the habit. The FDA cannot regulate nicotine or outright ban smoking – a public health problem that kills 400,000 Americans every year – but it can chip away at Big Tobacco and its marketing intended to encourage young people to start smoking.

Big Tobacco knows if it can hook young people before the age of 19 that they are likely to become lifelong smokers.

It’s now against the law to sell cigarettes to anyone under the age of 18. Sales cannot be for anything less than a full pack of cigarettes. There can be no tobacco-sponsored events whether sporting or music.

One major tobacco consumer information point of concern is that the Tobacco Control Act now bans the industry from putting a positive spin on tobacco products and prohibited advertising or labeling tobacco products as “light”, “mild”, or “low”, and their promises of a lessened risk.

More and larger health warnings are going on smokeless tobacco packages.

Cigarette manufacturers will not be allowed to make or distribute flavored cigarettes such as fruit, spice, and candy-flavored, obviously aimed at hooking new smokers and they will not be allowed to market them to adolescent and teen smokers.

Part of the FDA’s expanded regulatory powers force cigarette makers to become more transparent, listing all ingredients, including toxins, added to tobacco.

Ironically, it is a user fee on tobacco manufacturers that is now funding the FDA crackdown on the industry.


FDA Warning About Magic Power Coffee

The Food and Drug Administration (FDA) wants consumers to stop using Magic Power Coffee which is purchased online and promises to be a dietary supplement for sexual enhancement. In reality, it contains some of the active ingredients present in Viagra, which is available by prescription only.

The FDA analyzed the coffee and found it contains hydroxythiohomosildenafil, which is similar to sildenafil, the active ingredient in Viagra. It may interact with prescription drugs known as nitrates. And FDA spokesman, Ira Allen, says that the amount of drug in the coffee far exceeds its prescription cousin.

The product is made in China and imported to the U.S. by a company called INZ / Magic Power Coffee Inc. Brooklyn, NY. When the FDA asked the company to issue a recall and stop importing Magic Power Coffee, they refused. This highlights the insufficiency of the agency at this time. The FDA cannot force a recall unless it first goes to court and obtains an order that allows the agency to confiscate product and sue the company. That move is being considered.

For users, a sudden drop in blood pressure can lead to dizziness or lightheadedness as the brain is deprived of adequate blood supply. The company calls this an “all natural dietary supplement” which means nothing. The FDA does not regulate dietary supplements. Despite the warning, the FDA admits there have been no adverse reactions reported in connection with Magic Power Coffee.

The Internet is full of marketing for dietary supplements that promise to enhance your sexuality. Many include undeclared ingredients or compounds that in no way qualify as “dietary ingredients”. The product is distributed through multi-level marketing and is sold in a two serving box and 12-serving carton. If you do experience any adverse or negative side effects you can report them to the FDA’s MedWatch program at 1-800-FDA-1088 or go online at www.fda.gov/medwatch/report.htm.


Ford Recall in China

This is a story that is not getting a lot of play in the U.S. but it is big news in China. Based on an article from The Epoch Times, the Ford Motor Company is recalling over 236,643 Focus sedan cars in China.

The problem is with the Ford Focus models made between August 2008 and May 28, 2010. About two percent of drivers had problems with the ignition that causes the vehicles to stall, especially at low speeds. The “fix” involves putting in new engine calibration software.

This is the second recall so far this year for Ford of Dearborn, Michigan. 17,600 vehicles were recalled in February for faulty breaking in its hybrid vehicles. This Focus recall is the largest so far for Ford in China.
These Ford Focus vehicles were made by a three-way joint venture comprised of Ford, Chongqing Changan Automobile and the Mazda Motor Corp of Japan. Changan owns 50% of the company. Ford owns a 35% stake, and Mazda the remaining 15% stake. Expect to see more cars produced for the Chinese market including the Ford Fiesta and the Ford Mondeo.

Just last March, the Changan plant produced its 500,000th Ford Focus, which has become a best seller in China with yearly sales rising 55 percent from a year earlier.

The new Ford Focus, a 1.8 liter, four-door sedan, is set to begin production in Europe and North America.


Shrek Glass Recall Began with Tipster

According to www.npr.org, McDonald’s has been caught in an embarrassing moment. Instead of checking the composition of the Shrek glasses it is selling for $2 to consumers and presumably children, all part of a tie-in to the new Shrek movie, a tipster has let the company know that the glasses contain the toxic metal cadmium.

The Consumer Product Safety Commission (CPSC) has recalled 12 million of the glasses even though the agency says they do not pose an “acute” risk. The levels of the toxic metal are just slightly above the standard that’s under consideration by the agency, which does not currently have a standard for safety.

An anonymous tipster contacted the office of Rep. Jackie Speier from California after he or she tested the glasses. They, by the way, are not made in China, but by ARC International in Millville, New Jersey.
Why does our children’s health have to rely on an anonymous tipster? Parents have been buying the “Shrek Forever After” that coordinates with the May 21 release of the movie.

The glasses are 16-oz and feature Shrek, Fiona, Puss n’ Boots, and Donkey. Cadmium can soften bones and cause severe kidney problems after long-term exposure. If you have purchased one of these toxic glasses be sure to go on the McDonald’s Web site and see how to return them for a full refund.

You’ll remember that another retailer that targets children, Claire’s, had a similar problem with cadmium-clad jewelry it was selling to adolescents. Why these giant companies that make their fortunes off the whims of children cannot take the extra step to ensure the products they are selling are safe is a mystery, and a defective product liability issue.


Medical Community Responds to Prescription Drug Abuse

It’s almost become a daily occurrence. A celebrity dies from a drug overdose and teens pop pills like they exchange cigarettes. Prescription pill abuse has become commonplace with an estimated seven million Americans abusing prescription drugs. That is more than the numbers of people abusing illegal drugs such as heroin and cocaine.

Part of the reason is availability. According to a report, the use of psychotherapeutic drugs, such as antidepressants, grew 84 percent from 1999 to 2004.

Clinical guidelines published in the Journal of Pain find that one in four Americans has chronic pain. The use of prescription painkillers grew more than 300 percent between 1995 and 2005.

Now the American Pain Society is urging random urine drug screening to confirm that patients are taking prescription drugs as they have been prescribed. A toxicology services company, University Services, finds that among more than 350,000 cases, about 61 percent are not following their prescriptions.

Besides contributing to 3.8 billion in lost work hours each year, patients who do work may not really be all there. Many are unaware of unanticipated side effects which can include an overdose from mixing drugs, compromised workplace safety and suicides.

Clinicians say doing a urine drug screening finds not just drugs that people are on but drugs they are supposed to take but are not taking. The issue of monitoring drug use will be discussed next month in Chicago at an annual Pain and Substance Abuse Forum.


Children Choking on Hot Dogs

As incredible as it sounds, a central Florida student from East Ridge Middle School in Lake County died after choking on a hot dog at school on Friday, June 4. EMS workers arrived in the cafeteria and were able to establish some airway, but he later died at the hospital. We wonder if there was anyone certified in CPR or the Heimlich maneuver at the school to help the poor student. Our deepest sympathy goes out to his grieving family.

This is not dissimilar to another situation involving 23-month old Allison Hale. She was eating from a microwave bag of popcorn when a kernel became lodged in her throat and she stopped breathing. Then her heart stopped beating. The autopsy showed she inhaled popcorn into a lung, her bronchial tubes, and her vocal cords.

Now the American Academy of Pediatrics (AAP) is calling on the Food and Drug Administration (FDA) to require a warning label on food that can present a choking hazard – not unlike what is already required for toys that are dangerous.

The hot dog is a leading hazard, as are grapes and candy, and the AAP would like manufacturers to redesign the food. The National Hot Dog and Sausage Council tells the New York Times that the redesign is not going to happen. Already there is a hot dog on the market that breaks apart when eaten.

Children under the age of 4 are most susceptible to the dangers of choking on dangerous foods. It’s best to wait until they are five or older to introduce the foods. Estimates are that about 160 children died from food obstructions in 2000. Most parents say the same thing, “I can’t believe this happened, I was standing right there.”

The Heimlich maneuver can be performed on a child older than one year, but if the child is younger, face them down on your knee and slap the area between the shoulder blades five times. Be sure you’ve already called 911.


Xenical, Alli Warning Added to Label Over Liver Injury

The Food and Drug Administration is toughening up the label on the popular weight-loss drug, Alli, also sold by prescription as Xenical. The new label will include a warning about the possibility of liver injury. Xenical is made by Roche Holding AG while Alli is an over-the-counter lower-dose version of the same drug marketed by GlaxoSmithKline PLC (GSK). The active ingredient in both drugs is orlistat.

The FDA has received 12 reports of liver injury associated with Xenical from outside the U.S. and one report associated with Alli. Among those reports, two people died and three needed a liver transplant. Experts say that is a small number considering that an estimated 40 million people worldwide have used Xenical or Alli.
Roche said the company would continue to monitor Xenical’s safety profile and share that information with health regulators.

GSK says the updated label on Alli will tell consumers to stop using the drug and seek medical help if they “develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.” Combining orlistat with other drugs may also lead to serious liver injury.

The FDA says that at this time, a cause-and-effect relationship has not been established. However, because of the seriousness of the liver injuries, the warning is being added to educate the public about the signs and symptoms of liver injury.


Consumer Advisory to Owners of 2010 Ford Fusion and Mercury Milan

The National Highway Traffic Safety Administration is warning owners of the 2-1- Ford Fusion and Mercury Milan about the dangers that come from placing unsecured floor mats on top of the standard mats or carpets in the floor. NHTSA is launching a formal investigation into allegations that the pedals may become entrapped in the depressed position after three consumer complaints concerning the MY 2010 Fusion.

The problem may be that Ford’s optional rubber “All Weather “ mat, when laid on top of the secured, standard carpet on the floor of the driver’s side can slip forward and land on top, trapping the accelerator pedal. That causes the pedal to remain in the depressed position and causes unintended acceleration. It is most likely to occur after the driver has accelerated such as when merging or passing traffic. So far the NHTSA has received no reports of crashes, injuries or fatalities. Ford says the original floor mats have special attachments to secure them to the car’s floor on the driver’s side. Make sure they are properly installed and restrained with the retention hooks to the floorboards. Drivers of all makes and models need to make sure that any driver-side floor mat is safety secured and follows the manufacturer’s instructions for installing the mats.

In case your car lurches out of control, NHTSA suggests the following:

  • Brake firmly and steadily – do not pump the brake pedal.
  • Shift the transmission into Neutral (familiarize yourself with where Neutral is).
  • Steer to a safe location.
  • Shut the engine off.
  • Call your dealer or repair shop to pick up the vehicle. Do not drive it.

Dennis Quaid Files Lawsuit Over Drug Mix-UP

Actor Dennis Quaid and his wife have filed a lawsuit against drug maker, Baxter Healthcare Corp., for a drug mix-up that almost killed their newborn twins in 2007. The twins, Zoe Grace and Thomas Boone, were given the blood thinner, Heparin, instead of the lower dose, Hep-lock. Both drugs are made by Baxter and have similar packaging and are in similar vials with a blue background and small print on the labels.

According to a Contra Costa Times article, the twins received near fatal doses of Heparin to treat a staph infection – 10,000 units of Heparin rather than the 10 units of Hep-Lock they were supposed to receive, says the complaint. The babies began bleeding out at Cedars-Sinai Medical Center with blood coming from every orifice and that’s how their parents found them when they entered the room. They suffered internal injuries and shock, but appear to have recovered, though the complaint says the extent of long-term injuries will not be known for years.

The complaint, filed Friday, May 21, in Los Angeles Superior Court, says that Baxter Healthcare should have recalled the vials and fixed the labeling problem after other infants had died from similar medication errors. After those deaths, Baxter understood that the same-looking vials and labels could cause confusion, yet the drugs remained on hospital shelves.

Newborns are often given Hep-Lock to flush their intravenous lines instead of Heparin.

There is no dollar amount specified in the lawsuit. Deerfield Illinois-based Baxter Healthcare Corp. is a unit of Baxter International Inc.

Florida Heparin lawyers realize that this case is not just about blaming Baxter, but about holding drug companies accountable for their mistakes and encouraging them to make the safest drugs complete with clear labels possible. Baxter tried to have the lawsuit that was filed in Illinois dismissed in 2008 with the argument that drugs and their labels are approved by the federal government. That argument went nowhere but the action in Illinois was dismissed on jurisdictional grounds in 2008.

The Quaids sued Cedars-Sinai Medical Center and reportedly signed off on a $750,000 settlement with the hospital without it admitting any wrongdoing.

The twins’ overdose is an example of the estimated 100,000 fatalities stemming from medical errors that occur every year in American hospitals and from pharmaceuticals.