News in June 2006

The Food and Drug Administration says an antibiotic made by Sanofi-Aventis will carry a new warning on its label about possible liver problems associated with its use.

The label for the drug Ketek will warn consumers of reports of liver failure and severe injury associated with its use.

Ketek was approved for use in 2004. Doctors prescribe it to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia.

Ketek is the first FDA-approved antibiotic of the ketolide class. The drug has been associated with rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant after the administration of the drug.

Although it is difficult to determine the exact frequency of Ketek-associated adverse events on the basis of FDA's mandatory and voluntary reporting systems, the agency said it has concluded that the drugs' benefit to patients for the approved indications outweighs its risk, including the rare risk of liver failure, and supports its continued availability.

"We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems," said Dr. Steven Galson, Director for FDA's Center for Drug Evaluation and Research.

"Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function." The signs and symptoms of liver failure include fatigue, malaise, loss of appetite, nausea, yellow skin and dark-colored urine.

The warning, which Ketek's manufacturer is adding to the drug's labeling, results from reports gathered by FDA's adverse event monitoring system, which follows drugs after their market introduction.

The agency said the monitor system received some reports of serious liver problems in patients taking Ketek, including some cases of acute liver failure leading to death or requiring liver transplantation.

FDA said it will continue to evaluate Ketek-associated safety issues and take further actions if warranted.

Three years after the preliminary results first were presented at a scientific meeting and drew wide attention, University of Utah psychologists have published a study showing that motorists who talk on both handheld and hands-free cell phones are as impaired as drunken drivers.

"We found that people are as impaired when they drive and talk on a cell phone as they are when they drive intoxicated at the legal blood-alcohol limit" of 0.08 percent, which is the minimum level that defines illegal drunken driving in most U.S. states, says study co-author Frank Drews, an assistant professor of psychology.

"If legislators really want to address driver distraction, then they should consider outlawing cell phone use while driving."

Psychology Professor David Strayer, the study's lead author, adds: "Just like you put yourself and other people at risk when you drive drunk, you put yourself and others at risk when you use a cell phone and drive. The level of impairment is very similar."

"Clearly the safest course of action is to not use a cell phone while driving," concludes the study by Strayer, Drews and Dennis Crouch, a research associate professor of pharmacology and toxicology. The study was set for publication June 29 in the summer 2006 issue of Human Factors: The Journal of the Human Factors and Ergonomics Society.

The study reinforced earlier research by Strayer and Drews showing that hands-free cell phones are just as distracting as handheld cell phones because the conversation itself not just manipulation of a handheld phone distracts drivers from road conditions.

Human Factors Editor Nancy J. Cooke praised the study.

"Although we all have our suspicions about the dangers of cell phone use while driving, human factors research on driver safety helps us move beyond mere suspicions to scientific observations of driver behavior," she said.

The study first gained public notice after Strayer presented preliminary results in July 2003 in Park City, Utah, during the Second International Driving Symposium on Human Factors in Driver Assessment, Training and Vehicle Design. It took until now for the study to be completed, undergo review by other researchers and finally be published.

Different Driving Styles, Similar Impairment

Each of the study's 40 participants "drove" a PatrolSim driving simulator four times: once each while undistracted, using a handheld cell phone, using a hands-free cell phone and while intoxicated to the 0.08 percent blood-alcohol level after drinking vodka and orange juice. Participants followed a simulated pace car that braked intermittently.

Both handheld and hands-free cell phones impaired driving, with no significant difference in the degree of impairment.

That "calls into question driving regulations that prohibited handheld cell phones and permit hands-free cell phones," the researchers write.

The study found that compared with undistracted drivers:

• Motorists who talked on either handheld or hands-free cell phones drove slightly slower, were 9 percent slower to hit the brakes, displayed 24 percent more variation in following distance as their attention switched between driving and conversing, were 19 percent slower to resume normal speed after braking and were more likely to crash. Three study participants rear-ended the pace car. All were talking on cell phones. None were drunk.

• Drivers drunk at the 0.08 percent blood-alcohol level drove a bit more slowly than both undistracted drivers and drivers using cell phones, yet more aggressively. They followed the pace car more closely, were twice as likely to brake only four seconds before a collision would have occurred, and hit their brakes with 23 percent more force.

"Neither accident rates, nor reaction times to vehicles braking in front of the participant, nor recovery of lost speed following braking differed significantly" from undistracted drivers, the researchers write.

"Impairments associated with using a cell phone while driving can be as profound as those associated with driving while drunk," they conclude.

Are Drunken Drivers Less Accident-Prone?

Drews says the lack of accidents among the study's drunken drivers was surprising. He and Strayer speculate that because simulated drives were conducted during mornings, participants who got drunk were well-rested and in the "up" phase of intoxication.

In reality, 80 percent of all fatal alcohol-related accidents occur between 6 p.m. and 6 a.m. when drunken drivers tend to be fatigued. Average blood-alcohol levels in those accidents are twice 0.08 percent. Forty percent of the roughly 42,000 annual U.S. traffic fatalities involve alcohol.

While none of the study's intoxicated drivers crashed, their hard, late braking is "predictive of increased accident rates over the long run," the researchers wrote.

One statistical analysis of the new and previous Utah studies showed cell phone users were 5.36 times more likely to get in an accident than undistracted drivers. Other studies have shown the risk is about the same as for drivers with a 0.08 blood-alcohol level.

Strayer says he expects criticism "suggesting that we are trivializing drunken-driving impairment, but it is anything but the case. We don't think people should drive while drunk, nor should they talk on their cell phone while driving."

Drews says he and Strayer compared the impairment of motorists using cell phones to drivers with a 0.08 percent blood-alcohol level because they wanted to determine if the risk of driving while phoning was comparable to the drunken driving risk considered unacceptable.

"This study does not mean people should start driving drunk," says Drews. "It means that driving while talking on a cell phone is as bad as or maybe worse than driving drunk, which is completely unacceptable and cannot be tolerated by society."

In the battle over Americas expanding waistline, much of the emphasis is on diet and exercise. A new study suggests other potential causes, including too much air conditioning, should be studied as well.

The report, published in the International Journal of Obesity, said researchers found no link between obesity and the proximity of children to fast food restaurants. On the other hand, researchers cite biology to link the growing problem of obesity and the prevalence of air conditioning over the last three decades.

Mammals, they say, use up more energy to maintain their bodies at an acceptable temperature.

The more time humans spend in a climate-controlled environment, the less their bodies have to work. They also suggest people tend to eat less when theyre hot.

"If you lived in Alabama in the summer of 1960, without air conditioning in a car or restaurant, you probably wouldnt want to go to an all-you-can-eat buffet," said David Allison, a researcher at the University of Alabama at Birmingham.

Allison said other factors could also contribute to weight gain, such as over-medication. He said the widespread use of anti-psychotics, anti-depressants, mood stabilizers, contraceptives and antihistamines, all can cause users to put on pounds.

The researchers urged their colleagues to focus on some of the unexamined causes of obesity, and not so much on fast food and lack of exercise.

The Food and Drug Administration has yet to make companies break the habit of marketing laser treatment smoking cessation, a therapy the FDA has never approved, and a therapy which some professionals believe to be ineffective.

Dr. Sidney Wolfe, Health Research Group director of the Public Citizen, a nonprofit consumer advocacy group, decried the procedure's continued availability and the FDA's inaction.

"Medical evidence, in the form of properly conducted clinical trials, demonstrates that its effectiveness is indistinguishable from that of a placebo," Wolfe said.

Public Citizen petitioned the FDA on June 22 to immediately stop five companies from "illegally marketing and promoting laser treatment for smoking cessation."

Freedom Laser Therapy (FLT), based in Santa Monica, Calif., has taken the most heat for its website and marketing procedures.

But Craig Nabat, FLT president told ConsumerAffairs.com that the procedure works. "The lower power lasers cause an endorphin release that tricks the mind and body," he said.

However, Nabat said that the laser is just the catalyst and that the person must take over-the-counter antioxidants and continue to watch videos that come with the procedure in order to quit smoking.

Nabat would not say what percentage of FLT customers have successfully quit smoking. He said he has hired a private research firm to document the procedure's results.

Nabat said FLT has been around since Sept. 2003 and that if it didn't work he would be out of business by now. "This procedure has been around for 30 years in Canada and Europe," he said.

Soon after the Public Citizen petition, FLT stopped all advertising and pulled down the great majority of content from its website.

"We want to make sure everything is compliant," Nabat said.

Wolfe said FLT has been targeted for its "considerable web and TV hype." Nabat believes that his company is under fire because it is "the most high tech."

Wolfe told ConsumerAffairs.com that this $349 procedure is harmful because people trying to stop smoking waste their money and often give up quitting after this "too-good-to-be-true" procedure doesn't work.

Wolfe said smokers trying to quit should use FDA-approved methods such as nicotine gum and the patch along with regular doctor visits. Wolfe said it's easier to tackle the mental portion of the addiction if there is someone, such as a doctor, coaching the quitter.

FDA spokeswoman Heather Howe did not return phone calls seeking comment.

Even after a FTC scolding and several class action lawsuits, Mantra Films, the makers of "Girls Gone Wild," are still making it difficult for consumers to cancel their subscriptions, according to consumer complaints filed with ConsumerAffairs.com.

In July 2004 the FTC ordered Mantra to pay $1.1 million for "enrolling consumers who responded to Internet and television ads advertising a single video or DVD into "continuity" programs.

Once consumers were enrolled in these programs, each month the defendants shipped additional, unordered videos and DVDs on a "negative-option" basis, charging consumers' credit and debit cards for each shipment until consumers took action to stop the shipments."

Consumers then found it nearly impossible to cancel the continuity program.

As a result of that case, Mantra was forced to make it undeniably clear what the consumer was signing up for and also follow through with the late night TV ads' promise of, "cancel any time."

To enforce this ruling, the FTC forced Mantra to submit compliance records for 180 days after the case. The commission can also ask for more compliance records after that date if necessary.

Two years later, Mantra is still advertising all over late-night TV and the complaints file into ConsumerAffairs.com on a daily basis.

"I purchased 2 DVDs for $9.99 -- cancel any time," wrote Julian of Walnut Creek, Calif. "They began to send me 1 or 2 DVDs each month. I picked up on that quickly and tried to cancel my account. Over the course of several months I have called four times each time insisting that my orders be cancelled and that they stop billing me and stop sending me DVDs. Atrociously the DVDs continue to come despite all my efforts. They have taken over $250 from me."

Although it does seem clear from recent consumer complaints and the "Girls Gone Wild" website what a person is signing up for, almost every complaint is about Mantra's apparent disregard of its "cancel anytime" promise.

There's no telling whether the FTC is doing anything.

"I can't confirm or deny any investigation," Robert Frisbee, FTC assistant director said.

Mantra, based in Hollywood, Calif., appears to be safe from local authorities as the California Department of Justice has not filed any suit nor does it have any current investigations.

Frisbee did confirm that the FTC requested more materials from Mantra once, but would not share any more specifics. "Our correspondence is not really a matter of public information," he said.

Smokers who pay to be zapped by lasers in an effort to kick the habit are victims of fraud, according to the watchdog group Public Citizen.

Public Citizen has asked the U.S. Food and Drug Administration to stop five companies from promoting low-power laser therapy as a means to quit smoking.

The clinics -- Freedom Laser Therapy Inc., the Anne Penman Laser Therapy clinics, New Beginnings Laser Therapy, Laser Concept and the Stop Smoking Laser Center -- are marketing laser therapy as a safe and effective smoking cessation treatment despite the lack of FDA clearance or any evidence that it is effective, according to Public Citizen.

Laser therapy, also known as laser acupuncture, aims a low-power laser beam rather than needles at various points of the body. It is approved by the FDA for marketing only for the temporary relief of pain.

Public Citizen focuses on Freedom Laser Therapy (FLT), which has generated the most news coverage of its activities. FLT claims an 85 percent success rate for curing smoking addiction in just one 30-minute session.

The therapy program costs $399 for the single 30-minute session. According to the Public Citizen petition, the money would be better spent on treatments that have been proven to show some success: nicotine replacement therapy, physician advice, certain antidepressants and individual behavioral counseling.

FLT President Craig Nabat says he wants to open franchises nationwide despite solid evidence that the stop smoking program works.

Early attempts at following up with all clients proved laborious, expensive and ultimately fruitless, Nabat said. "We are not documenting exactly how many people are coming through -- how successful they are," said Nabat, adding that client referrals vouch for the program's effectiveness.

FDA regulations do allow the therapy to be used in investigational clinical trials or studies -- exactly what FLT said it is carrying out at its two locations, in Royal Oak and Santa Monica, Calif.

Dr. Norman Edelman, chief medical officer of the American Lung Association said that there is no evidence that the laser program works.

Public Citizen charges that that "despite a lack evidence supporting its claims, the company has launched an aggressive marketing campaign to recruit a wide audience of vulnerable clients who are looking to stop smoking."

"In all of its advertising, FLT presents laser treatment as a much more credible option than has been shown in the medical literature," Public Citizen claims.

DaimlerChrysler plans to sell its 60-mile-per-gallon two-seater Smart Car in the U.S. next year.

The little Smart Car is just more than 8 feet long and less than 5 feet wide and is small enough to fit in half of a typical parking space.

The three-cylinder turbocharged Smart Car can achieve up to 60 mpg, according to DaimlerChrysler.

The automaker hopes to broaden the market for Smart Cars, which have lost money since DaimlerChrysler's Mercedes-Benz unit launched the program in 1998.

Mercedes took a first-quarter charge equivalent to $1.5 billion, including costs associated with scrapping the slow-selling four-seat model of the Smart Car.

The decision comes as growing numbers of U.S. consumers are worried about rising gasoline prices and smaller more fuel-efficient vehicles are attracting their attention.

AT&T is unveiling its new privacy policy, saying it does not share customer information with third-party marketers, but may share the data with government agencies.

AT&T telephone customers can expect their calling records to be among those scrutinized for terrorist links. The company will also collect information about which Web sites its Internet customers visit, including what links they click on.

"While your account information may be personal to you, these records constitute business records that are owned by AT&T. As such, AT&T may disclose such records to protect its legitimate business interests, safeguard others, or respond to legal process," the company said in its new policy statement.

However, Congress may place limits on how government agencies can access this personal data. Sen. Hillary Clinton (D-NY). in a speech to the American Constitution Society, called for a "Privacy Bill of Rights."

"At all levels, the privacy protections for ordinary Americans are broken, inadequate and out of date. It's time for a new comprehensive look at privacy," Clinton said.

"We need consumer protections that are up to date with the technological and national security needs of our time, for a world in which we can be confident that our security and our privacy are both protected."

Clinton has said that she will introduce the Privacy Rights and Oversight for Electronic and Commercial Transactions Act of 2006, the PROTECT Act. Meanwhile, Congress is set to review actions of AT&T and other telecom companies for their reported cooperation with a National Security Agency program that scanned millions of phone records for terrorist links.

MySpace.com is being sued for $30 million on behalf of a 14-year-old Texas girl who says she was sexually assaulted by someone she met through the site.

The suit claims MySpace was negligent for not verifying the ages of users and for failing to prevent strangers from contacting users under 16.

The defendants are MySpace, its corporate parent News Corp., and Pete Solis, the 19-year-old accused of sexually assaulting the teen. The girl's lawyer said the damages requested reflect one percent of the site's estimated worth.

MySpace has been the target of criticism and legal actions lately by educators, parents and some state attorneys general who say the site isn't doing enough to safeguard its users.

It's not for lack of trying. MySpace has been trying to clean up its act for months and recently hired former Microsoft executive and onetime federal prosecutor Hemanshu Nigam as chief security officer as its chief security officer.

The site is expected to announce a series of new safety and security, including heightened measures for the 14-15 year old set, new options for privacy and age-approporiate advertising placement.

Published reports of the changes say that anyone over 18 who wants to contact members under 16 will need to know the first and last names or the email address in order to make the connection.

Attorney General Greg Abbott charges that while the chemical composition of the gasoline pill may well be top secret the pill is also a scam. Abbott says the pill is nothing more than the equivalent of a mothball.

With the price of gasoline reaching $3 a gallon, scammers are polluting the market place with gimmicks and products designed to take advantage of consumers beaten down by the high prices.

With drivers searching for alternatives to high-priced gasoline, a cottage industry is sprouting up claiming increased mileage with pills, powders, liquid additives and mechanical devices.

The little green BioPerformance pill is suppose to improve mileage by 30 percent when simply dropped into a gas tank. Abbot says the claim is nonsense and has filed a suit to shut down BioPerfomrance in Texas. Abbott recruited a University of Texas scientist to test the product and it turns out the pill is made of naphthalene.

Mothballs are also made from naphthalene.

The little pills are not the only scam on the market. Among the mileage rip offs are a set of magnets that can be attached to the fuel line so they can realign the gasoline molecules and create "vortex generators" forming small tornadoes inside the engine.

All the magnets really generate are profits for the people selling them.

The small green BioPerformance pills are advertised as completely harmless and non-toxic according to company claims. Naphthalene, however, can be quite toxic and is harmful if swallowed or ingested.

BioPerformance claims to have 4,500 sales people in Texas with $25 million in revenue since December 2005. But the company turns out to be more like a pyramid scheme. Dealers must come up with $300 to $500 to pay for start up costs.

College students. They're young. They're impressionable. They're dirt poor. And they're perfect candidates for multi-level marketing (MLM) and pyramid schemes.

During my college days at St. Bonaventure University, I saw this with my own eyes and reported the sad story in the student newspaper. I saw how one man and his white board fooled six destitute young students into a system from which only he would profit. What started as making $7.50 triumphantly ballooned to hundreds of thousands of dollars. In his cookie cutter speech, the man never said the words "introductory fee" or "sales."

As one business professor I interviewed for the story said, "It looks like a duck. It walks like a duck. It is a duck."

That particular MLM was a notorious one called Quixtar, a/k/a Amway. It's just one of hundreds of companies profiting from the hunger on college campuses.

MLMs are technically legal while pyramid schemes are not. However, the fine line between the two is hardly visible. According to New York Attorney General Elliot Spitzer's website, what separates an MLM from a pyramid scheme is that a pyramid scheme requires investors at the bottom of the pyramid to invest in generally unwanted products and pay an initial introduction fee.

In a pyramid scheme, people are given direct commissions based on recruiting members. The people at the top of the pyramid structure make money from that original investment and not on the sale of products. MLMs use a pyramid structure but commissions are based more on sales than on recruiting.

The ConsumerAffairs.com database is filled with many sad stories of young students hoping to reverse their debt.

"I went to an interview (or so I thought) where I listened to a presentation in which a gentleman described how much money I could make and how controlling that corporate America really is," wrote Jennifer of Kansas City, Mo. "Needless to say I was young and insecure and fell easily into believing these people cared about me and my future."

"I was talked into buying $3000 worth of products within the first week, which was my entire savings. I was also talked into renting desk space, getting a phone line installed, going to training sessions all over the US every month, and to continue to buy products not only for myself, but to sell as well," Jennifer said.

"(They) made it appear that I could be rich within a year, they even tried telling me that I could move to San Diego to help start the 'new office' and that I would be the first in that market."

But it didn't turn out quite that way.

"After several months, all of my credit cards were maxed out, they had talked me into taking a leave of absence from my job, and I was barely paying the bills. I ended up spending over $14,000 on their promises of a better life. I had to file bankruptcy because I could no longer afford to live. Since then, not only did I lose money, I also lost credibility. I cannot get a decent car or home loan, I cannot get a credit card and I cannot move apartments for fear that when they check my credit report my application will be denied."

According to Spitzer's website, pyramid schemes are doomed to failure while MLMs may succeed -- for the people at the top of the pyramid that is. For more information read Spitzer's Don't get caught in a pyramid scheme. Also, attorney Joan Lisante reviews the pitfalls in her ConsumerAffairs.com story, Pyramids Belong in Egypt.

New Jersey has filed suit against Royal Caribbean Cruises alleging that the company violated the state's Consumer Fraud Act by changing a cruise itinerary -- from Bermuda to ports of call in the Canadian Maritime Provinces -- without providing passengers with a comparable itinerary and failing to issue refunds due to passengers.

The state's complaint, filed by the Attorney General's Office and Division of Consumer Affairs, alleges that Royal Caribbean engaged in unconscionable commercial practices regarding a planned cruise to Bermuda in July, 2005.

The state is seeking restitution for consumers and civil penalties for each violation of the Consumer Fraud Act. The Division of Consumer Affairs said it received 53 complaints from the cruise passengers since July, 2005. Passengers were allegedly told if they did not board the ship, despite the change in plans, they would lose all their money.

"We allege that Royal Caribbean misled customers about a planned itinerary change and then failed to refund consumers the difference in cost between the trip they purchased and the trip they received," said Attorney General Zulima Farber. "We are prepared to take legal action whenever necessary to ensure that consumers get what they pay for or are compensated for any changes."

Specifically, the complaint includes the following allegations:

• Royal Caribbean alerted passengers arriving at Cape Liberty in Bayonne for a July 24, 2005 cruise to Bermuda that the ship, the Voyager of the Seas, would instead sail to St. John, New Brunswick and Halifax Nova Scotia;

• Royal Caribbean made no attempt to personally alert passengers of the change prior to the July 24 departure date despite having passenger contact information and despite posting a notice of the change on its website the previous evening;

• When they arrived at Cape Liberty, passengers were given a Royal Caribbean customer service number in Florida where a representative advised passengers that they would lose all of their money if they did not board the ship;

• A cruise to Canada is significantly less expensive than a cruise to Bermuda;

• Royal Caribbean offered only an onboard credit of $45.20 - the difference in port fees and taxes - to each passenger and stated that this was the only refund to be provided;

• The temperature in Canada was significantly cooler than in Bermuda and the weather was rainy, cloudy and foggy;

• Passengers were deprived of the use of many of the Voyager of the Seas' outdoor amenities that they planned to use when they booked a cruise to Bermuda including the pool, Jacuzzi and nine-hole miniature golf course;

• Passengers were denied the opportunity to engage in warm weather activities available at the Kings Wharf, Bermuda port including golfing, scuba diving, glass-bottom boat cruises, snorkeling, deep-sea fishing, beach excursions and catamaran cruises; and

• While onboard and upon returning home, passengers requested a cash refund for the difference in cost between the Canada cruise and the Bermuda cruise and Royal Caribbean refused to honor any such requests.

"It is unconscionable that consumers showed up for a cruise they paid for with their hard-earned money only to be sent somewhere they didn't want to go, without access to the amenities they paid for and activities they looked forward to, and were told there was nothing they could do about it," said Consumer Affairs Director Kimberly Ricketts.

"This type of egregious behavior will not be tolerated in New Jersey and that is exactly why we have filed suit against Royal Caribbean."

Treating prostate cancer with radiation may slightly increase a man's risk of developing rectal cancer.

Researchers studied 86,000 men diagnosed with prostate cancer who did not have rectal cancer. About 35 percent received radiation treatments -- usually with small beads placed in the prostate. Sixty-five percent of this group were treated sufficiently.

However, a decade later a small number of them -- 267 -- had developed rectal cancer. The rectum is near the prostate.

While this rate is low, people treated with radiation had a 70 percent greater chance of developing rectal cancer than the control group. Radiation did not cause cancer in other parts of the abdomen.

So, the millions of men who have prostate cancer each year should go over the pluses and minuses of surgery versus radiation with their doctors. While the risk of rectal cancer from radiation is extremely low and may not be a problem for most men, it is there and should be taken into consideration.