As we were just saying yesterday, buying health insurance can be a frightening and baffling experience, especially for consumers who have to shop on their own instead of getting coverage through an employer group plan.

But starting later this year, every health plan is going to have to explain its benefits in a standard, consumer-friendly information label that will spell out exactly what’s covered, what is not, and how much of the bill you’ll have to pay. And you won’t have to wait until after you’ve signed up for the plan to see it.

This label is required by one of the many consumer-friendly provisions tucked away in the Affordable Care Act (aka Obamacare). The final rules on what the label will look like, and who has to provide it, issued today by the U.S. Department of Health and Human Services, survived intense efforts by large employers and the insurance industry to water them down, according to DeAnn Friedholm, director of health reform for Consumers Union, the advocacy arm of Consumer Reports.

“The final label is a huge win for consumers,” Friedholm said. “Insurers will no longer be able to hide the costly parts of their plans in fine print scattered around documents hundreds of pages long.”

For instance, the new label (here’s a sample) will require plans to spell out exactly what does and doesn’t apply towards the deductible, something that, trust us, can be almost impossible to figure out today. If the plan doesn’t cover something important, like drugs or maternity care, you’ll be able to see that easily, too.

The label will be required for any plan that goes into effect after Sept. 23, 2012, in time to help employees with fall open enrollment choose their coverage for next year.

People buying in the individual market will also be able to see the label when they look up plans available in their geographic region on the invaluable insurance finder tool on Healthcare.gov, HHS’s consumer site. They’ll also get a fresh copy in advance of their annual renewal date, and can request a copy at any time.

The label will not, however, be available to people buying any kind of Medicare plan, including private Medicare Advantage or Medicare supplement (Medigap) plans, which aren’t subject to this portion of the health reform law.

One of our quibbles with the new rules has to do with a part of the label that our own consumer testing showed was the most helpful. These are the “coverage scenarios,” which show what the plan would pay for care of several standardized health conditions. The original version of the form had three such scenarios: having a baby, treating type 2 diabetes for a year, and treating breast cancer.

“These scenarios are great because they do the math for you, so you can instantly see whether one plan’s coverage will be skimpier than another one,” Friedholm said.

The final rule omitted the breast cancer example, which is too bad because it was the most costly treatment and thus best able to highlight plans with big gaps. HHS officials, however, said they were planning to identify some other costly standard scenarios to add later.

Medications called proton pump inhibitors (PPIs) might increase the risk of a type of chronic diarrhea that can lead to severe intestinal problems and, in rare cases, death, the Food and Drug Administration said Wednesday. These drugs—which include Nexium, Prevacid, and Prilosec—are used to treat heartburn and gastroesophogeal reflux disease (GERD).

The FDA's alert is based on reports it has received as well as 23 studies that overall found that people who took a PPI were up to 2.75 times more likely than those who didn't to develop Clostridium difficile-associated diarrhea (CDAD)—which can cause abdominal pain, fever, and more serious problems. Some people went on to need surgical removal of part of the colon and there were rare reports of deaths. The FDA said it's unclear whether higher doses or longer use of PPIs increase the risk.

The warning applies to both over-the-counter and prescription PPIs including dexlansoprazole (Dexilant),esomeprazole (Nexium), esomeprazole combined with naproxen (Vimovo), lansoprazole (Prevacid and Prevacid 24hr, and generic), omeprazole (Prilosec, Prilosec OTC, and generic), omeprazole combined with sodium bicarbonate (Zegerid and Zegerid OTC), pantoprazole (Protonix), and rabeprazole (AcipHex).

The FDA is also looking into whether there's a higher incidence of the condition in people who take another type of heartburn drug called H2 receptor blockers, which include cimetidine (Tagamet OTC and generic), famotidine (Pepcid AC and generic), nizatidine (Axid AR) and generic, and ranitidine (Zantac 75, Zantac 150, and generic).

Bottom line: If you need a proton pump inhibitor to treat GERD or frequent heartburn, use the lowest dose and take it for as short a time as possible to help reduce your risk of Clostridium difficile-associated disease. If you develop diarrhea that does not improve while taking a PPI, contact your doctor because this can be a sign of the disease.

Read our Best Buy Drugs report on proton pump inhibitors.

Source
Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs) [FDA]

A House bill introduced today aims to limit levels of arsenic and lead in fruit juices. When the bill was announced, the sponsors cited Consumer Reports’ investigation into the issue, which found high levels of arsenic and lead in the juices we tested.

While federal limits exist for arsenic and lead levels allowed in bottled and public drinking water, there are no limits defined for juices, a mainstay of many children’s diets, putting them at unnecessary risk for serious health problems, including several forms of cancer.

The proposed Apple-Juice Act of 2012 was introduced by Congressman Frank Pallone Jr., (D-NJ) and Congresswoman Rosa DeLauro (D-CT), and calls on the Food and Drug Administration to establish standards for arsenic and lead in fruit juices in two years time.

For our investigative report, we tested 88 samples of apple juice and grape juice for lead and arsenic. We found that roughly 10 percent of the samples, from five brands, had total arsenic levels that exceeded federal drinking-water standards of 10 parts per billion (ppb) and 25 percent of the samples had lead levels higher than the Food and Drug Administration’s (FDA) bottled-water limit of 5 ppb. Most of the arsenic detected in Consumer Reports’ tests was a type known as inorganic, a human carcinogen.

Based on our juice test results and other evidence from our investigation, Consumers Union, the advocacy arm of Consumer Reports, had previously urged the FDA to set a standard of 3 ppb for total arsenic and 5 ppb for lead in apple and grape juice. Consumers Union supports the proposed bill. “This bill will go a long way toward protecting the public, especially children, from exposure to these toxins,” said Ami Gadhia, Senior Policy Counsel for Consumers Union.

For more information you can see our full report Arsenic in your juice: How much is too much? Federal limits don’t exist, plus you can download a pdf of our complete test results, as well as watch our video below.

Controversy over arsenic in apple juice made headlines as the 2011 school year began when Mehmet Oz, M.D., host of “The Dr. Oz Show,” told viewers that tests he’d commissioned found 10 of three dozen apple-juice samples with total arsenic levels exceeding 10 ppb. Around that time, the FDA reassured consumers about the safety of apple juice, claiming that most arsenic in juices and other foods is of the organic type and “essentially harmless.”

The FDA has since revised information on its website to include the following: “Some scientific studies have shown that two forms of organic arsenic found in apple juice could also be harmful, and because of this, the FDA counts these two forms of organic arsenic in with the overall content for inorganic arsenic.”

Previously:
Consumer Reports tests juices for arsenic and lead
Consumer Reports discloses additional data from its arsenic tests

Consumers Union: Pallone Bill to Limit Arsenic, Lead in Fruit Juices Helps Protect Public from Toxins [Consumers Union]

Q. I just went on disability and am receiving COBRA through my former employer. But I’m about to move from Hawaii to Florida and will lose my COBRA. The only option I found is a United Health Group indemnity plan for just under $500 a month. It covers 50 percent to 70 percent of office and hospital visits, plus cash, including Rx, dental, and vision. What should I do?

A. This question arrived while I was researching and writing our new report on junk health insurance. It was fairly bristling with the red flags that I was discovering in my reporting, so I replied right away. It turns out that the man who wrote it, Ted Tenenbaum, was just about to buy one of the very plans we warn against. He agreed to share the details of his story in the article.

To spare you the suspense, I’ll tell you that pretty much everything he believed about his situation turned out to be wrong, including the name of the insurance company. UnitedHealth Group, the parent company of UnitedHealthcare, the nation’s largest commercial health insurance company, had nothing to do with his plan. (The name on his card was the similar-sounding “USHealth Group.”) Furthermore, it didn’t cover 50 percent to 70 percent of the things he thought it did. Instead, it was a fixed-benefit indemnity plan that would have bankrupted him if he ever experienced an expensive illness or injury.

Tenenbaum went astray the way many consumers do: by typing “affordable health care” into a search engine, filling out a form that promised an instant quote, and being inundated with sales calls that left him thoroughly confused and misled.

In that, he has plenty of company. Lynn Quincy, a health care policy analyst in our Washington, D.C., office, has been researching the question of “consumer insurance literacy” and has found that the vast majority of us are at about a kindergarten level.

When faced with choosing health insurance, she said, “people close their eyes and guess, They turn to people they hope know more than they do, like a broker, or neighbor, or their mother. They don’t understand how insurance works. The underlying product is complex. Tools to convey the information aren’t very good. And they dread the exercise.”

If you are buying health insurance on your own, check out our tips on how to buy insurance safely and how to recognize a junk plan.

As for Ted Tenenbaum, it turned out that he could keep his good COBRA plan when he moved after all. And it was cheaper than the indemnity plan.

Got a question for me? Ask it here.

The average person consumes about 3,300 milligrams of sodium per day, not including any salt added at the table, which is more than twice the recommended limit for about half of Americans, according to a report from the Centers for Disease Control and Prevention.

Most of that sodium comes from common restaurant or grocery store items. The CDC's latest Vital Signs report found that 65 percent of sodium comes from grocery store foods, while 25 percent comes from restaurants meals.

10 foods responsible for more than 40 percent of your sodium intake:

• Bread and rolls
  
• Cold cuts and cured meats
  
• Pizza
  
• Poultry
  
• Soups
  
• Sandwiches
  
• Cheese
  
• Pasta mixed dishes
  
• Meat mixed dishes
  
• Savory snacks.

Excessive sodium consumption raises blood pressure, which is a major risk factor for heart disease and stroke, the nation's first and fourth leading causes of death. Reducing the sodium content of the 10 leading sodium sources by 25 percent would lower total dietary sodium by more than 10 percent, and could play a role in preventing up to an estimated 28,000 deaths per year, according to the CDC.

We recently reported about how nearly 7,000 consumers joined Consumers Union, the policy and advocacy arm of Consumer Reports, in a petition supporting regulatory efforts to set national, industry-wide targets to reduce sodium in processed and restaurant foods.

"Many American consumers are seeking a sensible solution to the growing levels of sodium in processed and restaurant foods," said Ioana Rusu, regulatory counsel for Consumers Union. "Unfortunately, the answer is not simply to put down the saltshaker, since an overwhelming majority of sodium intake comes from processed, pre-packaged foods."

Vital Signs: Food Categories Contributing the Most to Sodium Consumption — United States, 2007-2008 [CDC]

Seafood Solutions, a California corporation, was sentenced in federal court to pay $1 million in fines and community service payments for its role in the false labeling of frozen fish fillets, the U.S. Department of Justice reported.

The corporation was fined $700,000 and ordered to make a community service donation of $300,000 to the National Fish and Wildlife Foundation, as well as ordered to forfeit all remaining inventory of falsely labeled fish, among other stipulations of the ruling.

In our own investigative report about mislabeled seafood, we found that more than one-fifth of 190 pieces of seafood we bought at retail stores and restaurants in New York, New Jersey, and Connecticut were mislabeled, incompletely labeled, or misidentified by employees.

The mislabeled fish at issue in the Seafood Solutions case was Pangasius hypophthalmus, a species in the catfish family that was misleadingly labeled as “Paradise Grouper” and “Falcon Baie Grouper.”

In 2004, Seafood Solutions began selling a fish it declared to customs as “ponga.” The fish being imported was actually Pangasius hypophthalmus. The fish was then sold under the brand names, and in boxes labeled in part as, “Paradise Grouper” and “Falcon Baie Grouper.”

The case was investigated by the National Oceanic and Atmospheric Administration, Office of Law Enforcement and the Department of Homeland Security, Immigration and Customs Enforcement. The case is being prosecuted by the Environmental Crimes Section of the Department of Justice and the U.S. Attorney’s Office for the Central District of California.

For more about how mislabeled seafood—whether deliberate or not—hurts consumers, you can see our full report Mystery fish - The label said red snapper, the lab said baloney, and check out our video below.

California Seafood Corporation Sentenced to Pay $1 Million for False Labeling of Seafood Products [DOJ]

Like to snack at the movies? That tub of popcorn and large soda can amount to almost a full day’s calories, two days’ worth of fat and a cup of sugars.

We tested the largest sizes available of popcorn (with and without butter-flavored sauce), cheese nachos, pretzel pieces with cheese, and Coke or Pepsi at three of the nation’s biggest movie-theater chains: AMC, National Amusements, and Regal.

Here are some of our findings, including some nutrition nightmares for the largest possible sizes of some classic movie theater snacks.

Now compare those scary nutrition facts to the recommended daily amounts for the following:

• Calories: 2,000
  
• Fat: 65 grams
  
• Sodium: Less than 2,300 milligrams
  
• Sugars: There's no recommended amount, but the American Hearth Association suggests a limit of about 6 teaspoons daily fro women and 9 for men.

So it turns out that a large tub of buttered popcorn and a large Coke can supply all the calories you need to eat in a day.

For our snack-by-snack summary and other helpful tips for how best to resist a snack attack at the movies see our full report Movie-theater food: A scary story, as well as our video below.

As Congress debates whether to reauthorize a statute governing medical devices, Consumers Union, the advocacy arm of Consumer Reports is stepping up its campaign to strengthen the law.

Consumers Union wants Congress to require more rigorous testing before medical implants go to market, and establish a better monitoring system, including a national system of notificaiton for when safety problems arise.

Medical devices include every-day items such as eyeglasses and contact lenses, as well as permanently implanted devices like artificial hip joints, surgical mesh, and cardiovascular stents, which can cause serious harm if they break, leak, stop functioning or disintegrate. Even low-risk devices, like contact lens solution and alcohol swabs have recently caused patients harm that could have been prevented, Consumers Union reports.

Unlike prescription drugs, more than 90 percent of medical devices do not require proof that they have been tested and found safe before the Food and Drug Administration clears them for distribution or sale. Each year, about 700 different medical devices are recalled, and in 2009, the FDA received reports of almost 5,000 deaths associated with medical devices.

Lisa McGiffert, director of Consumers Union’s Safe Patient Project said in a statement that most Americans would be surprised to learn of the lax oversight of medical implants.

Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.

This week, Consumers Union is bringing eight patient safety activists to meet with lawmakers in Congress and press for improvements in the Medical Device User Fee Act. For more on the reforms Consumers Union is urging Congress to adopt, see the Safe Patient Project’s Improve the Safety of Medical Devices fact sheet.

Previously: Lax oversight of medical devices puts patients at risk, Consumers Union says

Safe Patient Project: Improve the safety of medical devices and to save lives [Consumers Union]

This week in the Annals of Internal Medicine, the Centers for Disease Control and Prevention recommended that all boys 11 and 12 years old should be vaccinated against human papillomavirus (HPV) and that boys ages 13 to 21 receive “catch up” vaccinations if they haven’t already been vaccinated. This follows an action last fall when an advisory committee with the CDC recommended that 11- and 12-year-old boys receive a routine vaccine.

Health authorities are recommending that all boys be routinely vaccinated against HPV, which is widely linked to cervical cancer and genital warts. At least 50 percent of sexually active men and women get it at some point in their lives. About 20 million Americans are currently infected.

It’s well known that HPV spreads through genital contact, increasing the risk of genital warts and several cancers, including those of the cervix, penis, and anus. The virus can also be transmitted through oral sex, the type of transmission that’s linked to oral cancers.

As Consumer Reports Medical Advisor Orly Avitzur, M.D., points out, the idea of vaccinating children against something transmitted through sexual contact is controversial. "But it’s the best weapon we have at this time against HPV-related cancers," she writes in a column this month. "And clinical trials have found that the vaccine is generally well tolerated and at least as safe as other routinely recommended vaccines."

For more about what you can do, as well as additional information about HPV, read How can you get HPV?

PREVIOUSLY:
Cancer prevention for girls and boys: the HPV vaccine

Recommended Adult Immunization Schedule: United States, 2012 [Annals of Internal Medicine]
New Vaccine Recommendations for Boys and Diabetics [The New York Times]

You might think that doctors, nurses, and other hospital staff would be among the first to get vaccinated against the flu. But too many don’t, even though hospitals can be breeding grounds for the virus and patients there are especially vulnerable to it, according to a report released today by the nonprofit National Business Group on Health. To counter that problem, a coalition of groups led by the NBGH, including the American Hospital Association and supported by Consumers Union, have started an initiative to increase flu-vaccination rates among hospital staff.

Getting the flu shot is important for everyone, since the disease leads to hundreds of thousands of hospitalizations each year and, in some years, tens of thousands of deaths. But it’s especially important for hospital workers, for several reasons.

First, health-care workers are more likely to be exposed to the flu, since many patients bring the virus with them to the hospital or doctor’s office. And if health-care workers do get infected, they’re likely to pass the disease along to their patients, many of whom are especially susceptible to it and its complications. Finally, if doctors or nurses get sick with the flu, they might not be able to provide needed care to their patients, which could be a particular problem during a flu outbreak.

To prevent those problems, expert guidelines from the American Hospital Association and several medical societies have said that all health-care workers should either be vaccinated or take other steps to prevent the spread of infection by, for example, wearing a mask during flu season. And starting next year, new rules will require that all hospitals tell the Centers for Disease Control and Prevention what percentage of their health-care workers have been vaccinated against the flu.

Research suggests that such steps can help prevent the spread of the flu, and save lives. One study concluded that vaccinating the entire staff would prevent about 60 percent of all flu infections among patients. And two randomized trials found that vaccinating health-care workers cut the mortality rate in nursing homes by 44 percent.

But other research, including some conducted by Consumers Union’s Safe Patient Project, suggests that many health-care providers still don’t get vaccinated. A 2010 study by the group, which aims to prevent harm in hospitals, found that two of three reporting California hospitals failed to meet the target of having at least 60 percent of its staff vaccinated against the flu. And many failed to report despite a California law requiring them to do so. Updated results for 2010 and 2011 show that while more California hospitals are reporting, there’s been little improvement in vaccination rates.

Some health-care workers have complained that mandatory vaccination undermines their privacy and individual rights. But patients expect health-care workers to take reasonable steps to protect them from disease, and the flu vaccine seems a very low risk preventive step to take.

As a recent letter in the British Medical Journal says:

Doctors and other health-care providers have an ethical obligation to make decisions and take actions that protect patients from preventable harm. Many patients are highly vulnerable to flu, so choosing not to be vaccinated is choosing to do harm—a choice that has no place in health care.

Infections naturally find the most effective way to survive and spread. In the case of flu, our health-care system has made that too easy.

See our advice on the flu shot, as well as preventing and treating the flu. Also see our tips on how to stay safe in the hospital.

Sources
Hospitals Should Require Flu Vaccination for all Personnel to Protect Patients’ Health and Their Own Health [National Business Group on Health]
Spreading Germs: Low Rates of Flu Vaccination Among California Healthcare Workers Put Patients at Risk [Consumers Union]

I love spicy food. Whether it’s Carribbean, southwestern U.S. or southeastern Asian cuisine, turn up the heat and you get my attention. So when I see headlines connecting heat with weight loss, my curiosity gets piqued.

A recent review in the research journal Chemical Senses looked at studies designed to answer the question of whether capsaicin, the heat-causing chemical found in hot peppers, is effective in helping people either suppress appetite or lose weight. In some studies, people were fed food spiked with capsaicin; in others, they took the chemical in pill form. Yet other studies tested capsiate, a chemical cousin that comes from sweet peppers and doesn’t have the “burn” of capsaicin, so might be more palatable to people that associate “heat” with “heartburn” and other problems.

So, did the use of hot or sweet peppers help? The answer was a resounding “maybe.” After analyzing all those studies, the Purdue University researchers concluded that there was some evidence for a possible connection between capsaicin/capsiate and a mild effects on weight management.

In my book, “mild” is an understatement. Adding a palatable level of spiciness might allow an average weight, middle-aged man to lose a little over a pound over 6.5 years. That’s not a pound a year- that’s a pound total over six and a half years. If the same man ingested it in pill form (so the dose could be higher), he might be able to lose just under six pounds over 8.5 years.

I have to say, this research did little to start a fire in my belly. Especially when they went on to say that they weren’t sure about the long-term effects, as people may adapt to the capsaicin over time.

Does that mean I’m no longer pining for peppers? Hardly. I’d like to believe that some day someone could show a stronger weight management benefit for the hot stuff. In the mean time, I’ll be thinking about palatability, not pounds, as I reach for my bottle of hot sauce.

Source
The Effects of Capsaicin and Capsiate on Energy Balance: Critical Review and Meta-analyses of Studies in Humans [Chemical Senses]

For National Children’s Dental Health Month, the American Dental Association is marking the 10th anniversary of its Give Kids A Smile program, which offers free dental care and education for children in need.

Approximately 80 percent of tooth decay in the U.S. is suffered by 25 percent of the country's children, according to the National Institutes of Health, and according to our recent survey, the biggest reason for delaying dental care is cost.

The survey, conducted by the Consumer Reports National Research Center, asked readers to describe the dental health and cosmetic treatments they received in the last five years. CR subscribers tend to have better insurance coverage than Americans on average, but cost was still cited as a barrier by 43 percent of readers who delayed.

Nancy Metcalf, senior program editor at Consumer Reports, said that because cost is an issue, consumers need to be clear about the line between dental care that is necessary and the procedures they can live without.

Many dentists are trained to push for procedures, both cosmetic and non cosmetic, that will boost their bottom line. We were struck by the finding that nearly a half of those who had had a cosmetic procedure had been prompted to do so by their dentist.

A couple ways to keep dental costs down: Shop around and bargain by first looking up typical insurance paid rates in your area at FairHealthConsumer.org and HealthCareBlueBook.com, then ask providers to accept that amount, or less, as a cash payment. Also consider free and low-cost clinics and health centers. Some community health centers offer dental care with fees based on the ability to pay. Call your local health department to find one nearby.

For more tips see Tips for keeping dental care costs down. The full report Dental do's and don'ts: How to keep your teeth healthy without going broke (available to subscribers), appeared in the February issue of Consumer Reports.

Give Kids A Smile [ADA]

February is National Children’s Dental Health Month, ADA’s National ‘Give Kids A Smile®’ Kicks Off 10th Anniversary Celebration [ADA]

Pfizer has recalled 14 lots of its birth control pills Lo/Ovral-28, and 14 lots of the generic version Norgestrel and Ethinyl Estradiol, because of a packaging error that could cause the daily regimen for these oral contraceptives to be incorrect, leaving women at risk for unintended pregnancy.

An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.

These birth control pills are distributed to clinics, retail pharmacies and warehouses nationwide, and are manufactured and packaged by Pfizer, commercialized by Akrimax Rx Products, and labeled under the Akrimax Pharmaceuticals brand.

Consumers taking the recalled birth control pills should begin using a non-hormonal form of contraception immediately, and notify their physician and return the product to the pharmacy. For a full list of the lot numbers affected by this recall click here.

These products are packaged in blister packs of 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing is important in avoiding the associated risks of an unplanned pregnancy. Adverse events that may be related to the use of these pills should be reported to Akrimax Medical Information at 877-509-3935, or to the FDA's Med Watch Program.

Pfizer Announces Voluntary Nationwide Recall of Lo/Ovral®-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets [FDA]

You now have access to more information about hospital safety, thanks to a step taken by the U.S. Department of Health and Human Services. The agency released bloodstream-infection rates in intensive care units for 1,146 hospitals in Washington D.C. and all states except Wyoming. Nearly a third of the hospitals reported no infections during the reporting period. However, the release covers only the three-month period from January to March, 2011. More data, including from Wyoming, will be added later in the year.

The new data focuses on infections caused by central lines, catheters used to provide nutrition, fluid, and medication but that can also spread deadly infections throughout the body if they’re not scrupulously kept clean. An estimated 27,000 to 65,000 patients develop the infections each year, including 12,000 to 28,000 patients ICUs, according to the Centers for Disease Control and Prevention. Up to 25 percent of the infections are fatal.

More comprehensive information has been available to some people for years. For example, many states now regularly release hospital-infection data. And our Hospital Ratings are based on a year’s worth of data, gathered from the state reports as well as from the Leapfrog Group, a nonprofit organization that collects safety and quality data on hospitals. But if your state doesn’t publicly report infection rates, this may be your first chance to get that information for hospitals near you.

Lisa McGiffert, director of Consumers Union’s Safe Patient Project, says:

Today’s action represents a milestone. Finally, Americans in all 50 states will be able to find out how well their hospital prevents these particular infections. Public disclosure drives hospitals to improve care and helps patients choose hospitals with better safety records.

The new reporting requirements apply to hospitals that participate in the Centers for Medicare and Medicaid Services “pay-for-reporting” program. Virtually all U.S. hospitals, excluding certain hospitals in rural areas that are deemed critical access hospitals, participate because they earn a higher Medicare payment for doing so. In the future, Medicare payments to hospitals will be tied to how well they protect patients from these infections and perform on other patient safety standards.

Beginning this month, hospitals have also started reporting surgical-site infection rates to the CDC. That information will be posted on the government’s Hospital Compare website every quarter beginning in 2013.

For information on more than 3,000 hospitals in all states, including infection Ratings for over 1,000 of them, see our hospital Ratings. Or try our new hospital Ratings app, which can be downloaded from the iTunes app store for $2.99. And see our hospital survival guide for advice on staying safe in the hospital.

If you can’t find your local hospitals in our Ratings, check for the newly released data on Hospital Compare. Consumer Union’s Safe Patient Project offers tips to make the most of the Hospital Compare. Or see a list of publicly available state databases.

The drug Erivedge has been approved by the Food and Drug Administration to treat adult patients with an advanced form of the most common type of skin cancer—Basal cell carcinoma.

The drug is intended for patients with locally advanced basal cell cancer who are not candidates for surgery or radiation, and whose cancer has spread to other parts of the body.

Made by Genentech, Erivedge (vismodegib) is the first FDA-approved drug for metastatic basal cell carcinoma.

The drug was reviewed under the FDA's priority review program, which is an expedited six-month review of drugs that may offer major advances in treatment.

Basal cell carcinoma is generally a slow growing and painless form of skin cancer that starts in the top layer of the skin. The cancer develops on areas of the skin that are regularly exposed to sunlight or other ultraviolet radiation.

The Erivedge drug is a pill taken once a day and works by inhibiting the Hedgehog pathway, which is active in most basal cell cancers and only a few normal tissues, such as hair follicles.

The most common side effects observed in patients treated with Erivedge included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste.

In a press release, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research stated the following:

Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases. This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.

The safety and effectiveness of Erivedge was evaluated in a clinical study with 96 patients with locally advanced or metastatic basal cell carcinoma. Of the patients with metastatic disease receiving Erivedge, 30 percent experienced a partial response and 43 percent of patients with locally advanced disease experienced a complete or partial response.

Erivedge is being approved with a boxed warning alerting stating the potential risk of death or severe birth effects to a fetus.

FDA approves new treatment for most common type of skin cancer [FDA]

Under a new settlement agreement in California, the maker of Brazilian Blowout products is required to warn consumers and hair stylists that two of its popular hair-straightening products emit formaldehyde gas.

The settlement requires GIB, which does business as Brazilian Blowout, to stop advertisements that describe two of its products as formaldehyde-free and safe. Brazilian Blowout must also make significant changes to its website and pay $600,000 in fees, penalties and costs. The settlement also requires that Brazilian Blowout disclose refund policies to consumers before the products are purchased.

In its announcement of the settlement, the California Department of Justice said it was the first government enforceable action in the U.S. to address exposure to formaldehyde gas associated with Brazilian Blowout products, and also the first law enforcement action under California's Safe Cosmetics Act, which went into effect in 2005.

Formaldehyde is a known carcinogen. The Food and Drug Administration received a number of inquiries from consumers and salon professionals concerning the safety of Brazilian Blowout and similar "professional use only” hair smoothing products. In August 2011, the FDA issued a warning letter citing Brazilian Blowout for safety and labeling violations. The action followed a hazard alert the Occupational Safety and Health Administration issued in April 2011 to hair salon owners and workers about potential formaldehyde exposure from working with these products.

In 2010, Brazilian Blowout sued the Oregon Department of Consumer and Business Services after that agency sampled more than 100 “formaldehyde-free” products from 50 salons and found “significant levels” of formaldehyde.

Attorney General Kamala D. Harris Announces Settlement Requiring Honest Advertising over Brazilian Blowout Products [California Department of Justice]
Oregon OSHA reiterates caution to salons using hair-smoothing products [OSHA]
Brazilian Blowout Sues Oregon OSHA over False and Misleading Test Results [Brazilian Blowout]
FDA, OSHA Act on Brazilian Blowout [FDA]

Our updated hospital Ratings show that doctors, nurses, and other clinicians often do a good job of communicating in general with patients, but struggle when it comes to information about drugs and discharge planning. Other research suggests those problems plague patients when seeing health-care providers for routine care, too. Partly in response to problems like those, the Institute of Medicine has convened a panel of experts, including Jim Guest, CEO of Consumer Reports, to come up with ways to improve doctor-patient communication. Here are some of their suggestions.

The panel, brought together by the IOM’s Roundtable on Value and Science-Driven Health Care, identified seven principles of good communication between health-care providers and patients:
1. Mutual respect
2. Harmonized goals
3. A supportive environment
4. Appropriate decision partners
4. The right information
6. Transparency and full disclosure
7. Continuous learning

Take the first principle, mutual respect. The key word is mutual. We know that most patients respect the knowledge and skills of their health-care providers. But respect must go both ways. In the office, that means making sure that your doctor or nurse engages you in making decisions, and understands the insights and preferences that help you make decisions. If you feel that your provider isn’t doing that, have a heart-to-heart with him or her. Or look for a health-care provider who does.

The second principle, harmonized goals, builds on mutual respect. It means that you and your provider have discussed the care options available and the associated risks, benefits, and costs, and that you have arrived at a plan that really reflects your preferences and priorities.

Of course, understanding your best medical options depends on getting complete and accurate information from your health-care provider, being referred when necessary to the right specialist, and seamless communication all-around. That’s where some of the other principles come in. The more that people and their health-care providers work together on these principles, the better care everyone will get.

For more details, see our advice on establishing a good doctor-patient relationship as well as the IOM report Patient-Clinician Commuication: Basic Principles and Expectations. It’s a thought-provoking read.

Nearly 7,000 consumers joined Consumers Union, the policy and advocacy arm of Consumer Reports, in a recent petition supporting regulatory efforts to set national, industry-wide targets to reduce sodium in processed and restaurant foods.

In comments filed with the Food and Drug Administration, Consumers Union highlighted the health risks linked to high sodium, and urged the FDA to work towards limiting intake to 2,300 mg per day, while also encouraging children and those at risk for hypertension to consume no more than 1500 mg per day.

Consumers Union also commended the FDA’s joint initiative with the Food Safety and Inspection Service to reduce sodium consumption in the United States. In a statement Ioana Rusu, regulatory counsel for Consumers Union stated:

Many American consumers are seeking a sensible solution to the growing levels of sodium in processed and restaurant foods. Unfortunately, the answer is not simply to put down the saltshaker, since an overwhelming majority of sodium intake comes from processed, pre-packaged foods.

Excessive consumption of sodium has been linked to increased health risks. The Institute of Medicine estimates that as many as 32 percent of adults in the U.S. have hypertension, and roughly another third have pre-hypertension.

Research has also shown that an excess intake of sodium plays a major role in the development of hypertension-related diseases, such as stroke, coronary heart disease, heart failure, and kidney disease.

It’s not as simple as picking healthier options over junk food, however. In order to compensate for taste, sometimes lower-fat products can be higher in sodium than full-fat counterparts, making healthy choices even more difficult.

For example, Consumer Reports found that a serving of Ruffles Original Potato Chips had 10 grams of fat and 160 mg of sodium, while the baked version, with 7 fewer grams of fat, had 40 mg more sodium.

“Even consumers committed to a low-fat, healthier diet could inadvertently be consuming an excessive amount of salt," Rusu said. "The health risks are too serious to continue the status quo of ever-increasing sodium.”

Calls for Lower Sodium Food Grow, Consumers Union Urges FDA to Limit Sodium Levels in Food [Consumers Union]

Shipments of orange juice from Canada have been stopped at the border after testing by the Food and Drug Administration found low levels of the fungicide carbendazim, which is banned in the U.S. and was previously found in orange juice product shipments from Brazil.

Fungicides are chemical compounds or biological organisms used to kill or inhibit fungi or fungal spores that can damage agriculture.

After fungicide was discovered in the orange juice products from Brazil, the FDA blocked all imports, so that it could test for carbendazim, which studies have linked to a higher risk of liver tumors in animals. The FDA stated previously that for its current testing, if levels of carbendazim are greater than 10 parts per billion, the orange juice product would be destroyed or returned to its country of origin.

On Friday, the FDA said that six shipments from Canada had tested positive for the fungicide. And to date five shipments from Brazil have tested positive.

Thus far, the FDA has collected samples from 80 shipments of orange juice or orange juice concentrate. Of these, 29 shipments tested negative for carbendazim Of the 29 samples.

To date, the samples that have tested positive for carbendazim had levels between 10 and 52 parts per billion. The Environmental Protection Agency has said that levels under 80 parts per billion are not a safety risk. FDA testing of samples from domestic manufacturers is ongoing.

The majority of orange juice for sale in the U.S. is from oranges grown domestically, and about 25 percent is imported, according to figures from the U.S. Department of Agriculture.

It was teh Coca Cola Company, owner of the Minute Maid brand, that originally alerted the FDA that their orange juice and that of their competitors carried residues of the chemical. Coca Cola was legally required to come forward, under the 2008 Amendments to the Food Drug and Cosmetic Act creating a Reportable Food Registry.

If you're concerned about the orange juice that may be currently sitting in your fridge you can look at the label to find its country of origin, and don’t use it if you don’t want to. You can also purchase organic juice.

PREVIOUSLY:
More orange juice imports deemed safe by FDA fungicide tests
U.S. stops orange juice imports due to fungicide

Orange Juice Products and Carbendazim: Addendum to FDA Letter to the Juice Products Association [FDA]
FDA blocks orange juice shipments from Canada [CNN Money]

Many hospitals have succeeded in reducing the number of babies who are delivered early without a medical reason, according to a report from the Leapfrog Group, a nonprofit watchdog organization that collects quality and safety data from hospitals on behalf of employers. In 2010 only 30 percent of hospitals that report data to Leapfrog maintained an early elective delivery rate of 5 percent or less, which experts feel is a reasonable target for hospitals. That figure improved to 39 percent of reporting hospitals in 2011.

The report notes that there is still a lot of room for improvement. Further reducing the number of elective early births could potentially save the healthcare system nearly a billion dollars, and more importantly, prevent unnecessary harm to newborns.

Unborn babies need at least 39 weeks in the womb to fully develop. Early birth can contribute to breathing problems, temperature instability, jaundice, infection, longer-hospital stays, and a higher risk of death. There is occasionally a clear medical reason to schedule a delivery before 39 weeks—if the pregnant mother has high blood pressure or if there are broken membranes before labor begins, for example—but it is relatively rare.

“Of the hospitals that reported an elective delivery rate in 2010 and 2011, 65 percent improved their performance,” said Leah Binder, Leapfrog's chief executive officer, in a statement. “But there is still work to be done. We are seeing far too many newborns delivered early and without a medical reason.”

At some hospitals, scheduling early elective births is anything but rare. The Leapfrog Group's report notes wide variation among the 757 hospitals that report data. Some of those hospitals reported that over 40 percent of their deliveries were done early without a medical indication. And there is no information on the hospitals that don't voluntarily report their data to Leapfrog. “Next we need all hospitals to make the data available to the public,” said Maureen Corry, executive director of the maternity care advocacy group Childbirth Connection, in a statement.

Experts note that there are financial incentives for hospitals and doctors to intervene in childbirths, rather than let the pregnancy proceed on its own course. Some obstetricians may simply prefer to control the scheduling, so labor doesn't occur when they are unable to deliver the child. That’s why choosing a provider is so important, Corry says. Family physicians generally have lower rates of scheduling early deliveries than obstetricians, she says. And midwives generally have the lowest rates. But there are always exceptions, so talk to your provider.

Some women may schedule their births for their own convenience without realizing it increases risks for their child. That's why, Corry says, “it's critical for women to be informed, know their rights, and protect themselves and their babies.” To look for your hospital's rate, see the Leapfrog Group's report.

For more on maternity, see: “Back to basics for safer childbirth,” and “10 over-the-counter drugs to avoid during pregnancy.”

As part of a settlement agreement with the Federal Trade Commission, six online marketers will permanently halt their allegedly deceptive practice of using fake news websites to sell acai berry supplements and other weight-loss products.

The proposed settlements requires the defendants make clear when commercial messages are advertisements as opposed to journalism, and bars them from further deceptive claims about health-related products, such as the acai berry weight-loss supplements and colon cleansers that they marketed.

Among other stipulations of the settlement, the six online marketers are also barred from making deceptive claims about other products, such as the work-at-home schemes or penny auctions promoted by many of them.

The settlements also requires the defendants pay about $500,000 collectively, because their advertisements violated federal law.

We've said before that the claims of acai berry juice might be just hype, and warned that although the berries may be high in antioxidants, there is little evidence that they have special weight-loss or other such powers that you can often touted in ads on the Internet.

PREVIOUSLY:
Marketers of acai products fined $1.5 million for false claims and unfair billing
FTC halts online marketer of acai products for false claims

FTC Permanently Stops Six Operators from Using Fake News Sites that Allegedly Deceived Consumers about Acai Berry Weight-Loss Products [FTC]

Infections in pediatric intensive care units put children's lives at risk and occur all too often, according to a new investigation from the Consumer Reports Health Ratings Center. We found that pediatric ICUs often have higher infection rates than adult ICUs, and that some hospitals do much better than others at preventing infections.

Our investigation focused on a particularly dangerous type of infection—central-line bloodstream infections. We rated 92 pediatric ICUs in 31 states plus Washington, D.C., which publicly reported enough data for us to make statistically valid assessments of their rate of bloodstream infections. Those infections are fatal in as many as one in four cases.

We found that 26 of the 92 pediatric ICUs got low scores for infections, while only five pediatric ICUs earned our highest Rating, reporting zero infections.

Two pediatric ICUs—the University of Virginia Medical Center in Charlottesville and the Loyola University Medical Center in Maywood, Ill.—received our lowest Rating, which means they reported infection rates more than twice as high as the national average. Another 24 hospitals got our second-lowest Rating, with infection rates that were higher than the national average.

“Those hospitals have work to do, but at least they have taken the first step by making their results public,” said John Santa, M.D., director of the Consumer Reports Health Ratings Center. “Taking accountability for infections is reassuring. We’re even more concerned about pediatric ICUs that choose to conceal their infection rates.”

The five hospitals with zero infections are Children's Hospitals and Clinics of Minnesota in St. Paul; Medical University of South Carolina in Charleston; Robert Wood Johnson University Hospital in New Brunswick, N.J.; Tulane Medical Center in New Orleans; and University Medical Center in Las Vegas.

For more on why infection rates are higher in pediatric ICUs, what you can do to keep your child safe, and to view our infection Ratings for all 92 pediatric ICUs, see the full report.

Many newer nutritional supplements are being marketed without the safety assessments required by a federal law, according to an article published today in the New England Journal of Medicine by Pieter A. Cohen, M.D., of Harvard Medical School and elsewhere.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 requires that makers and distributors of supplements introduced after DSHEA became law must notify the Food and Drug Administration and demonstrate that the new ingredients are “reasonably expected to be safe.” But the FDA has not been enforcing the law, according to the article. An authoritative list of “new" supplement ingredients doesn’t even exist.

“It is not known how many of the estimated 51,000 new supplements now on the market include novel (post-1994) ingredients,” Cohen wrote, “but the FDA has received adequate notification for only 170 new supplement ingredients since 1994 — undoubtedly a small fraction of the ingredients for which safety data should have been submitted.”

The supplement industry and the FDA acknowledge that many new products have been introduced without any assessment of safety, according to the article. To address the problem, the FDA in July 2011 proposed draft guidance for the supplement industry detailing when to notify the agency and what types of safety data should be included. “The FDA has decided to implement the law before a public health crisis forces it to do so,” Cohen wrote.

Bottom line. The FDA guidance may be “an important step in the right direction,” according to the article. But Marvin M. Lipman, M.D., chief medical adviser for Consumer Reports, says that even if the guidance is implemented, “DSHEA is a fundamentally flawed law, which affords much more protection to the supplement industry than to the consumer.”

Source
Assessing Supplement Safety — The FDA’s Controversial Proposal [The New England Journal of Medicine]

One of every five U.S. adults over age 18, and almost half of those over age 65, take a daily low-dose aspirin in the hope of preventing heart attacks and strokes, although many have never experienced either condition. Now, a large international study published in the January 9th Archives of Internal Medicine has concluded that using aspirin before disease has struck (primary prevention) may cause more harm than benefit to your health.

In the trial led by British researchers, over 100,000 people, average age 57, who had no history of heart attack and stroke, took a baby aspirin (81mg) everyday for six years. Participants were from nine groups in Europe, Japan, and the U.S. Researchers found that daily aspirin prevented one expected nonfatal heart attack in the large group, and had no significant effect on cancer mortality (which had been suggested in other studies). Disturbingly, these patients collectively experienced a two and a half times greater risk of internal bleeding. More specifically, for every 162 patients, the aspirin caused two cases of serious internal bleeding.

These are surprising results, given the longstanding belief by the medical community that taking a daily aspirin provided excellent cardiovascular preventative benefit with minimal risk. It is important to note that this study focused only on the benefits of aspirin in healthy adults with no previous cardiac or vascular disease. For patients who have experienced a heart attack or stroke or have cardiovascular risk factors such as high blood pressure, diabetes, or smoking, other studies have shown that the benefits of secondary prevention with aspirin outweigh the risks.

The use and dosage of aspirin in both healthy adults and those with disease or risk factors should be considered on a case-by-case basis after consulting with your doctor and pharmacist. Age, gender, risk factors and possible interactions with other medications or supplements must all be considered in making a well-informed decision regarding aspirin prevention strategies for you.

Although it is readily available, it’s not wise to take daily aspirin on your own without consulting your physician, as the drug can pose significant risks. This groundbreaking study dramatically places the focus back on safety.

For more on who may benefit from strategies to prevent heart attacks and strokes, see: Consider low-dose aspirin.

Source
Effect of Aspirin on Vascular and Nonvascular Outcomes: Meta-analysis of Randomized Controlled Trials [Archives of Internal Medicine]

Anyone who’s ever seen me walking the corridors at work, coffee mug firmly in hand, knows that I am a devotee of the coffee bean. Adam, a colleague and friend, is an equally devout worshiper of the tea leaf. Since we both spend our days inundated with food and nutrition research, our conversations often include a battle of the brews-style smack down of the latest research supporting either of our beloved beverages.

Recently there’s been a rash of research on the benefits of the bean that I have delighted in passing on to Adam. But Adam now has a bit of recent backing for his beverage of choice.

A study released today in the January 23, 2012 Archives of Internal Medicine looked at the effects on blood pressure of drinking 3 cups of black tea per day. Researchers from Australia studied 95 regular tea drinkers, ages 35 to 75 years old, who had daytime systolic blood pressure (SBP) between 115 and 150 mm Hg (in other words, the majority had elevated systolic blood pressure). One group was given 3 cups a day of black tea to drink for six months, while the control group was given a placebo that was colored and flavored to match the tea (and had the same caffeine content). Neither group was allowed to consume any other tea during the study.

At the end of six months, the tea drinkers had significantly lowered their blood pressure. True, it was only by a small amount (2 to 3 mm Hg), but for someone with elevated blood pressure, even a couple of points helps. And when looked at in the larger population, the researchers speculated that those couple of points might translate to a 10 percent reduction in the number of people with hypertension, and a 7 to 10 percent reduction in the risk of developing cardiovascular disease.

When Adam and I discussed this study (over cups of coffee and tea), he said he found the study less of a revelation and more of a justification for what he’s already doing. When I asked him if he was thinking about the potential health benefits of his favorite brew, he said: “Not really,” looking with disdain at my coffee mug. “I’m kind of thinking ‘Nyah! Nyah!”

Source
Effects of Black Tea on Blood Pressure: A Randomized Controlled Trial [Archives of Internal Medicine]