20 April 2012

Novartis Updates Drug Labels

Story first appeared on Reuters.
Novartis International AG / Novartis updates US label on GilenyaR following discussions with the FDA . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

  • Updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the United States.
  • Prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment.
  • Update to label marks the conclusion of discussions initiated in December 2011.

Basel, April 20, 2012 - Novartis announced today agreement with the US Food and Drug Administration (FDA) on label changes for GilenyaR (fingolimod). These changes are an attempt to alleviate any unrest about their drug related to recent reports of death, according to Washington DC Personal Injury Lawyers.

The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing forms of MS in the United States. The update marks the conclusion of discussions initiated in December 2011.

The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observation period in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted.

As of February 2012, approximately 36,000 patients have been treated with Gilenya in clinical trials and in the post-marketing setting.

Gilenya represents an important treatment option for relapsing forms of MS. Choosing appropriate patients for Gilenya therapy and patient safety is essential.


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Care-Related Infections Going Down

Story first appeared in Fox News.

The United States is making progress in reducing the spread of infections to patients while they are in the hospital, the Centers for Disease Control and Prevention said on Thursday.

Twenty-one states reported reductions in so-called "central line" bloodstream infections from 2009-2010, according to the federal health agency, which used data from a state-by-state tracking system. According to Baltimore Medical Malpractice Lawyers, this reduction shows great progress in reducing the amount of medical malpractice claims.

A central line is a tube inserted into a large vein of a patient's neck or chest for treatment, often while the patient is in intensive care. When not put in correctly or kept clean, the lines can become a freeway for germs to enter the body and cause serious bloodstream infections.

Nationwide, there was a 32 percent decline in central line bloodstream infections from 2009-2010, said the deputy chief of the surveillance branch in the CDC's division of health care quality promotion. The decline was even greater at 35 percent among intensive care patients. The redued number of health-care related infections can be attributed to national and state prevention efforts.

There were smaller reductions in infections caused by other surgical procedures. There's a lot of room for progress with surgical site infection prevention.

With a state-by-state reporting system called the National Health Care Safety Network, launched in 2006, hospitals can compare their own infection rates with similar facilities. More than 5,000 acute-care hospitals now report data to the network.


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19 April 2012

Simple Test for Babies to Determine Heart Problems

Story first appeared in the Detroit Free Press.

It's a simple test, but it can make a life or death difference for newborns with a previously undiscovered heart defect. Pulse oximetry in infants -- a variation of the finger-clip test many Americans get to determine whether the heart is pumping blood effectively -- is being added in U.S. hospitals -- including a dozen in Michigan -- as a common newborn screening tool.

There's also a push here and in other states to pass laws, as Indiana and Maryland have, to require the test, according to a support group, PulseOx Advocacy, which tracks the issue on its website.

A lot of newborns can be discharged without knowing they have significant problems with the heart. Each year, between 4 and 10 out of every 1,000 children born in the United States will have a congenital heart defect. Of those, more than 1,500 won't live to have a first birthday, according to the American Heart Association.

Fortunately, detection tools have improved so much that many of the problems are found by fetal ultrasound tests during pregnancy or during exams by pediatricians after birth. For those that are not found prior to birth, pediatric pulse oximeters make the difference.

One baby of 14,017 tested at the University of Michigan between 2006 and 2010 was diagnosed through pulse oximetry testing with a heart problem that otherwise would have gone undetected.

U-M has routinely offered the newborn screening since 2003 because it saw a benefit to the tests and, as a teaching hospital, had pediatric cardiologists readily on staff. Michigan doctors are working with the Michigan Department of Community Health to create a statewide system so that babies born at hospitals without pediatric cardiologists get the right, immediate follow-up if they flunk a pulse oximetry test showing that their hearts don't pump oxygen effectively.

In a smaller community hospital, we need to make sure cardiologists are available to see patients.

Most of the 60 Michigan hospitals that deliver babies have fewer than 1,000 births a year and of those, half have fewer than 500 births -- places unlikely to have pediatric cardiologists on staff.

Michigan applied for a $300,000 federal grant to gather statistics about the screening and follow-up tests and treatment.

The project also will look at whether there are more inaccurate readings -- usually suggesting a problem that isn't there -- if the pulse oximetry test is performed after the first day of life, as is done in England without big problems.

2-minute test
Over the past few months -- and as recently as last week -- metro Detroit hospitals adding the test include Hutzel Hospital, Detroit; St. John Providence, Southfield, and St. Joseph Mercy Oakland, Pontiac, according to doctors and hospital spokespersons.

Others expect to start soon, including the Oakwood Healthcare system in Dearborn, St. Mary of Livonia and Beaumont Health System based in Royal Oak, spokespersons said.

Pulse oximetry is best at finding heart defects that result from poor oxygen circulation in the blood. It's usually performed 24 hours after a baby is born -- while most infants still are in the hospital. If the test picks up something suspicious, it often is repeated once or twice within the next few hours.

It's recommended that babies discharged before 24 hours after birth get the test within a few days at their pediatrician's office.

The tests take about two minutes. Sensors are attached with tape to a baby's hand and foot. St. John Hospital spent $16,900 to buy new motion-resistant machines for its labor and delivery unit.

Proponents hope to get the Michigan Lt. Governor to help push for mandatory testing. His then-15-month-old daughter underwent open-heart surgery last May for a congenital heart defect.

The Lt. Governor who has another child with autism, played a similar role recently in the passage of legislation to require insurance coverage for autism care.

For now, the Michigan Governor's office said it will review any legislative proposals and is working with hospitals to develop a coordinated system.

Push for a testing law

Several local groups, including Hearts of Hope, support a state testing law involving pediatric pulse oximeters.

A  Royal Oak woman's son, now 3 1/2, was born with a hole in his heart and a narrowing of a key valve and artery. The condition left him too weak to breastfeed. After he lost a pound of his birth weight and continued having nursing problems, she brought him to his pediatrician, who recommended he see a pediatric cardiologist.

When the diagnosis came, it was like the air shifted in the room.

He had heart surgery when he was just 9 months old. Today, he's doing fine, loves his gymnastics class and calls his younger brother his best friend. His long chest scar is nearly gone and he has stretched his follow-up appointments with a Beaumont pediatric cardiologist to every two years.


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Possible Correction for Cerebral Palsy Symptoms

Story first appeared in Bloomberg Businessweek.

Nanoparticles laced with a medicine for Tylenol poisoning and sent into the brains of baby rabbits eased symptoms of cerebral palsy, according a study that points to a potential approach for treating humans with the disorder.

Using nanoparticles called dendrimers, researchers were able to penetrate the brain’s natural barriers to deliver a medicine into the animals, quelling the inflammation that can lead to cerebral palsy, according to research published today in the journal Science Translational Medicine.

Cerebral palsy, a lifelong neurological disorder that affects movement, is caused by an abnormality to an infant’s brain that occurs in the womb or early in life. Often cerebral palsy is caused by medical negligence in the birthing process. In the study, newborn rabbits with the condition were injected with the therapy, and within five days showed “significant” improvement in their ability to move, as well as reduced inflammation in the brain.

Reaching the inflamed cells in the brain has been a long-standing major challenge. Dendrimers not only go into brain, they go specifically into the cells called activated mycrogia that are the source of the problem. So then we attached a drug to it, and shut them down in a targeted manner.

The scientists attached the anti-inflammatory drug called N-acetylcysteine to the nanoparticles, which are the tiniest engineered materials. The medicine, long used as an antidote for Tylenol poisoning, helped suppress immune cells called mycrogia and astrocytes. The cells, which respond to the site of injury, can cause damage to normal brain tissue as they spur an overheated inflammatory response.

Activated Mycrogia


The activated mycrogia cells are also linked to other neurological diseases such as Alzheimer’s, stroke, Parkinson’s, and multiple sclerosis.

There is no cure for cerebral palsy, a disorder that is diagnosed in as many as four infants of 1,000 worldwide, according to the U.S. Centers for Disease Control and Prevention. People with the cerebral palsy often need special equipment to walk, and can suffer from stiff muscles, uncontrollable movements and poor balance and coordination.

Researchers focused on rabbits because like humans, they start developing motor skills before birth and complete it after, while most other mammals finish before being born.

Since humans aren’t typically diagnosed with cerebral palsy until they are at least 18 months old, researchers will test to see if the therapy has the same effect on rabbits when injected later in life. Another hurdle is that dendrimers haven’t been approved for use in humans.

They do not know if it will work in humans, however, they have made a big paradigm shift in the way people think about this disease, because people think this cannot be reversed.


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18 April 2012

Community Health Centers Offer Differing Levels of Care

Story first appeared in USA Today.

At Oakhurst Medical Center in Stone Mountain, GA, just 20% of children have received all their recommended immunizations by age 2.

Adults don't fare much better at this community health center, which provides primary care to 14,000 mostly poor people in a town famous for its granite monolith and "Confederate Mount Rushmore," just east of Atlanta.

Fewer than half of its diabetics and a little more than a third of those with high blood pressure had their conditions under control in 2010 — far below national averages for the U.S. population, according to a Kaiser Health News-USA TODAY analysis of the latest federal data.

But 65 miles east of here in Greensboro in rural central Georgia, it's a different story. At TenderCare Clinic, almost all children get the appropriate immunizations, and eight out 10 diabetics have normal blood sugar levels.

The marked differences between Oakhurst and TenderCare underscore the wide variability in how well community health centers are caring for millions of people nationwide.

There is tremendous performance variation within community health centers and also tremendous variation among any health providers, hospitals, nursing homes, doctors. That's the American health system.

Lower-performing centers typically have a higher proportion of uninsured patients and more staff turnover. Most also lack electronic record systems, which makes it harder to track patients.

Oakhurst has many of those challenges. It is one of eight community health centers nationwide whose patients fell below the U.S. average for all six quality care indicators in 2010 — diabetes and blood pressure control, cervical cancer screening, childhood vaccinations, timely prenatal care and low birth-weight babies.

The difficulties he faces include high rates of obese patients; many African immigrants are unaccustomed to seeking preventive care such as vaccinations; and 40% of patients don't have health insurance.

Another issue: Patients who don't follow recommendations. A middle-aged patient is a prime example. She has been coming to the Oakhurst clinic for three years and despite her doctor's urgings, she refuses to take blood pressure medicine after having a bad experience with one drug. The drug in question caused her hair to shed, so she stopped taking it. She is on Medicaid like almost half the center's patients.

The center is doing a number of things to boost care. Staff members now routinely ask parents about getting their children immunized, no matter why they came in. The same goes for women who are due for a Pap test. And an electronic health records system is being installed, which will help monitor patients.

But it is an uphill battle. Last year, Oakhurst identified more than 300 patients as high-risk because they are obese, diabetic or have high blood pressure and asked them to enroll in a free nutrition class. Only 18 signed up.

In rural Georgia, some of those same issues bedevil TenderCare — no-show rates top 30% overall and 70% for Medicaid clients because of transportation difficulties.

But TenderCare uses case managers and counselors to make reminder calls, do in-house counseling and troubleshoot other issues that might interfere with patients' care — efforts that have helped the center achieve some of the best quality scores in Georgia.

A medical assistant plays a starring role. Using a phone in a corner of the room reserved for minor surgical procedures, she calls parents who are late bringing in kids for immunizations, women behind on getting their annual Pap tests and the diabetics who have neglected their monthly checkups.

In a nearby office, the Health Education Coordinator intercepts patients after they meet with doctors to advise them about nutrition, set exercise goals and put them through diabetes school.

Still, it's not unusual for patients to tell him they cannot keep appointments because they couldn't pay a family member for a ride.

The center also has trouble finding specialists and hospitals willing to provide surgery to its uninsured patients. While many health centers have trouble finding specialists and hospitals to do surgery on patients without insurance, TenderCare is in a more precarious spot because it is outside the areas covered by Grady Memorial, the large public hospital in Atlanta, and Medical College of Georgia in Athens.

In the past year, an uninsured man waited more than eight months to find a neurosurgeon to operate on a brain tumor. An uninsured woman died of cervical cancer after waiting a year to find a surgeon.

The clinic's remote location also has some pluses, though. As one of the few health providers in town, TenderCare has been able to attract patients with Medicare and private insurance that pay higher rates than Medicaid. That helped the center privately finance a new $3 million building in 2009.

TenderCare is also more advanced than most rural health centers with its computerized pharmacy dispensing system to reduce errors.

Some patients still struggle. A heavyset woman from nearby Eatonville, Ga., is uninsured. On a recent visit her blood sugar was 456, almost three times normal. Her blood pressure is also high, and her vision has started to blur because of her decade-long struggle with diabetes. She can't seem to avoid the sugars and sweets.  She attributes her bad decisions to her bad health.


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