Johnson & Johnson to pay $2 billion for false marketing

Johnson & Johnson will pay $2.2 billion to settle charges that the company marketed drugs for unapproved uses and paid “kickbacks” to doctors and nursing homes.

The penalties announced Monday involve fines and forfeiture to the federal government and several states. The settlement involves the schizophrenia drugs Risperdal and Invega, and the heart failure drug Natrecor, the company and Attorney General Eric Holder said.

Johnson & Johnson and two subsidiaries “lined their pockets at the expense of American taxpayers, patients and the private insurance industry,” Holder said.

The penalty amounts to one of the country’s largest health care-related settlements, the Justice Department said.

It also results in what one plaintiff’s attorney called the largest whistleblower payout in U.S. history. Whistleblowers in three states will collect $167.7 million under the False Claims Act.

In 2011, Johnson & Johnson $1.2 billion in fines for deceptive marketing and making false claims about Risperdal. The Arkansas case involved 239,000 violations of the state’s False Claims Act and 4,600 violations of the Deceptive Trade Practices Act.

On Monday, Johnson & Johnson defended Risperdal “as safe and effective for its approved indications” and said two decades of research shows it is “an important treatment option for people with serious mental illness.”

Risperdal was approved by the Federal Drug Administration to treat schizophrenia but was marketed to doctors and nursing homes as a treatment for elderly patients with dementia.

Johnson & Johnson subsidiary will plead guilty to a misdemeanor misbranding charge stemming from the marketing charges.

The company knew patients on the drug were at increased risk for developing diabetes, but did not publicly acknowledge the risk, according to the settlement. The company also promoted the drug in nursing homes in part by sending paid pharmacists to review patient records.

“Although consultant pharmacists purported to provide ‘independent’ recommendations based on their clinical judgment, J&J viewed the pharmacists as an ‘extension of [J&J’s] sales force,'” the Justice Department said. Holder said kickbacks and other incentives could have put the “health of some patients at risk.”

Johnson & Johnson and another subsidiary also marketed Risperdal and Invega as safe for elderly patients, a claim the FDA considered “misleading.” This was done in part through an “ElderCare sales force,” federal officials said.

The heart failure drug Natrecor was marketed as a treatment for patients with less severe heart failure than mentioned in its FDA approval, according to the DOJ statement.

The settlement includes payments to the federal government and several states by Johnson & Johnson, as well as subsidiaries Janssen Pharmaceuticals and Scios.

Source: http://cnnmon.ie/173Tgb7

Weight loss surgery has ‘few’ short-term complications for teens

New research has found that severely obese teenagers who undergo weight loss surgery may experience very few short-term complications. This is according to a study published in the journal JAMA Pediatrics.

 Obesity is a growing problem worldwide, particularly for adolescents. According to the Centers for Disease Control and Prevention (CDC), the percentage of obese adolescents in the US aged between 12 and 19 has increased from 5% in 1980 to 18% in 2010.

Researchers from the US, led by investigators from Cincinnati Children’s Hospital Medical Center, say as the rate of adolescent obesity is increasing, so is the popularity of weight loss surgery (bariatric surgery) as a treatment option.

Researchers say that weight loss surgery for teenagers poses very few short-term complications.

Previous data has indicated that bariatric surgery can be safely offered to obese teenagers, the researchers say. However, they note there have been few comprehensive or prospective studies analyzing the safety and outcomes of weight loss surgery in adolescents.

Source: http://bit.ly/Ht6SRk

Obesity linked to early onset of puberty in girls

The earlier onset of puberty in some girls is linked to obesity, U.S. researchers say.

In Monday’s issue of the journal Pediatrics, researchers found the onset of puberty in terms of breast development varied by body mass index and race among more than 1,200 girls in the study.

“The obesity epidemic appears to be a prime driver in the decrease in age of onset of breast development in contemporary girls,” Dr. Frank Biro of the adolescent medicine division at Cincinnati Children’s Hospital and his team concluded.

The findings suggest that the ages for both early and late maturation in girls may need to be redefined, the researchers said.

The biological impact of early maturation includes greater risk of breast, ovarian and endometrial cancer as well as obesity and hypertension, the study’s authors said. The picture isn’t clear though, since obese children also often become obese adults.

As part of the study, doctors observed and measured breast development of 1,239 girls in San Francisco, Cincinnati and New York City who were aged six to eight when the study began. The girls were examined at least once a year from 2004 to 2011.

Trend observed in Canada

Breast buds started at 8.8 years of age for African-American girls, 9.3 for Hispanic girls, and 9.7 for white non-Hispanic and Asian girls, the researchers found. The onset of breast development in white girls was four months earlier than a previous U.S. study from 15 years ago.

Overall, the findings likely reflect what is happening in Canada and doctors are observing the same trend at clinics in this country, said Dr. Jean-Pierre Chanoine, a pediatric endocrinologist at British Columbia’s Children’s Hospital.

“It’s really the parents who are anxious,” Chanoine said. “It’s not like it’s huge breast development, they just notice it and then they come to the clinic.”

While the results may seem scary to parents, the age of menarche or first menstrual cycle is quite stable, Chanoine noted. In the study, it went from 12.5 years to 12.3 years, which suggests earlier breast development is not associated with earlier full-blown changes of puberty.

Chanoine said there are many potential implications of early puberty, such as an increased breast cancer risk, changes in bone development, or behaviour such as developing an interest in boys at an earlier age. But these are all still open questions that haven’t been proven, he noted.

While the study participants were diverse in racial/ethnic and socio-economic terms, they were not nationally representative, the study’s authors said.

A journal commentary accompanying the study said the factors involved in earlier puberty are complex.

“This article adds to studies providing the unsettling findings that the age of onset of breast development, in synch with, though not entirely explained by the ‘obesity epidemic,’ has continued to drop,” Marcia Herman-Giddens of the University of North Carolina said in the commentary.

Herman-Giddens said low fibre diets, preschool diets high in meat, dairy products are also associated with earlier development. Again, these haven’t been proven.

Biro’s team is investigating whether endocrine-disrupting chemicals, such as plasticizers, are involved.

The study was funded by the U.S. National Institutes of Health.

Source: http://bit.ly/1helBzL

Kids Who Get More Sleep May Consume Fewer Calories

Getting adequate sleep may not just ward off attention and behavioral problems in kids — a small new study suggests it could also affect the amount they eat.

 Researchers from Temple University found that when kids slept more than their usual amount for a week, they consumed fewer calories, had lower fasting levels of the hunger- and weight-regulating hormone leptin, and even weighed less.

“Given all of its documented benefits, in many ways, you can’t lose in promoting a good night’s sleep,” study researcher Chantelle Hart, an associate professor of public health at the university’s Center for Obesity Research and Education, said in a statement.

The three-week study, published in the journal Pediatrics, involved 37 kids between ages 8 and 11, about a quarter of whom were obese or overweight. For the first week, all the kids were asked to sleep their normal amount each night. For the second week, kids were assigned to either sleep 1.5 hours more than their normal amount, or 1.5 hours fewer than their normal amount. In the third week, the kids who were assigned to sleep less in the second week were asked to sleep more, while kids assigned to sleep more in the second week were asked to sleep less. Their sleep time was measured using wrist actigraphs.

Researchers found there was a difference of two hours and 21 minutes of sleep time between the “sleep less” condition and the “sleep more” condition. During the week the kids slept more, they consumed 134 fewer calories a day, on average, and also weighed half a pound less than the week when they slept less. They also had lower fasting levels of leptin during the week they slept more.

“Most of the difference in kcal intake occurred during the additional three hours that children were awake during the decrease condition with children reporting 103 kcal/day more during this time,” the researchers noted in the study.

According to the National Sleep Foundation, school-aged children (ages 5 to 12) should get between 10 and 11 hours of sleep a night. Younger children need even more shuteye; preschoolers, for instance, should get 11 to 13 hours a night, and toddlers need 12 to 14 hours of sleep per 24-hour period.

Source: http://huff.to/1cGGkGl

Demand for doctors will grow as population in US

Driven by an aging population and increased access to health insurance, the U.S. will need more doctors by 2025, says a new study.

The expected rise in demand varies by state and medical specialty, according to the study’s lead author.

“What’s happening at the state level can be very different than what’s happening at the national level,” Timothy Dall told Reuters. He is a managing director at the research and information service firm IHS in Washington, D.C.

The new study, published in Health Affairs, looks at future demands for primary and specialized health care providers. Those specialists include cardiologists, neurologists and urologists.

The researchers used a computer model to estimate future health care demand by taking into account a growing and aging population and increased access to health insurance due to the Affordable Care Act – commonly known as Obamacare.

The U.S. Census Bureau projects the country’s population will increase by 9.5 percent between 2013 and 2025. The Congressional Budget Office also estimates that an additional 28 million people will have health insurance by 2023.

The researchers found the expected increase in doctor demand was largely attributed to a growing number of diseases among an older population. Obamacare, on the other hand, was linked only to an increase of a few percentage points.

Overall, the researchers found the demand for primary care or family doctors will grow by 14 percent by 2025. That’s less than the expected growth among some medical specialties.

Dall and his colleagues estimate that demand for vascular surgeons – who perform bypass surgeries and insert stents, for instance – will increase by about 31 percent and demand for cardiologists will increase by 20 percent.

But those estimates vary by state.

For example, though the demand for cardiologists is estimated to grow by 51 percent in Nevada, demand in West Virginia is only estimated to grow by 5 percent.

Dall cautioned that the estimates are subject to change based on health care delivery systems and behaviors.

For example, Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said conditions that would drive people to see specialists are largely preventable with adequate primary care. Focusing on prevention and primary care would be expected to shift demand toward family doctors.

“As we start to recognize the foundational nature of true primary care and prevention, we’re going to need more primary care providers to be that foundation,” Blackwelder told Reuters.

Blackwelder, who was not involved with the new study, is also affiliated with East Tennessee State University’s James H. Quillen College of Medicine in Johnson City.

“The bottom line is that care delivery patterns will change,” Dall said.

He told Reuters the new study can’t say whether the U.S. will experience a shortage of doctors by 2025.

Previously, the Association of American Medical Colleges estimated that the U.S. doctor shortage will grow to more than 130,000 by 2025.

“It’s important that we continue to update projections and not wait a decade before we update them because things are continually changing,” Dall said.

Read More: http://bit.ly/175VG8U

Teens who eat lots of chocolate tend to be slimmer

Another study appears to find benefits from eating chocolate: researchers from the University of Granada in Spain analzying data on European teenagers found a strong link between high chocolate consumption and low levels of body fat.

Dr. Magdalena Cuenca-García, of the Department of Medical Physiology in Granada University’s School of Medicine, and colleagues report their findings in a recent online issue of the journal Nutrition.

The researchers are part of the HELENA study group, which is collecting and analyzing data about the diets, fitness and various health measures among European adolescents.

Previous studies have already found that regular chocolate consumption is linked to leanness in adults. There is also evidence that eating chocolate may reduce cardiovascular disease risk.

Eating chocolate ‘may help youngsters stay slim’Chocolate squares

Researchers from Spain have found that teens who eat chocolate have lower levels of total fat and fat around the middle than those who abstain.

The Spanish researchers decided to use the HELENA data to see if the same could be said of teenagers.

They analyzed records on 1,458 adolescents from nine European countries who were aged from 12 to 17 and who had completed computer-based questionnaires asking them to recall what they had eaten in the previous 24 hours on 2 non-consecutive days.

The records also contained information from which they could assess participants’ BMI, waist circumference, body fat measures and activity levels.

The results showed that higher chocolate intake among the teenagers were linked with lower levels of total fat and fat around the middle, regardless of other factors (including exercise).

The researchers in this study did not examine why chocolate appears to help the youngsters stay slim, but some previous studies have suggested it could be something to do with the flavonoids it contains.

Flavonoids are a group of polyphenolic compounds known to have numerous beneficial biochemical and antioxidant effects. For example, they appear to protect against cardiovascular disease through antioxidant, anti-clotting and anti-inflammatory properties.

“It’s also possible that flavonoids in chocolate may decrease blood concentrations of bad cholesterol and reduce blood pressure,” says Dr. Susanna C. Larsson, of Sweden’s Karolinska Institute, where she and her team conducted a study of Swedish men that found chocolate consumption may also lower stroke risk.

Many researchers say it is dark chocolate that is good for the heart, but Dr. Larsson says, surprisingly, that 90% of the chocolate eaten in Sweden – as they also found in their study – is milk chocolate.

Source: http://bit.ly/18UTv2v

Malaria cases hit 40-year high in US

Nearly 2,000 people were diagnosed with malaria in the U.S. in 2011, a 40-year high for the infection, health officials reported Thursday.

 Most were among U.S. residents or citizens and virtually all cases were brought back from other countries, the U.S. Centers for Disease Control and Prevention reported. People need to watch out for the mosquito-borne infection, the CDC cautioned.

“In 2011, 1,925 malaria cases were reported in the United States,” CDC said in a statement.

“This number is the highest since 1971, more than 40 years ago, and represents a 14 percent increase since 2010. Five people in the U.S. died from malaria or associated complications.”

In 1970, 4,247 malaria cases were reported in the U.S., almost all of them among U.S. military personnel. That was the height of the Vietnam War. In 1971, 3,180 cases were reported.

In 2011, just 91 cases were in military personnel. Soldiers, sailors, marines and airmen deployed in malaria-ridden zones are now given drugs to prevent infection. New York City had the most cases in 2011, with 238 cases, the CDC team said.

Almost all the cases were imported, 69 percent of them from African countries where malaria is common. One of the infected people got the parasite through a blood transfusion, two babies were born infected and one case cannot be explained.

The malaria parasite is spread by mosquitoes and can live for years in the human body. When a mosquito bites an infected person it can pick up parasites and then transmit them to someone else – meaning malaria can be introduced by an infected traveler. It also means blood transfusions can transmit infections – that’s happened in 97 cases since 1963, CDC says.

“Malaria isn’t something many doctors see frequently in the United States thanks to successful malaria elimination efforts in the 1940s,” CDC director Dr. Tom Frieden said in a statement.

“The increase in malaria cases reminds us that Americans remain vulnerable and must be vigilant against diseases like malaria because our world is so interconnected by travel.”

Malaria killed 660,000 people globally in 2010. Symptoms include fever, headache, back pain, chills, sweating, muscle pain, nausea, vomiting, diarrhea and cough.

“Malaria is preventable. In most cases, these illnesses and deaths could have been avoided by taking recommended precautions,” said Dr. Laurence Slutsker, director of CDC’s division of parasitic diseases and malaria.

CDC lists drugs approved to treat and prevent malaria. They include Malarone, chloroquine and the antibiotic doxycycline. There’s no vaccine yet.

Another drug, mefloquine hydrochloride, sold under brand names including Lariam, Mephaquin or Mefliam, can cause severe side effects including hallucinations and is considered a drug of last resort. The Food and Drug Administration strengthened warnings about the pill in July.

Source: http://nbcnews.to/1801hIQ

Strep throat home test ‘could save thousands of doctor’s visits’

Researchers have created a home test for strep throat that they say is almost as accurate as laboratory tests and could eliminate the need for doctor’s visits for sore throat. This is according to a study published in the journal Annals of Internal Medicine.

 Strep throat is a type of sore throat caused by a bacteria called Streptococcus pyogenes, also known as group A streptococcus (GAS).

This form of bacteria is highly contagious and can be spread through airborne particles when an infected person coughs or sneezes, or through touching infected surfaces.

When a patient visits their physician complaining of a sore throat, they may have a laboratory test carried out to determine whether their sore throat is bacterial or viral. However, a laboratory test may be unnecessary for patients who are deemed as low-risk for strep throat.

The research team from Boston Children’s Hospital and the University of California, San Diego, says the newly created strep home test involves a scoring system that determines whether a patient’s sore throat is viral or bacterial, potentially eliminating the need for doctor’s visits.

The home scoring is based on a patient’s personal health information that is provided by them directly and an assessment of any recent strep encounters within the general population.

The patient’s scores are then compared to traditional “Centor” scores used in laboratory tests to determine whether a patient has strep throat. If a patient’s score shows the likelihood of strep throat to be less than 10%, they are deemed as low-risk.

Doctor’s visits ‘could be reduced by 230,000 a year’

To determine whether the home strep test is accurate, the researchers analyzed 71,776 patients aged 15 years or older who had pharyngitis (sore throat) between 2006 and 2008.

Of these patients, 48,089 were tested for strep throat using laboratory tests at a health clinic, while 23,687 used the home strep test.

Of the patients who were tested during doctor’s visits, 11,614 (24%) tested positive for group A streptococcus pharyngitis, while 5,728 (24%) tested positive using the home test.

From these results, the researchers estimate that if patients aged 15 years or older with sore throats who scored less than 10% on the home strep test avoided visiting the doctors for the “Centor” test, this could reduce doctor’s visits in the US by 230,000 each year and reduce the number of patients prescribed “unnecessary” antibiotics for strep throat by 8,500 each year.

Commenting on their findings, the researchers say:

“The model, based on history and recent, local disease patterns without physical examination information, could help clinicians and patients estimate the likelihood of disease before a clinical encounter and help steer these patients to timely, appropriate care when needed.

In some instances, patients unlikely to have GAS pharyngitis might avoid, or at least delay, an emergency or outpatient visit.”

Researchers have ‘overestimated specificity’

However, in an editorial linked to the study, Robert M. Centor, from the University of Alabama, says that the researchers have “overestimated the specificity” of the home strep test.

“Derivation models almost always give better results than validation data sets,” he says. “We should use the specificity that they found in their validation data as a more accurate estimate of how this model would work in the future.”

He adds that although the goals of the researchers are “admirable,” he doubts that the home test approach is practical or cost-saving for patients, and he details other areas in which savings could be made, such as using recommended generic antibiotic treatment for pharyngitis rather than more expensive options.

Source: http://inagist.com/all/397635658690224128/

Mediterranean diet linked to longer lifespan

Britons who are looking for healthy diet plans following the festive period may want to look to the Mediterranean, after research found that the traditional diet promotes longevity.

 The much-celebrated dietary regime focuses on vegetables and fish, with fewer animal-based products such as meat and milk.

Scientists at Sweden’s Sahlgrenska Academy analysed data on thousands of 70-year-olds, some of whom followed a Mediterranean diet while others ate a regular diet with a greater emphasis on meat products.

They found that people who ate a Mediterranean diet were 20 per cent more likely to live longer than those who did not.

Researcher Gianluca Tognon revealed: “This means in practice that older people who eat a Mediterranean diet live an estimated 2.3 years longer than those who don’t.”

He concluded that a Mediterranean diet “is linked to better health, not only for the elderly but also for youngsters”.

People who are interested in following a traditional Mediterranean diet in the new year should increase their intake of fruit and vegetables, avoid processed foods and eat plenty of healthy fats from fish, nuts and olive oil.

Source: http://bit.ly/1aoDh20

Preterm birth rate drops to 11.5%

The number of premature babies born in the US dropped to 11.5% in 2012 – a 15-year low, according to the March of Dimes Premature Birth Report Card. However, the change was not enough to alter the overall grade given to the nation – that remains a “C.”

There is no room for complacency, as March of Dimes points out 1 in 9 babies – 450,000 a year – are born too soon.

March of Dimes defines preterm birth as before 37 weeks of pregnancy, and babies born too soon have higher rates of death and disability than full-term babies.

Early babies may face serious and sometimes lifelong health issues – including breathing problems, developmental delay, vision loss and cerebral palsy.

Even babies born at 37-38 weeks have a higher risk of health problems than those born at 39 weeks. Physicians from the University of Buffalo highlighted this in a recent study reported inMedical News Today.

As well as the health implications, there are the financial costs. As March of Dimes President Dr. Jennifer L. Howse explains:

“A premature birth costs businesses about 12 times as much as an uncomplicated healthy birth. As a result, premature birth is a major driver ofhealth insurance costs not only for employers.”

The National Center for Health Statistics says that the national preterm birth rate peaked in 2006 at 12.8%. Since then, March of Dimes estimates that 176,000 fewer babies were born preterm – with a potential saving of $9 billion in health and societal costs.

Dr. Howse continues:

“Although we have made great progress in reducing our nation’s preterm birth rate from historic highs, the US still has the highest rate of preterm birth of any industrialized country. We must continue to invest in preterm birth prevention because every baby deserves a healthy start in life.”

Since 2003, March of Dimes has been campaigning to reduce premature births nationally and has set a goal of 9.6%. Across the US, only six states – Alaska, California, Maine, New Hampshire, Oregon and Vermont – met this target and achieved an “A” grade.

Top marks for state with highest birth rates

March of Dimes singles out California’s achievement as being particularly noteworthy, pointing out that not only does it have the highest birth rate of all the states – with 500,000 births each year – it also has a racially diverse population living in urban, suburban and rural communities.

According to the Report Card, the grade ranges were established in 2011 using a specific formula. Scores were then rounded to one decimal point, resulting in the following scoring criteria:

Grade     Preterm birth rate

A             Less than or equal to 9.6%

B             Higher than 9.6% but less than 11.3%

C             Greater than or equal to 11.3% but less than 12.9%

D             Greater than or equal to 12.9% but less than 14.6%

E              Greater than or equal to 14.6%

March of Dimes 2013 Report Card shows that 31 states saw improvements in their preterm birth rates, with the grades breaking down as follows:

  • Six states achieved grade A
  • 19 states achieved grade B
  • 17 states and the District of Columbia received grade C
  • Five states achieved grade D
  • Three states – Louisiana, Mississippi and Alabama – and Puerto Rico received grade F.

Non-Hispanic black infants remain at greatest risk of preterm birth at 16.8%, although this number has fallen from 18.5% in 2006. And while the gap between blacks and whites is narrowing, preterm birth rates among non-Hispanic black  babies is still more than 1.5 times higher than non-Hispanic whites.

March of Dimes also looked at some contributing factors to early birth and noted reductions in the number of women of childbearing age who smoke in 35 states. They also recorded reductions in the percentage of uninsured women of childbearing age in 37 states, as well as the District of Columbia and Puerto Rico.

Source: http://www.medicalnewstoday.com/articles/268339.php