Current Events in May 2008

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    Consumer Groups Urge the FCC to Reject XM-Sirius Merger

    Justice Department rubber-stamped the deal in March

    The Consumer Federation of America, Consumers Union and Free Press are urging the Federal Communications Commission to reject the proposed XM-Sirius merger.

    The Department of Justice signed off on the deal without attaching any conditions.

    In March, consumer groups criticized that decision as fundamentally flawed and called on the FCC to deny the transfer of the licenses to use the spectrum that XM and Sirius hold, which would effectively kill the merger.

    "The Justice Department tossed all tenets of antitrust out the window in its rush to rubber stamp this merger-to-monopoly," said Mark Cooper, director of research for the Consumer Federation of America.

    "The FCC should not buy into the flawed reasoning that led to the DOJ's disastrous decision. Consumers are depending on the commission to stop this dangerous deal dead in its tracks," he said.

    The Justice Department based its merger approval on the conclusion that satellite radio is part of a larger audio market.

    However, consumer groups -- using the FCC's own data on radio stations -- have argued that satellite radio and terrestrial radio are not close substitutes. The groups argue that satellite radio represents a unique consumer product that does not compete with iTunes or Internet radio.

    "Protecting consumers should be the FCC's first priority," said Chris Murray, senior counsel of Consumers Union. "Allowing one company to monopolize the satellite radio industry would leave consumers with higher prices and fewer choices but no real benefits. Rejecting this deal should be a no-brainer."

    The consumer groups' filing contends that the DOJ analysis ignores many aspects of competition between XM and Sirius that promote the public interest. In its analysis, the DOJ concedes that XM and Sirius:

    • Did compete to sign automakers to long-term contracts and continue to do so when those contracts expire;

    • Do compete for a great deal of programming, music, niche news and talk;

    • Do compete for marquee programming;

    • Do compete in retail distribution; and

    • Would have competed more if they had kept their promise to deliver an interoperable radio.

    As a consequence, permitting the two satellite radio companies to join would have many negative side effects -- both for consumers and for the satellite radio industry, the groups charged.

    For consumers, the merger would reduce the number of channels and formats available and result in fewer cost-saving incentives. The loss of competition in the industry would also cause a dramatic drop in spending on talent.

    "By approving this monopoly deal, the Justice Department has failed as the public's corporate watchdog," said S. Derek Turner, research director of Free Press. "Now it's up to the FCC to safeguard consumers and promote competition on our public airwaves."

    States oppose merger

    Earlier, eleven states called on the Federal Communications Commission (FCC) to consider blocking the proposed merger of the nation's only two satellite radio companies, saying the deal would create an illegal monopoly.

    "A merger of XM Radio and Sirius radio meets the textbook definition of monopoly: a product controlled by one party," said Connecticut Attorney General Richard Blumenthal. "The Justice Department's inaction regarding this combination defies law, reason and common sense. Even a child understands that owning every property from Baltic Avenue to Boardwalk is a monopoly.

    "This monopoly-making merger will leave Connecticut consumers at the mercy of a single company, leading to skyrocketing prices and diminished service. Customers unhappy with their service will have nowhere to go. The Justice Department's message to satellite radio consumers: Go pound sand.

    Among the opponents is the state of Wisconsin, whose attorney general, J.B. Van Hollen, said the proposed merger is anti-competitive and anti-consumer. He said its impacts will be felt in Wisconsin, particularly in rural communities, where he predicts a significant reduction in the availability of sports and other programming.

    The proposed merger would eliminate competition in the satellite radio industry and the combined XM-Sirius companies would be free to raise prices, stifle innovation, and reduce program diversity, Van Hollen said late last year, when he wrote to Barnett asking that the merger be blocked.

    The Justice Department said last week that the combined satellite company won't be able to raise prices excessively because of competition from other entertainment media, including broadcast radio and MP3 players.

    There wasn't enough evidence the merger "would substantially lessen competition or harm consumers," Justice antitrust chief Thomas Barnett said.

    FCC weighing its options

    FCC Chairman Kevin Martin has said the agency is close to a decision and said the FCC staff has been instructed to draft "various options."

    The deal has come under fire from critics who say it would reduce competition. The critics have also questioned whether existing receivers will be able to receive what proponents have said will be greatly expanded programming options.

    The proposed merger got a boost last September when former Federal Communications Commission chairman Mark Fowler said the deal would enhance competition. His comments came in a column in the New York Sun, whose parent company, Hearst Corporation, owns a stake in XM.

    "In spite of the fact that satellite radio constitutes only 3.4 percent of radio listening today, traditional over-the-air radio operators have understood the potential threat and have had no choice but to compete, and have been dragged, albeit kicking and screaming, into the digital age," Fowler wrote.

    The main argument that may prevent the current commissioners from allowing the merger is that it would create what critics say would be a monopoly. The National Association of Broadcasters (NAB), an industry group that lobbies on behalf of terrestrial radio broadcasters, has been by far the most vehement opponent.

    "The national satellite radio market currently is a two-company duopoly trying to become a government-sanctioned monopoly," NAB president and chief executive officer David Rehr said at a House hearing in March. "The fact is, this monopoly would reduce innovation for services and equipment for consumers since there will be no competition in their defined market."

    Consumer Groups Urge the FCC to Reject XM-Sirius Merger...

    Allergy-Free Grocery May Make Mothers' Lives Easier

    Virginia women learned about food allergies the hard way

    A Virginia Beach, Va., woman has opened what she is billing as an "allergy-free" grocery store to help parents whose children suffer from food allergies.

    Jennifer Elizondo left a lucrative job with a defense contractor to open the new grocery store. She became interested in the food allergy problem when her son Vaughn, 3, went into anaphylactic shock the first time he ate peanut butter.

    Grocery shopping became so complex that Elizonda decided to open Navan Foods, a grocery store to help her family and others who suffer with food allergies.

    There are several online stores offering allergy-free food products and most major supermarkets carry at least some allergy-free products but local allergy-free retail outlets are relatively rare.

    About six percent of children under the age of three have food allergies, and shopping for them can be exhausting, Elizonda noted.

    The most common food allergies among children include milk, eggs, peanuts, soy, wheat, tree nuts such as walnuts and cashews, fish, and shellfish, like shrimp.

    Most children will eventually outgrow food allergies, though peanut and tree nut allergies usually last a lifetime, meaning a lifetime of never leaving home without an EpiPen to administer an emergency, life-saving injection of epinephren.

    The opening coincides with National Food Allergy Awareness Week.



    Allergy-Free Grocery May Make Mothers' Lives Easier...

    Kroger Expands Its Generic Drug Discount Programs

    Latest Wal-Mart upgrade sets off competitive responses

    Kroger Co. says it won't be left in Wal-Mart's dust. It's upgrading its $4 generic drug program to meet the latest changes in Wal-Mart's program.

    Kroger unveiled its $4 program in February, modeled closely after Wal-Mart's plan which rolled out in 2007, offering many popular generics for $4.

    On May 6, Wal-Mart expanded its program to include orders for 90-day supplies and additional drugs to treat osteoporosis and breast cancer as well as cutting the price of more than 1,000 popular over-the-counter drugs in half, setting off competitive responses by many grocery chains, including Sweetbay Supermarkets, Hannaford Bros., Food Lion and Harveys Supermarkets.

    A Kroger spokesman said the new program is "very similar to Wal-Mart's."

    "Certainly we want to be very competitive in the marketplace," Kroger spokesman Gary Huddleston said. He declined to disclose sales numbers for the program but said that besides increasing drug sales, it has "helped introduce new customers to Kroger."

    Before the recent changes, Wal-Mart and Kroger included more than 300 generic drugs to treat common conditions such as diabetes, asthma, depression and heart disease on their lists of drugs costing $4 for a month's supply.

    Competitive turmoil

    While few grocery or pharmacy chains duplicate the Wal-Mart program, many have introduced similar programs and the number of outlets offering popular generics at reduced prices has increased substantially since Wal-Mart introduced its program, which started as a pilot project in Florida in late 2006.

    Target offers a similar program and Walgreen Co. sells a 90-day supply of generics for $12.99.

    Hannaford and Sweetbay launched their programs earlier this year Food Lion started last week. Harveys launched its program months ago, the trade paper said.

    The Sweetbay program is called Healthy Saver and covers more than 400 drugs, priced at $4 for a 30-day supply, or $10.99 for a 90-day supply. The programs at the other Delhaize stores are similar, although Harveys does not offer a 30-day option.

    Shop around

    But consumers should be sure to shop around. The most publicized programs are not always the cheapest.

    A survey released by Consumer Reports last week found that price fluctuations can be dramatic -- sometimes more than $100 for the same prescription even within the same chain, depending on whether consumers are filling their prescriptions in, say, Omaha, Nebraska, or Billings, Montana.

    Costco was the cheapest for the four drugs CR sought quotes for, followed by AARP.com and Wal-Mart. Walgreens and Rite-Aid were among the priciest for the four drugs.

    Consumer Reports said it placed more than 500 calls to 163 pharmacies nationwide to gauge price differences among four prescription drugs, three name brand medicines and one generic.

    Read more about the CR study ...



    Kroger Expands Its Generic Drug Discount Programs...

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      House Joins Senate in Boosting Rail Travel

      More Americans riding the rails as gas prices soar

      While rail ridership increased by record numbers, House legislation introduced late last week would invest $14.4 billion to promote rail travel, relieve bottlenecks and begin investment in a new generation of high-speed rail.

      The Passenger Rail Investment and Improvement Act of 2008 (HR 6003) would invest $14.4 billion over five years.

      This legislation wins the Triple Crown. In addition to providing Americans alternatives to paying high prices at the pump and the headaches of air travel, a revitalized rail system will save billions that would otherwise be spent on expanding existing airports and highways, said John Krieger, an advocate for transportation at U.S. PIRG.

      Americas economic competitors in Europe and Asia are spending billions for networks of high-speed rail traveling over 200 mph. In an age of oil scarcity, we cant afford to fall further behind.

      As with the Senate bill which passed 70-22 last fall, the House measure would establish a competitive state grant process for high-speed corridors with matching grants of up to 80 percent.

      Presently, highway projects typically receive federal matching money equaling this 80 percent level of cost sharing, while public transportation projects typically receive a 50 percent match.

      The proposed legislation also includes necessary funding for infrastructure repairs and investment in improved efficiency, unlike past passenger rail allocations which barely provided for operations along the system while long-term sustainability suffered.

      Amtrak reported the fifth straight record year for ridership in 2007. Meanwhile total vehicle miles for cars and trucks fell for the first time since the oil crisis of the 1970s.

      America needs to be investing in the trends of the future, and that means more and faster rail travel. Anyone who has been to a gas station or airport lately can see that, said Krieger.



      House Joins Senate in Boosting Rail Travel...

      Organic Milk: Are You Getting What You Pay For?

      Consumer group wants tougher enforcement, stricter rules

      Organic milk is one of the biggest areas of growth in the dairy industry, making up three percent of all U.S. milk sales and growing at a double-digit rate. It also commands a much higher price per gallon than regular milk.

      With so much money at stake, a consumer watchdog group charges some dairies are bending the rules to get more of their product classified as organic.

      Which dairy farm is "organic?" Maybe both?

      The Cornucopia Institute, a farm policy research group, has filed a complaint with the U.S. Department of Agriculture claiming that a California supplier to one of the nation's largest organic labels is skirting the law. Specifically, the group charges the diary confines most of its cows to a feedlot rather than allowing them fresh grass and access to pasture as the federal organic regulations require.

      "We are asking the USDA, once again, to investigate serious alleged improprieties at dairies that produce Horizon organic milk," said Mark A. Kastel, Senior Farm Policy Analyst with the Wisconsin-based Cornucopia Institute.

      Horizon is owned by Dean Foods, one of the nation's largest dairies.

      Cornucopia has fought this battle before. Last September the group was successful in lobbying USDA to threaten action against Aurora Organic Dairy, a supplier of organic milk to a number of national chain stores.

      The company made changes to its practices after USDA disclosed it had threatened to revoke Aurora's organic certification because the company had committed 14 "willful violations" of federal standards.

      What is it?

      Federal regulations defining what exactly constitutes organic milk are somewhat vague.

      The New York Times recently noted that "organic milk" essentially means "it comes from a cow whose milk production was not prompted by an artificial growth hormone, whose feed was not grown with pesticides and which had 'access to pasture,' a term so vague it could mean that a cow might spend most of its milk-producing life confined to a feed lot eating grain and not grass."

      While consumer groups like Cornucopia complain that dairies bend the rules, the dairies complain the rules lack specificity.

      The International Dairy Foods Association, a Washington lobbyist for the dairy industry, is pleased to see the growth in organic milk sales, but leery of establishing a mystique about it, lest it eclipse it's other non-organic products.

      "The term organic refers to farm practices, not to the milk itself," the group says on its Web site. "Milk and dairy foods are among the most tested and regulated foods in this country. While organic dairy farmers use only organic fertilizers and organic pesticides and their cows aren't treated with synthetic hormones, the milk itself is the same as the milk produced conventionally."

      Cornucopia's complaints have mainly to do with the number of cattle kept on organic dairy farms and the way they are housed.

      Cornucopia's most recent complaint is the third filed with the USDA alleging Dean Foods has broken the federal law that governs organic production. Prior complaints also charged Dean was confining cattle on their two company-owned dairies, managing as many as 8,000 head of cattle each.

      Pastureland

      The group has also expressed concern that the cows spend most of their time confined to cramped feed lots, with just enough "access to pastureland" to meet the letter of the law. The group charges many dairies fail to meet the law's intent.

      "In the eyes of consumers, factory farms with questions about humane animal husbandry and records of endemic pollution do not meet the ethical litmus test," Kastel said.

      Pressure is growing on USDA to more clearly spell out exactly how much access dairy cows should have to pasture grazing before their milk can be legally labeled as "organic."

      Even some farmers want the rules more clearly defined, to help them avoid running afoul of the law. And as demand for organic milk continues, more farmers are beginning to move into that space.

      "The popularity of organic milk has already resulted in many conventional farmers choosing to raise cows without the use of artificial growth hormones," said Dr. Alan Greene, a pediatrician at Lucile Packard Children's Hospital, and Stanford University clinical assistant professor of pediatrics.

      "This is a big accomplishment, brought about by consumer trends. If we keep choosing organic milk, we can expect similar changes in the whole system - as well as good nutrition -- and a cleaner environment -- for our families."

      But only, say consumer groups, if milk labeled as organic is truly organic.

      The Cornucopia Institute says that while more clearly defined parameters would be helpful, tougher enforcement of existing rules is needed to insure consumers are getting what they're paying for when they spend more to buy organic milk.



      Organic milk is one of the biggest areas of growth in the dairy industry, making up three percent of all U.S. milk sales and growing at a double-digit rate...

      Class Action Alleges Deceptive Marketing by Lifelock

      Lifelock's CEO is himself a multiple identity theft victim, suit charges

      A West Virginia law firm has filed its third class action lawsuit against Lifelock, whose ubiquitous ads promise ironclad protection against identity theft. Earlier suits were filed in New Jersey and Maryland.

      The lawsuits, filed by Marks & Klein, LLP, allege that LifeLock and its multi-million-dollar advertising campaign provided false and misleading information about the limited level of identity protection the company provides, and failed to warn them about the potential adverse impact the company's services could have on their credit profiles.

      The complaints also allege that the firm's CEO, Richard "Todd" Davis, has himself been a victim of identity theft by multiple offenders while a customer of LifeLock's services.

      Davis publishes his Social Security number in the Lifelock ads as a demonstration of his supposed confidence in the company's practices.

      Protection 'overstated'

      Attorney David Paris maintains that LifeLock dramatically overstates the level of protection provided by its primary service -- the placement and constant renewal of fraud alerts on its subscribers' credit profiles.

      "Customers of LifeLock rely on the company's misleading advertisements and pay for a perceived level of protection that is clearly not provided," said Paris.

      LifeLock, which is headquartered in Tempe, Ariz., charges subscribers $10 per month. According to the complaints, potential LifeLock subscribers are enticed by the 'safety net' of what appears to be a $1 million insurance policy against any losses sustained as a result of identity theft.

      "In actuality, once you get beyond the numerous legal limitations and disclaimers, the policy really only guarantees that LifeLock will investigate how to fix its failure if an incident occurs and will pay other third-party organizations to attempt to restore the subscriber's identity," noted David Grubb of the Grubb Law Group in Charleston, W. Va., who is representing West Virginia class plaintiffs.

      "The subscriber receives no monetary recompense and no guarantee that their reputation and credit status will be restored," he said.

      According to the complaints, LifeLock induces consumers into subscribing through a marketing campaign that showcases CEO Davis broadcasting his own Social Security number as testimony to his confidence in Lifelock's services.

      CEO's identity stolen

      As a result, the complaints allege, Davis's identity has been "stolen while he was a customer and is, upon information and belief, presently being misappropriated by at least twenty identity thieves."

      The West Virginia action seeks to recover the money subscribers have paid to LifeLock and to prohibit the company from continuing to promote its services through a deceptive marketing campaign. Marks & Klein said it plans to file similar actions on behalf of consumers in other states.

      Founded in 2005, LifeLock presently has approximately 1 million subscribers across the United States.

      Debit card incident

      Beyond the charges leveled in the complaints, lead counsel Paris related the story of a Wisconsin consumer who contacted the firm regarding her accidental experience with LifeLock.

      "Her debit card was stolen and the thief had the audacity to use the card to buy a subscription to LifeLock," he noted. "Most disturbingly, LifeLock issued the subscription to the thief in the thief's name, clearly failing to verify the appropriate information."

      DIY

      Consumer advocates say that the service provided by Lifelock is little more than a "concierge" offering, something that consumers could do themselves for free.

      LifeLock, based in Tempe, Arizona, works by renewing an individual's fraud alert with one of the nation's three large credit bureaus, a service which federal laws mandate any individual can do for free, usually within a few minutes over the phone or Internet.

      What the fraud alert does is it basically puts a red flag on your credit report and it tells any potential creditor that if they receive an application for credit, they should take additional measures to determine that the person is the person that they're claiming to be. Typically that would be a phone call, said Paul Stephens, director of public policy at the Privacy Rights Clearinghouse, a nonprofit consumer advocacy organization.

      Fraud alerts last 90 days and then must be renewed. LifeLock charges $10 a month to make sure its customers' fraud alerts never expire a service most consumer advocates are baffled anyone would pay money for.

      No one needs to pay a third party firm to assert their federal rights, Ed Mierzwinski, consumer program director at the U.S. Public Interest Research Group, a nonprofit consumer advocacy organization, wrote in an e-mail. And for one hundred bucks plus each year, it is certainly not cheap to do so.

      Concierge service?

      I like to think of LifeLock as being a concierge service, Stephens said Are you the kind of person who would pay somebody, for example, to do your shopping for you?

      I would point out that to do the sorts of things that LifeLock does for you, you don't even need to leave your house, Stephens continued. You can get on the phone or get on your computer and do it in a couple of minutes. So I don't really see that they bring a lot of value to the consumer.

      Davis didn't argue the concierge analogy in a phone interview with ConsumerAffairs.com, but said the company offers much more than the renewal service.

      There are certainly steps beyond just convenience that we're doing, but one of the things that people love are those convenient steps: us renewing the fraud alerts, us being there if you have a question in a retail store when you're applying for credit, us being available 24/7, us being there in case you lose your wallet; (we will) assist canceling and renewing credit cards and helping to get a new driver's license, Davis said.

      We're also doing other things like scouring the (Internet) looking for your personal information being bought or sold on the black market, Davis said. We're authenticating when someone puts in a change of address to confirm it's you.

      In advertisements, the company also promises to stop junk mail, including pre-approved credit offers and provide a credit report services that again, a consumer can do for free over the phone or Internet.

      $1 million 'guarantee'

      The most controversial aspect of LifeLock is its $1 million guarantee.

      LifeLock's $1 million guarantee is our intent to go support any member of LifeLock who might become a victim of identity theft while subscribed to our service so we that can go out and (fill) our intent to do everything the law allows us to do to help that person recover their good name, Davis said. So whether that's hiring third person personnel, whether that's covering any losses or expenses, whether it's getting accounts closed and getting new ones issued, that's what we'll do.

      But two pending class action lawsuits claim that the company's $1 million guarantee is not a guarantee at all, but just a promise that the company is not actually obligated to fulfill.

      There is no $1 million guarantee, said Leonard Aragon, one of the attorneys who filed a class action lawsuit against the company. If you look at the terms of the contract it very clearly says 'we won't pay consequential damages. We won't pay you directly so there's really no way to get up into the million dollars.'

      Our understanding is that it basically covers any defect in their product, said Aragon of Hagens Berman Sobol Shapiro in Seattle. What that means is the failure to place the fraud alert or maybe they accidentally spell your name wrong.

      Davis said the reason LifeLock does not make any actual guarantees is because he doesn't want it to become an insurance company.

      Insurance by design is not built to mitigate risk. Davis said. They spread actuarial risk over a group of people. LifeLock is so dramatically more than that. We want to be the most comprehensive solution out there to actually prevent this crime to mitigate the risk on the front end. We don't want to limit what we can do for consumers. We don't want to limit where they can acquire this protection by only going through licensed insurance agents. We want you to be able to go get this at Office Depot or CVS Pharmacy or through AAA.

      85 claims

      Of LifeLock's 940,000 customers 85 have filed claims against the company's $1 million guarantee and all have been pleased with the results, Davis said.

      Those are some of our greatest advocates, he said.

      But Aragon warned that although the company is fulfilling its promise now, if there is ever a serious data breach and many of its customers are defrauded, the company may not fulfill its promise. He compared it to the insurance companies who failed to honor their flood clause for consumers whose homes were destroyed in New Orleans from a breached levy rather than flood waters.

      When everyone's all happy and it really isn't that big of a deal and there really aren't that many claims, well insurance companies say 'sure, we'll pay that. We don't want to cause trouble because we want people to come to our insurance company. But when it hits the fan and there are a lot of claims well that's when we start going into the contracts,' Aragon said.

      You can't promise one thing and have your contract say one thing because eventually that's going to come around and it's going to be bad news for the consumers who thought they were buying protection when in actuality they weren't buying anything, Aragon said. They were buying some good customer service. Big deal.

      Davis said no matter what, the company will honor its promise and that its terms are only written that way to avoid becoming an insurance company, and thus subject to regulation in each state where it does business.

      If we didn't (honor our guarantee), it would be catastrophic for the company, Davis said. It wouldn't behoove us in the business we're in when our sole purpose is protecting consumers and taking care of consumers if we elected to say we choose not to keep our promises then it's going to be catastrophic to the company.

      Despite the language of the $1 million guarantee, Aragon and consumer advocates say LifeLock is no guarantee to ward off fraud or identity theft.

      They're telling everyone this is LifeLock so we're going lock your credit and we're going to protect you from identity theft when the reality is all they do is put a fraud alert and all that does is protect you from having instant credit taken out under your Social Security number, Aragon said.

      Let's say you get your wallet stolen and your checkbook stolen and someone goes to a checks cashed store. It does nothing to protect against that. Aragon continued. It also does nothing to protect against your credit card (being) stolen.

      Fraud alerts do not stop the issuance of credit, Mierzwinski wrote. They do condition the issuance of credit by making the creditor liable if the consumer can prove damages, but they dont stop it.

      Davis said if a LifeLock customer is defrauded in any way, even outside the limited protection of a fraud alert, the customer can invoke the $1 million guarantee and the company will honor it.

      What to do

      Consumers who wish to sign up for the 90-day fraud alert or a credit report, can do so for free at any of the three major credit bureaus' websites or by calling them. Once one of the credit bureaus has been notified of the fraud alert, it will immediately notify the other three.

      • TransUnion: (800) 680-7289
      • Equifax: (800) 525-6285
      • Experian: (888) 397-3742

      Consumers who wish to opt out of credit offers can do so by calling the Consumer Credit Reporting Industry at (888) 567-8688 or by visiting its website.

      Class Action Alleges Deceptive Marketing by Lifelock...

      FDA OKs Health Claims for Brown Rice

      'Whole Grains' logo can now be displayed on brown rice, agency decrees


      The U.S. Food and Drug Administration has agreed to add brown rice list of whole grains that may make health claims including reducing the risk of heart disease and some cancers.

      Brown rice had previously been excluded because its dietary fiber content was considered too low but will now be allowed to display a whole grains logo and information pointing out the benefits of consuming whole grains.

      Whole grain foods can help reduce the risk of heart disease and many cancers, health officials say.

      "Rice is the most popular grain around the world, which makes brown rice a great choice for increasing whole grain intake," says Joann Slavin, Ph.D., R.D., whole grains expert and Professor of Food Science and Nutrition at the University of Minnesota.

      "In the United States, where chronic diseases such as heart disease and cancers are common, encouraging whole grain brown rice consumption could have a significant public health impact."

      Brown rice contains beneficial phytonutrients including antioxidants, anthocyanins, phytosterols, tocopherols oryzanol and many other potentially protective substances that have been found to help reduce the risk of heart disease, certain cancers, type II diabetes and potentially aid in weight maintenance.

      Brown rice also contains 15 vitamins and minerals, including B-vitamins, potassium, magnesium, selenium, iron, and 2 grams of fiber per one half cup of cooked rice.

      U.S. dietary guidelines recommend "making half of all grain servings whole" or consuming three whole grain servings per day in the average 2000-calorie diet.

      Yet data from a recent consumer survey conducted by EatingWell magazine and the USA Rice Federation show that the majority of Americans (65 percent) don't eat anywhere this amount.

      Under the reform, all single ingredient whole grain foods are eligible to make the health claim as long as they meet broad health claim requirements.

      The dietary fiber aspect of the health claim has been a bone of contention since 1999 when the claim was established because it favored high fiber content over total nutritional composition.

      The fiber relaxation will please groups such as the flax industry that are yet to receive the approval brown rice has won, a cause of acrimony to an industry that feels unfairly persecuted by anachronistic laws.

      According to the EatingWell/USA Rice survey:

      • 87 percent of US consumers know that whole grains are good for them.

      • 80 percent know whole grains can be protective against cardiovascular disease, but less than two-thirds are aware they also offer protection against certain cancers.

      • While 80 percent of consumers know that brown rice is a whole grain, more than 80 percent also mistakenly think that bran cereal and breads marked simply as "wheat" are also whole grains.

      • 80 percent of individuals said they would be likely to eat more whole grains if these foods were clearly labeled as whole grains

      • 68 percent said they would increase consumption if the health benefits were stated on the package.

      Research indicates rice eaters are more likely to meet dietary guidelines than non-rice eaters.



      FDA OKs Health Claims for Brown Rice...

      Supermarkets Launch Generic Drug Discount Programs

      Competition heats up but consumers still need to shop around

      Several major supermarket chains are launching discount generic drug programs, intensifying competition with Wal-Mart, which last week launched "Phase 3" of its highly-successful generic discount plan, adding more generics and over-the-counter drugs as well as a 90-day supply of some generics ofr $10.

      Sweetbay Supermarkets, Hannaford Bros., Food Lion and Harveys Supermarkets have all launched discount generic programs or will soon do so, Supermarket News reported. The chains are all owned by Delhaize Group of Brussels.

      Hannaford and Sweetbay launched their programs earlier this year Food Lion started last week. Harveys launched its program months ago, the trade paper said.

      The Sweetbay program is called Healthy Saver and covers more than 400 drugs, priced at $4 for a 30-day supply, or $10.99 for a 90-day supply. The programs at the other Delhaize stores are similar, although Harveys does not offer a 30-day option.

      Walgreen Co. sells a 90-day supply of generics for $12.99.

      Wal-Mart last week announced it was adding more generic drugs to its discount sales promotion, in which the commonly prescribed medication is sold from $4 for a 30-day supply to $10 for a 90-day supply. The retailer says "Phase 3" of its plan, which began in 2006, will also include some over-the-counter medication.

      Shop around

      But consumers should be sure to shop around. The most publicized programs are not always the cheapest.

      A survey released by Consumer Reports last week found that price fluctuations can be dramatic -- sometimes more than $100 for the same prescription even within the same chain, depending on whether consumers are filling their prescriptions in, say, Omaha, Nebraska, or Billings, Montana.

      Costco was the cheapest for the four drugs CR sought quotes for, followed by AARP.com and Wal-Mart. Walgreens and Rite-Aid were among the priciest for the four drugs.

      Consumer Reports said it placed more than 500 calls to 163 pharmacies nationwide to gauge price differences among four prescription drugs, three name brand medicines and one generic.

      Read more about the CR study ...



      Supermarkets Launch Generic Drug Discount Programs...

      FDA Approves Generic Drug for Restless Legs Syndrome

      Requip also approved for treatment of Parkinson's disease

      The Food and Drug Administration has approved the first generic versions of a drug for the treatment of moderate to severe Restless Legs Syndrome.

      Requip (ropinirole hydrochloride) tablets have been approved in dosages of 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligrams, 3 milligrams, and 4 milligram4.

      Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc., have been given the go ahead to market ropinirole hydrochloride tablets.

      The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease.

      The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.

      The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving.

      Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.



      FDA Approves Generic Drug for Restless Legs Syndrome...

      Chicken Labels Can Be Misleading

      'Free range,' 'grain-fed,' 'natural' don't necessarily mean much

      Buying chicken these days is not like it used to be. With labels like "100 percent natural," "organic," "grain-fed," and "free range," many consumers don't really know what they're buying.

      Federal regulators recently demanded that Tyson Foods remove "raised without antibiotics" from its chicken label. The U.S. Department of Agriculture originally approved the slogan, but later said it erred.

      USDA is also taking a closer look at labels that proclaim "100 percent natural." According to USDA, those words mean the poultry doesn't contain artificial ingredients like preservatives. But, experts warn, there are no guarantees.

      "100 percent natural remember, no inspections are done. So we don't know if those claims are really true," says Shannon Wallace, R.D., registered dietitian with Baylor University Medical Center at Dallas.

      Chicken labeled as "organic" must meet much stricter standards. Inspections are conducted and organic chicken cannot contain artificial ingredients, hormones or antibiotics. But are those really harmful to consumers?

      "The USDA does not make any claims that organically produced food is any safer or more nutritious than conventionally produced food," Wallace said.

      Another popular chicken label is "grain fed." This is supposed to mean the chicken was not fed animal byproducts, but just like "100 percent natural" and "free range," there is no outside monitoring for this claim.

      And probably the most confusing label of them all is "free range." Chicken labeled as "free range" is supposed to be leaner, but again, experts warn the claim can be deceiving.

      "Free range does not always mean that the animal has been in an open area its whole life. It may only mean they were in a restricted area and let out into that open area one time during their life," said Wallace.

      So what should you shop for in chicken?

      "If you would like to have a healthy diet, trimming the fat or buying leaner cuts of meat is always important. And the research is still out regarding these other issues of hormones and antibiotics," Wallace said.



      Buying chicken these days is not like it used to be. With labels like "100% natural," "organic," "grain-fed," and "free range," many consumer don't really ...

      AMA Calls For Tighter Drug Ad Oversight

      Many of the ads are misleading, doctors complain

      It's hard to turn on TV without being bombarded with ads for prescription drugs, offering cures for everything from EDS to acid reflux. The American Medical Association says many of the ads contain misleading information and need tighter controls.

      AMA President-elect Dr. Nancy Nielsen expressed her organizations concerns in testimony before the House Energy and Commerce Committee Subcommittee on Oversight and Investigations.

      "Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," said Nielsen. "Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs."

      Critics have long pointed out that consumers are in no position to purchase prescription drugs without their doctor. The sole point of advertising to consumers, they claim, is to prompt consumers to specifically request a particular prescription drug.

      At the hearing, the AMA discussed the need for FDA regulation over DTCA and shared guidelines for DTCA that address advertising content, disclosures, and audiences targeted.

      "The AMA guidelines for DTCA can help ensure that patients receive information about prescription drugs that is accurate, educational, well-balanced and encourages patient-physician communication," Nielsen said.

      "We look forward to working with Congress to achieve our shared goal - that direct-to-consumer advertisements focus on truly helping patients rather than maximizing pharmaceutical companies' bottom line," she added.

      The ads work

      A study last year bolsters the doctors' argument. A poll of Pennsylvania adults, taken 10 years after the first direct-to-consumer pharmaceutical television advertisement ran, suggests that nearly half of the participants have asked their doctor about a specific prescription drug or medical procedure they saw advertised.

      According to The Patient Poll, conducted by the Pennsylvania Medical Societys Institute for Good Medicine, 45 percent of Pennsylvania adults participating in the summer 2007 poll indicated that they have talked to their doctor about a specific drug and/or procedure that they saw advertised on television or in a magazine.

      Critics of the ads say they lead to more prescriptions being written, often when it's not in the best interest of the patient. But theres also a flip side: instead of getting upset about this situation, one physician says its better for his colleagues to be prepared for questions.

      Most physicians are divided about whether or not pharmaceutical advertisements directed towards patients are good, said Dr. Peter Lund, founder of the Pennsylvania Medical Societys Institute for Good Medicine.

      Some say its good to have patients informed, while others say its bad because of induced demand and incorrect self-diagnosing. Our advice to Pennsylvania physicians is to be alert to whats being advertised and be prepared to answer questions since theres a good chance theyll be asked.

      A study published in the August 16, 2007, edition of The New England Journal of Medicine tracks a rise in total spending on pharmaceutical promotion from $11.4 billion in 1996 to $29.9 billion in 2005. Real spending on direct-to-consumer advertising increased by 330 percent during those years.

      Theres clear evidence that the pharmaceutical industry is spending more to promote medications, Lund, an Erie, Pennsylvania urologist and incoming president of the Pennsylvania Medical Society, said. If it wasnt working for them, they wouldnt be pumping more money into that budget area.

      While direct-to-consumer pharmaceutical advertisements can be traced back to 1981, the debate on advertising directly to patients accelerated within the medical community 10 years ago when the Food and Drug Administration changed policy to allow television advertisements directed towards patients.

      I dont know a physician who hasnt been asked by at least one patient about a specific drug they saw advertised, Lund said.

      Viagra ads

      Some drug ads are more controversial than others. The AIDS Healthcare Foundation (AHF) last year filed a lawsuit against Pfizer Inc., the world's largest pharmaceutical company and manufacturer of impotence drug Viagra, over its marketing tactics and advertising.

      AHF claims that Pfizer's Viagra advertising "has caused an increase in the spread of sexually transmitted diseases including but not limited to HIV/AIDS."

      "Pfizer has engaged in and continues to engage in this conduct despite clear evidence of its illegality and harmful effects," the foundation charged. The lawsuit was filed in Los Angeles Superior Court.



      "Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," said Nielsen....

      Californians Fight Back Against 'Rescinded' Health Coverage

      Class actions against Blue Cross of California heat up


      Want to keep your health insurance in California? Be sure you dont get sick.

      Customers across the state accuse Blue Cross of California and its subsidiary, Blue Cross Life and Health, of canceling their policies as soon as hefty bills start to roll in.

      When Jessica Bath of Morro Bays son Jack was born with a hole in his heart, Blue Cross took a closer look at her medical records and rescinded her coverage.

      Heres how it works: After a consumer applies for health insurance coverage, a company has two years within which it can cancel (rescind) coverage if it believes the applicant has made a false statement on the application or perhaps failed to disclose a medical fact.

      This situation applies to the individual, private insurance market. Policies issued through an employer are not subject to underwriting (background investigation).

      Among Blues shady practices recently uncovered: letters to physicians asking them to double-check health insurance applications for accuracy and report any errors to the company (usual result: pre-existing condition = fast-track to being uninsured.)

      Powerful allies

      Consumers have picked up powerful allies in battling Blue during the past year. Both Blue Cross and Kaiser Permanente were fined by Californias Department of Managed Care for improperly cancelling policies, and the states Department of Insurance is seeking to fine Blue Shield Health and Life Company for $12.6 million.

      More recently, the 35,000-member California Medical Association and the California Hospital Association (representing 450 hospitals) joined pending consumer class actions against Blue, charging unlawful rescission of over 6, 000 policies.

      What does this mean to someone whos suddenly found themselves among the nations 47 million uninsured?

      It's hard to say but the game may be up soon. In a case similar to Jessica Baths, Blue Cross cancelled Raudel and Maria Rodriguezs policy after Raudels medical bills topped $100,000. The Rodriguez family filed a class action, alleging that the company engaged in post claims underwriting, or illegally canceling after the bills got too high.

      In another coup for consumers, both the trial court and the Court of Appeals ruled that consumers cant be forced to waive a jury trial and shoehorned into binding arbitration without a clear and specific warning. Unknown to many consumers, arbitration rulings have several drawbacks: theyre expensive (and consumers must pay half), they dont create legal precedent and they cant be appealed to a higher court.

      LA takes action

      Officials across the state have gotten involved, including Los Angeles City Attorney Rocky Delgadillo, who has sued Blue Cross for fraud and created a Web site, www.protectingtheinsured.org, where doctors and patients can post their own experiences with health insurance problems.

      The Department of Managed Care has ordered 26 of the most outrageous cancellations to be reversed, and promised to investigate all rescissions between 2004 and 2008 by the five largest insurers in the state.

      The five largest companies selling individual policies in California are Anthem Blue Cross, Kaiser Permanente, HealthNet, Inc., Blue Shield of California and PacifiCare of California.

      While there may not yet be an across-the-board solution to the problem, individual consumers are winning some pretty impressive victories.

      Patsy Bates, diagnosed with breast cancer, recently won a $9.4 million judgment against HealthNet, which cancelled her insurance while she underwent chemotherapy; $8 million of that amount was for punitive damages, awarded to punish a defendant for intentionally unlawful conduct.



      Californians Fight Back Against 'Rescinded' Health Coverage...

      Nader Protests Feds' Roof Crush Plan

      Bush 'doesn't give a darn about it'


      Consumer advocates and members of Ralph Nader's presidential campaign rallied outside the Department of Transportation building in Washington, D.C. today to protest a roof crush safety proposal which they say will do little to save lives in automobiles that roll over.

      Although rollovers comprise less than five percent of all crashes, 25 percent of all vehicle fatalities are from rollovers approximately 10,000 every year, according to the campaign website for Ralph Nader, a longtime consumer advocate who is running for president as an independent in 2008.


      Byron Bloch, independent auto safety expert, shows Ralph Nader the two designs Ford uses in some vehicles. One cost $1 more than the other, but is significantly stronger. In the background is Paula Lawlor, director of People Safe in Rollovers and Kevin Moody, whose son died in 2003 when a Ford Explorer rolled over and crushed him.

      The National Highway Traffic Safety Administration (NHTSA), which is part of the Department of Transportation, is expected to update its 36-year-old roof crush standard in July.

      The current standard requires that a vehicle sold in the U.S. have a roof that can withstand 1.5 times the weight of the vehicle without collapsing more than five inches into occupancy space. The test is administered by a static crusher that slowly applies pressure to the corner of a vehicle's roof.

      The new standard is expected to be the same test but requires vehicles' roofs hold 2.5 times the weight of the vehicle. Nader, who was instrumental in creating NHTSA in 1966, said the new standard is still not adequate.

      We are demanding that they issue a standard of at least four times the vehicle weight in a rollover, Nader told ConsumerAffairs.Com during the protest.

      Dynamic tests

      Nader said NHTSA should also perform dynamic rollover tests that more closely replicate the dramatic effects of an actual rollover such as dropping the car on its roof from a certain distance or physically rolling it over.

      NHTSA representatives believe the new proposal, which has been in the making for years, will be adequate.

      We're pretty confident that when the final regulation comes out, it will be certainly a significant improvement over what's on the books now and it will add significant added protection in the event of a rollover, said Rae Tyson, NHTSA spokesman.

      Tyson refused to say why the agency will not use static tests.

      Some foreign manufacturers such as Saab, Volvo and Suburu require that at least some of their models pass a four-times-the-weight static test and numerous dynamic tests.

      American auto companies want a weak standard that will kill more Americans and produce more quadriplegics and paraplegics, Nader said.

      Independent safety experts have speculated for years that it would be very easy and cheap, around $1 to $50, to make American vehicles pass far stricter rollover tests.

      "Easiest fix"

      This is the easiest fix you can imagine, Nader said.

      In one example, Byron Bloch, an independent auto safety expert and consultant, demonstrated today that for about $1, Ford could make a large portion of its fleet much more resistant to rollover crush by using a boxed, closed section above the windshield rather the single sheet of metal the company frequently uses. He brought with him examples of both. The single sheet wobbled when he shook it while the box frame, which he said Ford uses in some Mustangs, held firm.

      As it's written now, the new proposal would also create a Federal preemption that would prevent roof crush victims from seeking justice in state courts. Twenty eight state attorneys general have spoken out against that provision.

      Many employees at NHTSA and within the White House often seek jobs with the auto industry after regulating it. Nader blamed these weak roof crush provisions and others on the close ties regulators have come to enjoy with American automakers.

      It was created to be a tough enforcement agency that saves American lives and prevent injuries and it has become a weak consulting firm to the auto companies, coddling the auto companies instead of caring for the safety of the American people, Nader said.

      Nader ultimately blamed the perceived failures of the agency on President Bush.

      He's always said his main job is the safety of the American people but I guess he can't prove terrorists are behind this roof crush standard so he doesn't give a darn about it, Nader said.

      Also at the protest were representatives of People Safe in Rollovers, a nonprofit that aims to strengthen roof crush standards far beyond what NHTSA is proposing.

      The nonprofit's director, Paula Lawlor, has written legislation that would require vehicles pass a 3.5-times-the-weight static test and make those test results readily available to consumers at the time of sale. It also could mean retrofitting older vehicles to pass her new standard.

      Sen. Mark Pryor (D-Ark), chairman of the Subcommittee of Consumer Affairs, Insurance and Automotive Safety has scheduled a tentative hearing June 4 to discuss Lawlor's bill and the dangers of vehicle rollovers.

      The Committee plans to hear from all stakeholders, including representatives from NHTSA, the automobile industry, auto safety advocates and representation from (a) victims family, Crystal Waitekus, spokeswoman from Pryor's office, wrote in an e-mail.

      ---

      Photo by Joe Enoch

      Nader Protests Feds' Roof Crush Plan...

      Honda Recalls ATVs

      May 8, 2008
      American Honda Motor Co. is recalling about 1,400 model year 2008 Honda TRX500 ATVs. The electric power steering shaft of the recalled ATVs could break unexpectedly, resulting in the riders losing steering control.

      This recall involves Model Year 2008 Honda TRX500 ATVs equipped with electric power steering, also known as the Honda FourTrax Foreman 4X4 with electric power steering. The adult-size ATVs are designed for use by riders age 16 and older. The ATVs are available in red, black, olive, white, and camouflage. Honda and wing logo are printed on the fuel tank and TRX500 is printed on the side panel just below the seat.

      The ATVs were sold by Honda ATV dealers nationwide from October 2007 through March 2008 for between $6,850 and $7,400. They were made in the United States.

      Consumers should stop using these recalled ATVs immediately and contact any Honda ATV dealer to make an appointment for a free repair. Registered owners of the recalled ATVs have been sent direct notices.

      For additional information, consumers can contact Honda toll-free at (866) 784-1870 between 8:30 a.m. and 5 p.m. PT Monday through Friday, or visit the companys website at www.powersports.honda.com.

      The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

      Honda Recalls ATVs...

      Protections Increased for Air Travelers with Disabilities

      But travelers complain existing rules are often ignored

      Travelers with disabilities will be getting new protections against discrimination when they fly on a foreign airline flight that begins or ends in the United States, as well as on any flight operated by a U.S. carrier anywhere in the world.

      That's because the U.S. Department of Transportation (DOT) has strengthened its existing regulation implementing the Air Carrier Access Act (ACAA) and extended it to foreign airlines.

      Some consumers, however, say that existing rules are poorly enforced and often of little benefit to disabled travelers.

      "I wrote Northwest Airlines customer services about its failure to address my needs as a disabled customer and the fact that the assigned seats for my flight from PDX to BKK, Airbus 330, in no way addressed my need to be able to partly extend my leg," Guy of Lincoln City, OR, complained to ConsumerAffairs.com.

      "When I got on the flight the assigned disability seat had less legroom then the standard seat," he said. "I spent the whole flight in extreme pain, hip and both knees unable to even stand up during the flight to relieve the pressure."

      DOT's existing rules provide that airlines must provide assistance with boarding, deplaning and making connections. Assistance within the cabin is also required.

      But Kenneth of Los Banos, CA, complained that he was restricted to his seat when he flew Southwest Airlines from San Jose to Buffalo, NY.

      "The passengers were not able to leave the aircraft at each stop unless they were arriving at their destinations, since the layover time averaged 15 minutes at each stop. In flight, we were not allowed to stand in line to use the restrooms, and since I am disabled, this made it impossible for me to use them," he said.

      "I travel with a wheelchair and crutches, and for me to try to use the restroom or even move around the cabin is pure torture!" he said.

      Pam of Cincinnati, who has limited mobility, had trouble boarding her US Airways flight to Philadelphia. She, like many passengers who have complained to ConsumerAffairs.com, said she alerted the airline in advance that she needed wheelchair assistance but found no help when she got to the airport.

      "Other passengers get very mad at me because I am slow and unsteady" when boarding, she said. "When we got to Philly, there was no jetway. Stairs are extremely difficult for me. No one offered to assist me down the stairs or with my bags. ... There was NO wheelchair for me in Philly at the gate, and no gate agent."

      Oxygen

      The new rule also will make it easier for passengers to use medical oxygen during flights by requiring airlines to allow the use in the passenger cabin of portable oxygen concentrators that meet applicable safety, security and hazardous materials requirements for safe use aboard aircraft, DOT said.

      DOT said it will seek further comment on whether airlines should be required to provide medical oxygen to passengers upon request. In addition, the department is studying subjects such as accessibility of airline web sites, automated ticketing kiosks, and in-flight entertainment systems.

      The new rule also will provide greater accommodations for passengers with hearing impairments by requiring airlines to include easy-to-read captions for the hearing-impaired in its safety and informational videos.

      Airlines must promptly provide the same information to hearing- and vision-impaired passengers that it provides to other passengers in airport terminals or on the aircraft -- such as information on boarding, flight delays, schedule changes, weather conditions at the flights destination, connecting gate assignments, checking and claiming of baggage, and emergencies.

      The rule does not specify how carriers should make this information available to passengers who are deaf or hard of hearing.

      The new rule will be effective in one year to give carriers enough time to begin implementing its provisions, DOT said.



      Protections Increased for Air Travelers with Disabilities...

      Phishing Scammers Get More Creative

      Coulee Dam scammers try to leave no trace of their activities

      Who hasn't received a spam email saying their credit or debit card has been deactivated and the consumer needs to call the bank to straighten things out? Usually, that entails providing account numbers, user names and passwords, and other sensitive information.

      And of course, it's not the bank that's requesting the information, but a criminal.

      In the Pacific Northwest, Coulee Dam Federal Credit Union is the target of a phishing scam that attempts to disarm savvy consumers with a little honesty. The spam email informs the recipient their debit card has been deactivated and that they need to take action.

      If the consumer doesn't have a CDFCU account, they are likely to see the email for what it is. But if you're one of the credit union's 11,980 members, you might be fooled. The scammer even includes a link in the email not to some bogus, look-alike site but to CDFCU's actual Web site.

      To straighten everything out, the consumer is told to call a toll-free number. When you call the toll free number, you hear a generic message saying to leave a message at the tone. There is no request for you to provide sensitive information.

      That may be because law enforcement can use such recordings in court as evidence of a fraud if the scammer is ever apprehended. The scammer, instead, needs a way to speak directly with the victim without the danger of being traced.

      They do that by simply asking the caller to leave a message. Someone sincerely concerned about their debit card might leave their phone number. If they do, the scammer can call them back, using an untraceable phone, and obtain the sensitive information that could then be used to steal the victim's identity and clean our their bank account.

      A spokeswoman for CDFCU told ConsumerAffairs.com that the credit union is aware of the scam and is currently working with investigators.

      In the meantime, consumers should take the advice of security experts who say never to respond directly to any email that appears to request any sensitive information. If you're not sure, they say, call the bank by looking up the number in the telephone book, not by calling a number in an email.

      More Scam Alerts ...

      Who hasn't received a spam email saying their credit or debit card has been deactivated and the consumer needs to call the bank to straighten things out?...

      Ortho-Evra Patch Should Be Withdrawn: Public Citizen

      Contraceptive patch said to expose women to dangerous estrogen levels

      The contraceptive patch Ortho-Evra exposes women to dangerous levels of the hormone estrogen, posing a possible two-fold increase in the risk of blood clots, and should be removed from the market within six months, Public Citizen told the Food and Drug Administration (FDA) in a petition.

      Ongoing litigation has recently released unpublished studies that confirm the increased estrogen content of the patch, the organization said.

      Evidence compiled by Public Citizens Health Research Group reveals that, compared to standard oral contraceptives, Ortho-Evra exposes women to:

      • More estrogen and a greater range of estrogen levels;

      • A possible two-fold increase in the risk of blood clots;

      • Increased painful side effects such as breast discomfort, severe menstrual pain, nausea and vomiting;

      • An increased likelihood of discontinued contraceptive use; and

      • No improvement in contraceptive outcomes.

      Because the patch is still superior to no contraception at all, withdrawal of any contraceptive from the market carries the risk that some users will not immediately replace their contraception with a method that is as effective as the banned product.

      Public Citizen is requesting a six-month transition period in which Ortho-Evra will be available for refill prescriptions to allow women time to meet with their healthcare provider and seek a safer, alternative contraceptive method.

      Seven days

      Ortho-Evra patches are designed to be worn on the skin for seven consecutive days before removal. Three consecutive patches are worn followed by a patch-free week.

      When Johnson & Johnson received FDA approval in November 2001 for marketing the patch, the company claimed that its product would have two key advantages over existing oral contraceptives:

      1) A constant delivery of hormones instead of the ups and downs associated with pill use, and

      2) improvements in compliance compared to the daily dosing regimen of oral contraceptives.

      However, evidence soon emerged that these theoretical benefits are outweighed by side effects from receiving high and variable levels of hormone exposure.

      A post-market study was the basis for a 2005 label change explaining that overall exposure to estrogen from the Ortho-Evra patch was 55 to 60 percent higher from the patch than a standard, 35 microgram (mcg) estrogen oral contraceptive.

      Comparison studies have also shown that the amount of absorbed estrogen varied 1.2 to 3.5 times as much for women who used the patch than women who used oral contraceptives.

      Had Ortho-Evra been designed as a pill, it is unlikely to have been approved because of its increased estrogen content, said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.

      In 1988, the FDA requested the withdrawal of all oral contraceptives with estrogen levels greater than 50 mcg because of the risk of blood clots and lack of additional contraceptive efficacy. The Ortho-Evra patch contains estrogen equivalent on average to a 56 mcg pill.

      Label changed

      The Ortho-Evra label was changed again in 2006 and 2008 to include findings from studies that revealed an up to two-fold increase in the risk of blood clots in women using the patch compared to standard oral contraceptives.

      Further, side effects (such as breast discomfort, painful periods, nausea and vomiting) and discontinuation (stopping the contraceptive entirely) due to side effects were more common among women who used the patch compared to those who used pills.

      Finally, Johnson & Johnson advertises that women who use the patch are more likely to use it correctly than women who use pills. Yet there are no measurable differences in pregnancy outcomes. In other words, the patch does not provide any additional benefit that would outweigh the risks of high estrogen, Public Citizen said.

      Although demand for the patch has dropped dramatically in the past several years, from more than 9.9 million filled prescriptions in 2004 to 2.7 million filled prescriptions in 2007 (a decline of 73 percent), Ortho-Evra remains among the top 200 brand-name drugs by sales and prescriptions in the United States and is thus still a danger to large numbers of women in this country.

      Women deserve a level of risk at least comparable to or less than the pill for their hormonal contraceptive, Wolfe said. The absence of any evidence of a unique benefit combined with the considerable safety problems of high-dose, variable estrogen exposure in Ortho-Evra tips the balance of risks and benefits against its availability as a contraceptive.



      Ortho-Evra Patch Should Be Withdrawn: Public Citizen...

      Facebook Agrees to Upgrade Safety Measures

      States pressure social site to increase protections for minors

      Under pressure from the attorneys general of 50 states and the District of Columbia, Facebook has agreed to make key changes to its social networking site that will better protect children from predators and inappropriate content.

      Since 2006, the state attorneys general have sought to make social networking Web sites safer.

      As part of the agreement announced today, Facebook will:

      • Provide automatic safety messages when a child is in danger of giving personal information to an unknown adult,

      • Restrict the ability of users to change their listed ages,

      • Act more aggressively to remove inappropriate content and groups from the site, and

      • Require third party vendors to adhere to Facebooks safety and privacy guidelines.

      Facebook also has agreed to maintain a list of pornographic Web sites and regularly cut any links to such sites. The company will remove groups for incest, pedophilia, cyberbullying and other violations of the sites terms of services, as well as expel from the site individual violators of those terms.

      The social network site also has agreed to more prominently display safety tips to its users, require users under age 18 to affirm they have read Facebooks safety tips when they register and regularly review models for abuse reporting.

      Following the discovery of more than 1,800 Illinois sex offenders on MySpace, a Madigan subpoena to Facebook discovered 123 of those MySpace Illinois sex offenders had created profiles on Facebook, as well. Facebook has since removed those profiles.

      Key principles

      Todays agreement with Facebook includes a Joint Statement on Key Principles of Social Networking Sites Safety developed by the attorneys general similar to those agreed to by MySpace. The principles fall into four categories:

      • Creating an Online Safety Task Force

      • Developing Design and Functionality Changes to Protect

      • Children on Facebook

      • Developing Education Materials and Tools for Parents,

      • Educators and Children

      • Cooperating with Law Enforcement

      As with MySpace, I am concerned that young people communicating through Facebook run into risks of having contact with sexual predators roaming the Internet looking to meet children, teens and others, said Madigan. Many Facebook users are children who are simply too trusting and sometimes too free with the information they make available on their Facebook pages.

      Today's agreement is similar to one that MySpace reached in January with 49 states and the District of Columbia. MySpace agreed to head a task force, which Facebook has joined, focused on developing technology to verify the age and identity of social networking site users. The task force will report back to the attorneys general every three months and issue a formal report with findings and recommendations at the end of 2008.

      Facebook Agrees to Upgrade Safety Measures...

      Chrysler Expands Jeep Stalling Recall

      Transmission software will be reprogrammed

      Chrysler is expanding the recall of Jeep Commander SUVs to repair engine stalling that has endangered scores of Jeep owners.

      The National Highway Traffic Safety Administration (NHTSA) reported that the automaker has now recalled 24,461 2006 Jeep Commanders to reprogram automatic transmission software in Jeeps equipped with the 4.7 liter engine.

      NHTSA warned Commander owners that the software glitch could cause a crash without warning.

      NHTSA opened an investigation of the 2007 Jeep Wrangler SUV last year following at least 53 reports of the engine stalling at highway speeds.

      That investigation involved 35,000 vehicles, according to NHTSA.

      At the time, NHTSA reported that the agency had received complaints of engine stalls at highway speeds that included 12 cases with a loss of electrical power and lighting.

      The latest Jeep Commander recall involves computer software in the automatic transmission control module of the 2006 Commander. Jeep dealers will reprogram the software in 2006 Jeep Commanders built before January 11, 2006.

      In a limited action, Chrysler recalled 1,338 of the 2008 Jeep Grand Cherokee and Commander earlier this year to repair a stalling problem in the vehicles. In that recall, NHTSA reported that the the front control module may have been incorrectly manufactured," and could cause the engine to stall while driving or not start.

      Jeep owners describe the stalling condition as frightening. On May 6, a Galveston, Indiana woman struggled with a stalled Jeep.

      Everything just completely shuts down and I am unable to steer and have to restart the engine, Cathleen wrote ConsumersAffairs.Com. This has happened 3 to 4 times now and the dealer says there is nothing they can find wrong with my vehicle. It happened again today while in a parking lot.

      Consumers reported that in many cases Jeep dealers are unable to fix the stalling.

      I have had my Jeep in and out of the shop in regards to it stalling all of a sudden, a Wisconsin woman reported to ConsumerAffairs.Com. Each possibility proposed to me is not a sure fix and is very expensive, she said.

      In San Francisco, a ConsumersAffairs.Com reader said the stalling problem behind two Chrysler recalls is not limited to the new Commander. I have a 1997 Jeep Laredo that I purchased over 2 years ago from a used car dealer. The stalling problem started around January 2008, she said. I was going 60 mph on the highway and it just died.

      Jeep owners can contact Chrysler about the stalling problems at 1-800-853-1403 or NHTSA at 1-888-327-4236 (TTY 1-800-424-9153).

      NHTSA reported that the automaker has now recalled 24,461 2006 Jeep Commanders to reprogram automatic transmission software in Jeeps equipped with the 4.7...

      Treacherous Treads Still Taking Lives

      Firestone tires on a Ford Explorer can still be a lethal combination


      See CBS4's full report

      ---
      More about the Firestone recall
      More about rollovers

      It's been eight years since more than eight million Firestone AT, ATX and Wilderness tires were recalled but the tires are still claiming victims, an investigation by Miami's CBS4 News has found.

      Among the latest are two Miami-area men, Jason Crespin and Steven Tarafa. They died on Feb. 18 when Jason's 1999 Ford Explorer swerved out of control and hit a tree, the Florida Highway Patrol said.

      Tarafa's mother, Denise Sosa, talked with CBS4 Consumer Investigator Al Sunshine about the last time she saw her son alive, minutes before he left on a short business trip to North Florida.

      "He hugged me and he kissed me and he said I'll see you next week and that was it. I never got to see him again," she said.

      The cause, according to the state's accident report? The Firestone Wilderness-AT tire on Jason's 1999 Ford Explorer came apart while they were driving from Tallhassee to Jacksonville.

      The accident report includes the notation "Vehicle Defect: The left rear tire of vehicle 1's tread (cap) separated from the main body of the tire."

      Both families are now suing Ford, Firestone and the Miami used car dealer that sold Jason the old Explorer just three weeks before the accident.

      According to the lawsuits, the nine-year-old tire is believed to be the original spare that came on the the old Explorer.

      Post-recall

      The accident awakens the long-smoldering debate between Ford and Firestone. Each blamed the other for the rash of accidents involving the tire, most of them on Ford Explorers.

      Firestone finally agreed to recall millions of the tires but continued to insist that the accidents were at least partly caused by faulty design on the Explorers. It also blamed consumers for not maintaining proper pressure in the tires.

      But the argument is moot in the case of Jason and Steven. That's because the tire on their Explorer was made after the cutoff date of the Firestone recall.

      Perhaps so, but Miami attorney Mike Eidson says the tire failed exactly the same way the earlier Firestones did. The entire top tread came off in one big piece.

      "They all look like this," Eidson said. "They all end up with this little shoulder piece and then the treads gone" showing how all that was left of the tire was the so-called steel-belted casing and the two sidewalls.

      Both families say they don't understand why state and federal auto safety agencies are not doing more to warn consumers that old, recalled tires could still be on pre-owned Ford Explorers, Sunshine reported.

      Under Florida law there's no formal requirement that used-car dealers have to make sure the vehicles they sell don't have recalled tires on them.

      "You're going to see more and more people die every year as these tires get older as they remain on these cars That's what's going to happen. Each one has the potential to be a ticking time bomb, like this one. They're dangerous," Eidson said.

      The feds told CBS4 they believe more than 90% of Firestones' recalled tires are now off the market. But critics say that means hundreds of thousands more could still be in old Ford Explorers as spare tires their new owners may not know about.

      Companies respond

      Ford says it recommends replacing tires after six years, including spares. A spokesman said the company offers its sympathy to the Florida families.

      Firestone says its campaign pulled 95 percent of the recalled tires off the market and was one of the most effectively administered product safety campaigns in history.

      If customers have questions about the safety of their tires, they should check with their nearest Ford or Firestone dealer for a free safety check, both companies said.

      CBS4's Sunshine added this safety note: "As I've been reporting for 8 years now, SUV owners especially need to check your tire pressure at least once a month, don't overload your vehicle beyond its posted weight limits and maintain the proper speed limit."

      "As we approach the summer driving season with our crowded, hot highways, tire safety should be an even more important concern for all of us and our families."

      Treacherous Treads Still Taking Lives...