I have been a community and hospital pharmacist for over thirty years … trained in clinical pharmacy at one of the largest healthcare centers in the South.I am a consultant pharmacist for Medication Therapy Management (MTM) for the State of North Carolina.
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Allergan Inc. (AGN) said it has agreed to pay the U.S. government $600 million to settle criminal and civil charges related to U.S. sales and marketing of Botox.
The charges involve alleged marketing of the antiwrinkle treatment, best known for its use in cosmetic procedures, for uses not approved by the Food and Drug Administration, including headache, pain, spasticity and juvenile cerebral palsy. The product accounts for about a third of Allergan’s revenue and in the latest quarter saw sales grow 7% to $360.5 million.
The drug maker agreed to plead guilty to a misdemeanor “misbranding” charge, which indicates its labeling didn’t contain adequate directions for the treatment’s intended uses. Misbranding is known as a strict liability offense and doesn’t imply false or deceptive conduct. The company will pay $375 million in connection with the criminal settlement.
Allergan also said it has also agreed to pay $225 million to resolve civil claims asserted by the Justice Department under the civil False Claims Act.
The company expects to record fourth-quarter pretax charges of $610 million to $615 million in connection with the settlement.
“This settlement is in the best interest of our stockholders as it resolves all matters at issue in the investigation, avoids substantial costs of litigation, as well as the substantial risks to Allergan associated with government enforcement action in these matters, and permits us to focus our time and resources on productively developing new treatments for patients and the medical community,” said Douglas S. Ingram, Allergan’s executive vice president.
As part of the deal, Allergan will pay for third-party monitoring for five years of the company’s compliance efforts.
Studies of the safety, effectiveness, and biological action of botanical products are major focuses for the five dietary supplement research centers selected to be jointly funded by the Office of Dietary Supplements (ODS) and the National Center for Complementary and Alternative Medicine (NCCAM), two components of the National Institutes of Health. The NIH’s National Cancer Institute is co-supporting two of the five centers.
The competitive awards, approximately $1.5 million each per year for five years, were made to Pennington Biomedical Research Center, Baton Rouge, La.; University of Illinois at Chicago; University of Illinois at Urbana-Champaign; University of Missouri, Columbia; and Wake Forest University Health Sciences, Winston-Salem, N.C.
These five interdisciplinary and collaborative dietary supplement centers, known as the Botanical Research Centers (BRC) Program (http://ods.od.nih.gov/Research/BRCProgram), are expected to advance understanding of how botanicals may affect human health. “Eventually, the program may provide data that translates to new ways to reduce disease risk,” explained Paul M. Coates, Ph.D., director of ODS. “Until then, the research from these centers will help the public make informed decisions about botanical dietary supplements.”
“Botanicals are usually complex mixtures of many active constituents,” said Josephine P. Briggs, M.D., director of NCCAM. “This complexity poses some unique research challenges that these centers are well positioned to address.”
The 2007 National Health Interview Survey shows that about 18 percent of adults reported taking a non-vitamin, non-mineral, natural product, spending about $15 billion on the purchase of these products. These products contain a dietary ingredient intended to supplement the diet other than vitamins and minerals, such as single herbs or mixtures.
. CHARLOTTE, N.C. - 23-year-old SouthPark resident Cameron Crye says remembering to take her birth control pill every day at the same time is a pain. Crye says, “Personally, my friends have to set an alarm on their phone to remind them to take it!”
The UNC Charlotte student says she’d like a more convenient form of birth control, like the patch, but she’s wary of the estrogen levels found in patches already on the market. “One of my friends that used the patch that was a regular dose found that she had a lot of acne and was nauseated,” says Crye.
The “regular” dose patches expose the women who use them to 60% more estrogen than the pill. That increase can also mean an increase in serious health issues, like blood clots, strokes or heart attacks.
A new, low dose birth control patch will be tested here, at Metrolina Medical Research Center in SouthPark, on about 15 patients over the course of 1 year. It’s part of a nation-wide study that will include 1,500 women.
“I think they’re looking for convenience and safety and we think this offers both,” says Dr. George Raad. Raad’s patients will be required to visit the clinic often so he can check on how the low dose patch is working for them. “These are all visits that are mandated by the FDA to assess safety, which is number one.”
The company making the new patch, Agile Therapeutics, did a study in 2008 and found more than 30% of women are not happy with their current contraceptive methods, citing cost, side effects and convenience as their most common concerns. That assessment rings true with co-ed Crye. “It’s definitely a pain,” she says.
Again, the study will last one year. After that, Dr. Raad says there will be a few more trials. He expects the low-dose patch to be on the market in about three years.
Do you know why school kids get sick so often? The best ways to prevent illness in the classroom? Get the answers to these school health questions and more.
Does it seem as if your child is sick all the time? In the early school years, your child’s immune system is put to the test. After all, young children in large groups are breeding grounds for the organisms that cause illness. Here’s why infectious illness is so common — and what your child can do to stay healthy in the classroom.
How infections spread
Many childhood illnesses are caused by viruses. All it takes is a single child to bring a virus to school for the spread to begin. Consider this common scenario — a child who has a cold coughs or sneezes in the classroom. The children sitting nearby inhale the infected respiratory droplets and the cold spreads. Or perhaps a child who has diarrhea uses the toilet and returns to the classroom without washing his or her hands. Illness-causing germs might spread from anything the sick child touches to other children who touch the same object and then put their fingers in their mouths.
Monitoring health problems after vaccination is essential to ensure the United States continues to have the safest, most effective vaccine supply in history.
CDC’s Immunization Safety Office identifies possible vaccine side effects and conducts studies to determine whether a health problem is caused by a specific vaccine.
You may have heard the U.S. Surgeon General’s recommendation of 30 minutes of physical activity a day. This is intended for people who want to maintain the most basic level of fitness — but not for people who want to lose weight. In a week, 30 minutes a day works out to an expenditure of about 1,000 calories, which is fine if you are looking to maintain your current weight. But if you want to lose, you’re going to have to be prepared for a bit more work.
I much prefer the World Health Organization’s recommendation of 60 minutes at a time as a starting point for my clients — an hour is ideal to get the most out of your workout and see significant results. Your 60-minute workout sessions should always include a 5-minute warm-up, followed by 50 minutes of your primary cardio or strength-training exercises, followed by at least 5 minutes of cooling down and stretching.
Of course, putting in more time will get you more results — but there’s a limit. Excessive intense physical activity releases stress hormones, such as cortisol, into the body. This can actually inhibit weight loss, causing your body to react by storing fat and retaining water out of self-protection. So, to reach your goal, I recommend limiting intense exercise to no more than two hours a session.
NIH Funded Study Deciphers Chemical Sequence of Nerve Regeneration in Rats
The vitamin folate appears to promote healing in damaged rat spinal cord tissue by triggering a change in DNA, according to a laboratory study funded by the National Institutes of Health.
The researchers showed that the healing effects of the vitamin increased with the dosage, until regrowth of the damaged tissue reached a maximum level. After this threshold was reached, regrowth declined progressively with increasing doses until it reached the level seen in the absence of the vitamin.
Specifically, folate stimulated a process known as DNA methylation, a natural biochemical process in which chemical compounds known as methyl groups are attached to DNA. The study results suggest that a greater understanding of the chemical sequences associated with folate metabolism and DNA methylation may lead to new techniques to promote healing of damaged spinal cords and other nervous system injuries.
The research is at an early stage and additional studies are needed to determine what role folate might play in the treatment of human beings with spinal cord injury. Information about folate in human nutrition, including dietary sources of the vitamin and appropriate daily intake is available from the folate fact sheet(http://ods.od.nih.gov/factsheets/folate.asp) of the NIH Office of Dietary Supplements (http://ods.od.nih.gov/factsheets/folate.asp).
The research was supported by the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Dental and Craniofacial Research, and National Institute of Neurological Disorders and Stroke. The findings were published in the Journal of Clinical Investigation.
In February, the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention (CDC) on vaccine guidance, made a landmark decision establishing a universal influenza vaccine recommendation, starting with the 2010–11 influenza season. This means that all people in the United States—excluding babies younger than age six months and people with certain medical conditions—are now recommended to receive influenza vaccine every year.
The new recommendation is simple, straightforward, and easy to communicate. It eliminates the complexities of the prior recommendations, which said people should be vaccinated if they fell into any of 15 different targeted groups (a lengthy list to commit to memory). Going forward, healthcare professionals will have a very easy time deciding which of their patients are recommended for influenza vaccine. And patients will eventually come to recognize that influenza vaccine is routinely recommended for them. Now, the message is simple: everyone, every year, unless specifically contraindicated.
Here at the Immunization Action Coalition, we welcome this change. We think it will erase any uncertainties healthcare professionals and their patients may have had about who should be vaccinated, and will lead to more people than ever protecting themselves, their families, and their communities by getting immunized.
A healthy body image is an important part of a growing girl’s self-esteem. Understand what you can do to help your daughter feel comfortable with her body.
Girls today face significant pressure to be physically attractive and have a perfect body. As a result, many girls feel dissatisfied with their bodies and are at higher risk of developing mental health problems. There are steps you can take, however, to encourage your daughter to love her body, regardless of its shape or size. Find out what you can do to help girls develop and maintain a healthy body image.
Causes of a negative body image
Maintaining a healthy body image during adolescence is often difficult for girls. Factors that may harm a girl’s body image include:
Having a mother who’s overly concerned about her own weight or her daughter’s weight or appearance
Natural weight gain and other changes caused by puberty
Peer pressure to look a certain way
Media images that promote the ideal female body as thin
Being teased about her weight
Consequences of a negative body image
If your daughter doesn’t feel she lives up to the ideal body image promoted by friends, family and the media, she may begin to feel inadequate and ashamed of her body — even if she’s not overweight. Girls who feel dissatisfied with their bodies are at higher risk of developing mental health problems, including:
Low self-esteem
Depression
Eating disorders
Having a negative body image also may lead to skipping meals or a cycle of dieting, losing weight and regaining weight — which can further harm self-esteem. A negative body image may even result in a desire for cosmetic surgery. Some research suggests a link between body dissatisfaction among girls and cigarette smoking, possibly because girls may believe that smoking will help them control their weight. Having a negative body image also may affect a girl’s comfort with her sexuality as she grows.
Bob Diamond R.Ph
