FDA, DOJ Take Action Against Johnson & Johnson-McNeil

Cristina Arias/Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration and the Department of Justice announced Thursday afternoon that McNeil Consumer Healthcare (a unit of Johnson & Johnson) and two of its executives have been accused of violations of federal law for failing to comply with good manufacturing practices in connection with a series of product recalls and poor inspection reports at its manufacturing facilities.
Without admitting or denying the allegations, McNeil has entered into a consent decree with the government that places three of the company’s plants under supervision of the FDA. The decree also prevents them from reopening their Fort Washington, Pa. plant until it has been found by the FDA to be in compliance with the law.
McNeil can continue operating two of its other plants, one in Puerto Rico and the other in Lancaster, Pa., but the company must submit to independent inspections and adhere to a strict timetable to bring those facilities into compliance.

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New Study Shows Age Affects Us All

Comstock/Getty Images(AMES, Iowa) -- If you thought the aging clock ticked differently for humans than it does for animals, think again! It has been believed for a long time that humans aged slower than most animals due to the long life spans and access to modern medicine. However, a multi-species study in the journal Science compares the human aging patterns with those of chimps, gorillas and other primates.

The study suggests that the pace of human aging may not be so unique after all. The researchers combined data from long-term studies on seven species of wild primates, such as monkeys from Costa Rica, baboons from Kenya and chimpanzees from Tanzania, and compared them with those of humans. The important finding: The aging rates were similar for both primates and humans. They also found males had higher age-specific mortality than females across most of the primate species. However, there was an interesting exception to males dying at a younger age. The males did not die earlier than the females in a species of monkey from Brazil where males do not compete with each other for access to mates. This suggests that in other primates maybe males die faster because of stress and strain of competition. The authors point out that looking at other primates would definitely help us understand the factors that govern the maximum life span.

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Study Finds Three Times-a-week Insulin Improves Glucose Levels

Jeffrey Hamilton/Thinkstock(NEW YORK) -- If Vicki Taniwaki eats three meals in a day, she will have "stuck" herself with insulin at least five times by the time she goes to bed at night.

Taniwaki has been diagnosed with type 1 and type 2 diabetes. She must take two basal injections, or background insulin, and three bolus injections, an insulin to control her glucose levels after meals, every single day of her life.

But, as normal as this routine has become for Taniwaki, who was diagnosed with type 2 diabetes in August 2007, she said there is certainly room for error with all those sticks and pricks.

"Anything you do that much becomes routine, but the opportunity to screw it up also goes up as you become more lax and comfortable with it," said the 50-year-old.

When Taniwaki heard about a study that found the background shot of insulin could be lowered from one or two times a day to three times a week, she said it could be a positive change to her day.

"Anything that would diminish or curtail that maintenance routine would be good," said Taniwaki. "Some people could argue that then you would have to worry about trying to remember when you did that background injection, but if I could do roughly half of what I'm doing now I would be very happy."

While the new type of insulin is not available on the market right now, Taniwaki could be cutting back on stick and pricks in the future.

A new study, published in the Lancet, found that a longer acting form of insulin, known as degludec, is just as effective as the existing long-lasting insulin, glargine.

One injection of glargine lasts 18 to 26 hours, but study participants who used degludec had the same amount of blood sugar control as glargine while only getting injected three times a week instead of daily.

Copyright 2011 ABC News Radio


More than One in 20 Americans over Age 20 Is a Cancer Survivor

Duncan Smith/Thinkstock edit Delete caption(NEW YORK) -- Cancer no longer sounds the death knell it once did.  In fact, more Americans are living with cancer than ever before.

According to a new study by the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC), one in 20 Americans over age 20 is now a cancer survivor.

Using data compiled by other cancer studies, the NCI and CDC found that the estimated number of cancer survivors in the U.S. increased from 10 million in 2001 to almost 12 million in 2007.

The data also revealed that women had a higher rate of survival than men. Almost two-thirds of all cancer survivors as of January 1, 2007 had been living with the disease five years or more.

The most common cancers diagnosed were breast, prostate and colorectal. 

The majority of survivors were seniors 65 and older, while fewer than one percent were 19 or younger.  Many of those had leukemia.

Researchers cite several reasons for the increased cancer survival rate including advancements in screening and early detection, more effective treatment and clinical follow-up, and an aging U.S. population.

If these trends continue, the number of cancer survivors is expected to climb even higher.

Copyright 2011 ABC News Radio


Two-Thirds of Americans Live With Voice Disorders

ABC News(NEW YORK) -- Sarah Palin and Hillary Clinton may be miles apart in their opinions about how to deal with the Middle East crisis, but they do have one thing in common: They both live with something called cheerleader's voice syndrome.

When Clinton fires off a verbal warning to the likes of Muammar Gaddafi, she tries to project authority and confidence, but instead her vocal cords rub together too forcefully and create a sound that's abnormally tense and grating. And when Palin shouts "Drill baby drill!" it comes across as shrill, baby, shrill.

Few would argue with these bipartisan auditory observations.

"Cheerleader's voice syndrome is just one of the many voice problems Americans suffer from," said Russian-born opera singer turned voice coach Elena Zoubareva, who, with the help of a Harvard ears, nose and throat specialist and speech language pathologist, has developed a new voice training program called FitVoice.

Zoubareva said that about two-thirds of Americans -- more than 28 million people -- experience voice problems daily. The damaged voice boxes of schoolteachers alone cost American taxpayers $2.5 billion in missed workdays each year.

To Zoubareva's ear, women are usually worse offenders than men. "Many women speak like this," she said, dropping her voice several throaty octaves to verbally illustrate her point. "They sound from the chest and there is a tendency to speak lower than their optimum pitch level."

The reason for this, Zoubareva speculated, is that consciously or subconsciously, women believe lower tones are sexier and will get them noticed more in business and by the opposite sex. Like the squeaky cheerleaders, those with this so-called Bogart-Bacall syndrome are also trying to exude more confidence, strength and authority. Think of Lauren Bacall, the syndrome's namesake, as the worst-case scenario.

"In the beginning, Bacall had a much higher, normal sounding voice," Zoubareva said. "But somewhere along the line she was probably advised by a director or producer to try to sound sexier, and so she learned to lower her voice quite a bit."

For their troubles, both groups of women are often rewarded with nodules, which form like calluses on the vocal cords. These can eventually harden and scar to produce a permanently hoarse, strained speaking voice.

Lest men feel smug about their sonorous superiority, they should be reminded of their own special brand of phonotraumatic habits. Zoubareva identified a problem she dubbed sports fans voice, acquired after years of listening to the Red Sox fans in her adopted hometown of Boston scream themselves into a voiceless frenzy by the end of every game. All that unfettered shouting and cheering can lead to the growth of polyps on the vocal folds, which can so damage the voice that they could require surgical repair.

Copyright 2011 ABC News Radio


Toddler Who Suffers from FPIES Can Only Eat Five Foods

BananaStock/Thinkstock(HOWELL, N.J.) -- Fallon Schultz, a 28-year-old clinical social worker from Howell, N.J., has known since her son Landon was two weeks old that something was wrong.

He had horrible eczema and would scream day and night, projectile vomiting after feeding as if he were allergic to her own breast milk.  At her pediatrician's advice, Schultz switched to soy and then to a nutrition formula, but it got much worse.  Landon had diarrhea filled with blood and mucus, 10 times a day, and soon he began bleeding from the worsening eczema under the hair on his head.

After consulting with various doctors, Schultz finally got a diagnosis in 19 months later.  Landon was found to be suffering from food protein induced entercolitis syndrome, or FPIES, a condition so severe that Landon can only eat five foods: ripe strawberries, blueberries, avocados, grapes, raisins and elemental formula.

Landon was diagnosed by doctors at the Children's Hospital of Philadelphia.  And now the hospital's foundation has agreed to join Schultz in setting up her new nonprofit, the FPIES United Family Fund to support education and advocacy, and to find a cure for the syndrome.  She is hoping to raise an initial $300,000 from corporate sponsors to raise awareness.

"Local doctors don't know about the disease and because that they don't pick it up. [Landon] has permanent damage and is not going to get better," said Schultz.  "If you don't have something that is cookie-cutter, they think you are crazy.  I am trying to turn something that has been a nightmare to help someone else's child.  It's been a long two years."

Doctors don't even have an ICD-9 code to diagnose FPIES, according to the United Family Fund, which is pushing for that medical diagnostic tool.

"Our lives have been taken over by FPIES, and I am just trying to do everything I can as a mother to help him and other children affected by this cruel disease," she said.  "I want to do something big.  I want these kids to be better.  It's not good enough for my son and/or the kids going through this."

Landon cannot eat 27 fruits, vegetables, milk and soy products, grains and meats.  If he does, he is in excruciating pain.  Then, for days afterwards, his body fights the proteins in the food, damaging his gut and causing such dangerous vomiting and diarrhea that he runs the risk of going into a septic-like shock.

Experts have no idea how many children suffer from FPIES.  Most will outgrow it in four or five years, but Landon's case is so severe, no one can predict his prognosis, according to Schultz.

Copyright 2011 ABC News Radio


FDA to Hold Meeting on Anesthesia's Link to Learning Disabilities in Kids

Pixland/Thinkstock(WASHINGTON) -- Advisers to the U.S. Food and Drug Administration will hold a panel meeting Thursday to explore whether or not anesthesia use in children can cause learning disabilities.

Studies in the past have shown a possible link between anesthesia exposure in young rats and monkeys and the death of their brain cells.  However, that link has not yet been made clear in humans.  But a 2009 study reported in Anesthesiology, found that children who were exposed to anesthesia twice before the age of four were 59 percent more likely to be diagnosed with learning disabilities than those who weren't.

"We need to definitively answer the questions of whether anesthetic use in children poses a risk to their development and, if so, under what circumstances," Bob Rappaport, MD, the head of the FDA's anesthesia and analgesia products and his colleagues wrote in an article published Wednesday in the New England Journal of Medicine.

Copyright 2011 ABC News Radio


FDA Approves First Lupus Drug in 50 Years

Comstock/Thinkstock (WASHINGTON) -- The U.S. Food and Drug Administration on Wednesday approved Benlysta, the first lupus drug in half a century.

The drug, made by Human Genome Sciences Inc., is designed to lessen the severity of lupus, a little-understood disease in which the body's immune system attacks tissues and organs, producing skin rashes, joint pain, chronic fatigue and, in severe cases, heart and kidney complications.

Even though Benlysta has been shown to be only moderately successful in decreasing disease markers (an FDA advisory committee expressed some trepidation about its effectiveness last November), the dearth of other effective treatments makes Benlysta the hope of many a lupus researcher and patient.

"We still have a long way to go in understanding and treating lupus, but it's important to approve this right now. It really is the first drug for lupus to meet clinical endpoints [in decades]," says Dr. Betty Diamond, a lupus researcher who heads the Center for Autoimmune and Musculoskeletal Diseases at the Feinstein Institute.

Current standard of care for lupus includes high-dose steroids and anti-malaria medication to hamper the body's immune system. These medications can cause bone deterioration, infection, muscle weakness, ulcers and more, which, compounded with the symptoms of the disease itself, greatly hinder quality of life.

But even now that it has been approved, Benlysta will likely work in tandem with other lupus medications, and since Benlysta was not tested on patients with severe lupus in which the kidneys are heavily affected, it will most likely be prescribed only to those with mild to moderate disease.

Whether or not Benlysta will become the groundbreaking new treatment that many hope for, lupus experts were eager to see it approved.

"It's a long way from being a perfect drug, but I'll be interested to see if it can hold up as a usable drug," says Diamond.

Copyright 2011 ABC News Radio 


Researchers Look into Brains of Tumultuous Preteens

Jupiterimages/Thinkstock(LOS ANGELES) -- For many parents, their children's preteen years could be compared only to a rollercoaster ride.

Tumultuous, erratic emotions, and unpredictable behavior are just a part of adolescence, and many parents have learned to just strap on their seat belts and hold on tight.

But why are some adolescents more emotional and susceptible to risky behaviors, while others remain steadfast in the face of peer pressure?

Dr. Marco Iacoboni, a professor of psychiatry and biobehavioral sciences at UCLA medical school, raised just that question about his 14-year-old daughter. So Iacoboni and a team of researchers sought to answer what might make adolescents give in to their friends and take more risks.

"When [adolescents are] among a group of people, they to tend to follow what others do, and being able to control their own emotions and actions can be very important," said Iacoboni, who is also the director of the transcranial magnetic stimulation lab at the Ahmanson-Lovelace Brain Mapping Center at UCLA. The brain responses to emotional facial expressions, and would offer the first clue, he said.

Iacoboni and his colleagues took brain images of 38 adolescents over time as they were shown pictures of people expressing basic emotions, such as fear, happiness, sadness, anger, and neutrality. The researchers found that as the adolescents looked at faces expressing happiness or sadness, the area of the brain that expressed control over emotions showed increased activity.

The same group of adolescents reacted less emotionally to the other expressions, and the area of the brain associated with risk-taking and pleasure seeking lit up.

Previous research indicated that increased activity in the amygdala, an area deep in the brain, among preteens is associated with a higher likelihood of engaging in risky behavior, such as experimenting with drugs or sex.

"The assumption was more activity in there meant it was bad for the kids," said Iacoboni. "But we found higher activities and desires in other areas of the brain made them less prone to follow other kids."

Iacoboni and his researchers found that activity in the ventral striatum (VS), located next to the amygdala, also increased when the adolescents were shown more emotional photos.

"We saw there's an inverse activity relationship between the amygdala and the ventral striatum," said Iacoboni. "The VS activity increased while the amygdala activity slightly decreased, so the VS regulates the amygdala."

But could a test like this predict whether a preteen is more likely to act out or succumb to peer pressure? Iacoboni said it's still too early to tell.

The study didn't control for other factors in the adolescents' lives, such as socioeconomic status, current behavio, and life influences that could contribute to future behavior.

The adolescents were tested twice over two years, once at age 10 and again at age 13. The researchers plan to test the group once again when they're 16.

"The more we get these snapshots of how the brain changes over time, the more we'll be able to see how dynamic a young person's brain is," Iacoboni said. "With this information, we can potentially direct the brain in another course."

The research so far suggests that facial expressions and emotions directed at adolescents may influence their brain response and, potentially, how they act.

Perhaps parents who express -- or control -- their emotions around their preteens could influence the way they express or hold back their emotions around others, Iacoboni said.

"Sometimes staying neutral or apathetic is not the best choice, but don't be over emotional," he said. "You want to show warmth, because it'll be good for their social competence in life."

Copyright 2011 ABC News Radio


Study: Elderly Drivers Need More Traffic Signs

Hemera Technologies/Thinkstock(JERUSALEM) -- A new Israeli study says elderly drivers may need more traffic signs alerting them to the presence of pedestrian crossings and other potential hazards.

When drivers over 65 get behind the wheel, they're only half as likely to see pedestrians on the sidewalk as younger drivers, according to  researchers in Israel. They've concluded that the limited field of vision often found in the elderly significantly impairs their ability to detect pedestrian and other hazards while driving. Tested on a traffic simulator, they responded slower and hit the brakes 50% less than younger drivers.

To compensate, the study found the elderly drive slower -- up to 20% slower, in fact -- to give them more time to detect problems.

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