'Sexting' Linked to Sex in Middle School

MONDAY June 30, 2014, 2014 -- Middle school students who send sexually explicit text messages and photos to one another are more likely to have sex than those who don't "sext," a new study finds.

A survey of young teens in Los Angeles found that 40 percent who'd sent explicit messages or photos said they'd been sexually active compared to just 5 percent of other kids with cellphones that could display text messages.

"The surprise is that for younger kids -- 11- to 13-year-olds -- sexting is not an alternative to real-life sexual activity. It's actually a part of it," said study author Eric Rice, an assistant professor at the University of Southern California, Los Angeles.

"Also, kids who reported 100 or more text messages per day were much more likely to report sexting, so being an excessive texter may be an indication of risky behaviors," Rice added.

"Sexting" refers to sexually explicit messages sent via computer or cellphone -- in this case with or without images. Some sexts may just be explicitly flirtatious, while others include nudity.

Experts disagree about the level of risk posed by "sexting," and there's no definitive proof that the electronic messages are a gateway to early sexual activity.

"Sexting isn't harmful unto itself, but it can have harmful implications," Rice said. "It can ruin reputations and cause legal problems and may encourage kids to be more sexually active."

For the study, researchers surveyed more than 1,300 students aged 10 to 15 in the Los Angeles school district in 2012. Among those who answered questions about their ethnicity and sexuality, 60 percent were Latino and 96 percent were heterosexual.

The researchers adjusted their statistics so they'd better reflect the ethnic makeup of the school district.

More than two-thirds of the students owned their own cellphone. Three-fourths had access to a cell phone that could display text messages, according to the study, published online June 30 and in the July print issue of the journal Pediatrics.

Only a minority of kids with access to texting admitted to sexting. Twenty percent said they'd received a sexually explicit message or photo, and 5 percent said they'd sent one.

But young teens who received sexts were six times more likely to report having had sex, defined as either oral, vaginal or anal intercourse, according to the study.

Those who sent sexts were about four times more likely to report sexual activity.

The study has caveats, however. For one thing, self-reported information may be biased. "Sexual behavior is notoriously difficult to measure because you're relying on people reporting about themselves," said Amy Hasinoff, an assistant professor at the University of Colorado, Denver, who studies sexting.

Hasinoff cautions parents not to worry excessively about kids who spend a lot of time texting. "I don't know that texting a lot is a particular problem," she said.

"We need to think of cellphones as a way that kids communicate. You'd never say kids are talking to their classmate too much at recess, or that they used 1,000 words at recess, and that's excessive," she added.

What should parents do?

"Start talking to your kids about sexting early. If you suspect that your child is sexting, be aware that he or she is probably also sexually active," study author Rice said.

"Remember that teen pregnancy and sexually transmitted diseases can be prevented, but teens need to be educated in thoughtful ways by parents, teachers and pediatricians," Rice added.

The study says parents may wish to "openly monitor" their kids' cellphones. But Hasinoff said "that sends the exact wrong message."

Parents should talk about the importance of privacy and serve as role models, she said. "We want to be teaching kids to respect the privacy of other kids and develop the sense that privacy really matters," she explained.

Kids should also learn about the need to gain consent for any kind of sexual behavior, including sending someone sexually explicit photos, she added.

More information

The American Academy of Pediatrics has more about how to discuss sexting with your teen.

Posted: June 2014

Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients

Audience: Consumer

Including:

Sport Burner (contains fluoxetine)
Toxin Discharged Tea (contains fluoxetine)
Sliming Diet (contains sibutramine)[Posted 06/19/2014]

ISSUE: FDA is advising consumers not to purchase or use these products, promoted and sold for weight loss on various websites and in some retail stores. FDA laboratory analysis confirmed that these products contain sibutramine or fluoxetine.

Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Fluoxetine is an FDA approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD). Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.

RECOMMENDATION: Consumers should stop using these products immediately and throw them away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

[06/19/2014 - Tainted Weight Loss Products - FDA]

When Is the Cost of Cancer 'Toxic'?

FRIDAY June 20, 2014, 2014 -- A tool to assess "financial toxicity" for cancer patients -- namely, the expense, anxiety and stress of illness-related costs -- has been developed by University of Chicago Medical Center cancer specialists.

Many cancer patients face exorbitant and unpredictable treatment costs often at a time when they're less able to work, the researchers point out.

"Few physicians discuss this increasingly significant side effect with their patients," study author Dr. Jonas de Souza, a head-and-neck cancer specialist, said in a university news release. "Physicians aren't trained to do this. It makes them, as well as patients, feel uncomfortable. We aren't good at it."

According to de Souza, "a thoughtful, concise tool that could help predict a patient's risk for financial toxicity might open the lines of communication."

The team developed a brief questionnaire after discussions with 150 patients with advanced cancer, according to the study in the July issue of the journal Cancer.

For each of the 11 questions -- such as "My out-of-pocket medical expenses are more than I thought they would be" or "I am not able to meet my monthly expenses" -- patients choose from five potential responses: not at all, a little bit, somewhat, quite a bit, or very much.

The patients' answers help health care providers identify those who may require assistance such as financial counseling or referral to a support network.

"We need better ways to find out which patients are most at risk," de Souza said. "Then we can help them get financial assistance. If patients know what to expect, they may want their physicians to consider less costly medications."

The cost of cancer care in the United States is rising faster than the cost of overall health care, the researchers said. Also, the cost of new cancer drugs is increasing more rapidly than the cost of overall cancer care, they added.

Annual medical costs increase by more than $4,000 for male cancer survivors and by nearly $3,300 for female cancer survivors, according to a recent study from the U.S. Centers for Disease Control and Prevention.

Meanwhile, about 30 percent of cancer survivors can't return to work or are less able to work, according to the CDC.

More information

The American Society of Clinical Oncology has more about cancer costs.

Posted: June 2014

Sanofi's Lyxumia (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering than Liraglutide when Both were Added to Insulin Glargine

PARIS, June 14, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that Lyxumia® (lixisenatide) met the primary endpoint in an 8-week head-to-head pharmacodynamic study versus liraglutide, showing a significantly more pronounced post-prandial (after-meal) glucose (blood sugar) lowering effect after a test-meal than liraglutide when both were added to optimally titrated Lantus® (insulin glargine). Lowering of post-prandial glucose was measured as change from baseline in incremental area under the glucose curve for 4 hours after a standardized solid breakfast, at week 8.

Findings also showed that while both lixisenatide and liraglutide lowered blood glucose (HbA1c) when added to optimally titrated insulin glargine, lixisenatide treatment resulted in fewer reports of gastrointestinal adverse events, a lower mean increase in heart rate and smaller increases from baseline to week 8 in pancreatic enzyme (amylase and lipase) levels. The most commonly reported adverse events in the study were symptomatic hypoglycemia and nausea. Symptomatic hypoglycemia was more frequent in the lixisenatide group compared to the liraglutide group. (Full results are available in the Results of Analysis section.) Lixisenatide is currently approved in Europe and an investigational drug in the United States, where it is not approved.

"In this Phase II head-to-head study we saw a significant difference in the post-prandial glucose lowering effects of lixisenatide and liraglutide, two GLP-1 receptor agonists, with similar overall blood sugar reductions," said Riccardo Perfetti, Senior Medical Officer, Vice President Global Medical Affairs, Diabetes Division, Sanofi. "The results showed that both medicines reduced blood glucose, but we found that lixisenatide did this with a greater delay in gastric emptying, and its use was associated with differences in safety and tolerability compared to liraglutide. These differences are interesting and could be further explored to determine whether differences in gastric emptying benefit patients by lowering the post-prandial glucose excursion and whether gastric emptying corresponds to differences in safety and tolerability."

These results were presented at the 74th Scientific Sessions of the American Diabetes Association, San Francisco, CA. The abstract is titled: Effect of Lixisenatide vs Liraglutide on Glycemic Control, Gastric Emptying, and Safety Parameters in Optimized Insulin Glargine T2DM +/- Metformin. (Meier et al. Poster presentation #1017-P, June 14, 2014).

About Lixisenatide

In Europe, Lyxumia® (lixisenatide) is approved as a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. It remains under investigation in the U.S. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com, and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lyxumia is currently approved in over 40 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in Europe, Japan, Mexico and other markets. Sanofi plans to resubmit the New Drug Application for lixisenatide in the United States in 2015, after completion of the ELIXA cardiovascular outcomes study. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide.

The Lyxumia pen is the winner of a number of innovative design awards, including the Good Design Award 2012 and the iF Product Design Award. The variant of the Lyxumia pen used in Japan won the Good Design Award (G Mark) 2013.

Can Weight-Loss Surgery Lower Cancer Risk for the Obese?

Monday June 15  2014, 2014 -- Weight-loss surgery may do more than lower the risk of heart problems and improve type 2 diabetes in obese patients: A new review suggests it may also lower their chances of a cancer diagnosis.

"Bariatric surgery is associated with reduced cancer risk in morbidly obese people [to that of normal-weight people]," the team of Brazilian researchers wrote. Their report was published recently in the journal Obesity Surgery. A morbidly obese person is roughly 100 pounds overweight, with a body-mass index (BMI) of 40 or higher.

Cancer experts in the United States who reviewed the findings were not completely convinced that surgery can reduce cancer risk to that of normal-weight people. But they agreed that obesity raises the risk of certain cancers.

The Brazilian researchers, from the Hospital Sao Lucas in Porto Alegre and other institutions, pooled the results of 13 studies including more than 54,000 people. Each study looked at cancer rates after weight-loss surgery.

Cancer rates in obese people are as high as two per 1,000 person-years (the number of years times the number of people in a population affected by a certain illness).

However, in those who had the surgery, the researchers found the rate was about one per 1,000 person-years, or nearly that of normal-weight people. The follow-up ranged from two to 23 years after the surgery.

Bariatric surgery is performed on the stomach and/or intestines to help with weight loss. Various approaches are used.

The risk reduction with weight loss surgery is "probably true," said Dr. Cy Stein, chair of medical oncology and experimental therapeutics at the City of Hope Medical Center in Duarte, Calif.

It would make sense, he said, since "the evidence that obesity is related to an increased risk of cancer is significant, even in the modestly obese. There is an association [between obesity and cancer]. It is a risk factor for cancer development."

According to the American Cancer Society, an estimated one of three cancer deaths in the United States is linked to excess weight, poor diet and/or inactivity. The link between weight and cancer is strongest, the society says, for breast cancer in women past menopause, colon and rectal cancers, and cancers of the esophagus, kidney, pancreas and uterine lining (endometrium).

Even so, another cancer expert who reviewed the finding recommended "taking it with a grain of salt and a little bit of hesitation."

"I would say overall the evidence appears [to show] there is a reduction in risk," said Lauren Teras, director of hematologic cancer research at the American Cancer Society. "It's just hard to say for certain."

Even the researchers suggest that the conclusion should be viewed with care, since the studies they reviewed differed in the way they were conducted, potentially affecting results. Also, the review was not designed to determine a cause-and-effect link.

How to explain the apparent association between obesity and cancer?

"I think there is some good evidence that hormones play a role," Teras said. For instance, fat tissue is the largest source of estrogen in women past menopause, and that is thought to be linked with the type of breast cancer that needs estrogen to grow.

Another possible connection, she said, is inflammation. As people gain more and more weight, they have an increase in inflammation, and that may help tumors grow and spread.

"We're not sure if the obesity causes the cancer," Stein said, "but it may promote it."

Teras offered one more caveat: "Weight-loss surgery, like any surgery, is not without risks. The risks and benefits should be weighed with a person's individual doctor."

More information

To learn more about the obesity-cancer link, visit American Cancer Society.

Posted: June 2014

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Scientists Reverse Type 1 Diabetes in Mice

SUNDAY June 15, 2014, 2014 -- Scientists who reversed type 1 diabetes in mice say their results might lead one day to new ways to help people with the blood sugar disease.

Type 1 diabetes accounts for about 5 percent of all diabetes cases and is typically diagnosed in children and young adults. There is no cure for the disease, but it can be controlled by taking insulin.

In type 1 diabetes, immune system T-cells attack insulin-producing beta cells. In this study, University of Cincinnati researchers found that using an antibody called UT18 to stimulate a molecule called TLR4 prevented T-cells from attacking beta cells.

This approach reversed type 1 diabetes in a large percentage of non-obese mice that had just developed the disease, according to the study, which was to be presented Saturday at an American Diabetes Association meeting in San Francisco. Research presented at meetings has not been subjected to the peer-review process that most medical journals use, so it should be viewed as preliminary.

The key to reversing type 1 diabetes in mice is to catch the disease when it first develops, study leader Dr. William Ridgway said. He noted that the window of opportunity for treatment would be longer in humans, but would still be relatively brief. However, animal research findings often do not pan out in human trials.

This approach is different from most attempts to combat type 1 diabetes in that it does not directly target T-cells, according to Ridgway.

He said the therapy holds promise because one drug has already been approved by the U.S. Food and Drug Administration and others are under development.

More information

The U.S. National Library of Medicine has more about type 1 diabetes.

Posted: June 2014

Low Cholesterol Levels May Spell Trouble for Kidney Cancer Patients

THURSDAY June 12, 2014, 2014 -- Low cholesterol levels may increase kidney cancer patients' risk of death, a new study suggests.

The findings indicate that cholesterol testing may help guide treatment for kidney cancer patients, the study authors said.

They analyzed cholesterol levels in 867 kidney cancer patients before they had surgery for their cancer and followed them for a median of 52 months after surgery. Low cholesterol levels before surgery were associated with more advanced cancer and greater cancer spread after surgery.

The investigators also found that patients with high cholesterol levels were 43 percent less likely to die after surgery than those with low cholesterol levels, and that assessing cholesterol levels improved the accuracy of patients' prognoses.

While the study found an association between low cholesterol levels and a raised death risk among kidney cancer patients, it did not prove a conclusive link between the two.

It's not clear how cholesterol levels may affect kidney cancer patients' chances of survival, but certain components of cholesterol may influence tumor growth and spread, according to the authors of the study published June 12 in the journal BJU International.

"As this was a hypothesis-generating study, our findings should be confirmed in [future research]. If confirmed, patients with low cholesterol may be considered high-risk and may be treated or followed up more aggressively," Dr. Tobias Klatte, of the Medical University of Vienna in Austria, said in a journal news release.

More information

The U.S. National Library of Medicine has more about kidney cancer.

Posted: June 2014

Mylan Launches Generic Actonel Tablets, 150 mg

PITTSBURGH, June 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Risedronate Sodium Tablets USP, 150 mg, the generic version of Warner Chilcott's Actonel® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Risedronate Sodium Tablets USP, 150 mg, had U.S. sales of approximately $171.6 million for the 12 months ending March 31, 2014, according to IMS Health.

Currently, Mylan has 303 ANDAs pending FDA approval representing $105.3 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.

Posted: June 2014

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Men Feel More Pain After Major Surgeries, Study Finds

TUESDAY June 3, 2014, 2014 -- Gender may play a part in how much pain a patient feels following surgery, new research suggests.

An Austrian study involving more than 10,000 people found that men experience more pain after major surgery, while women report feeling more pain following minor procedures, such as biopsies.

"The influence of gender and sexes is a key issue of today's research in medicine. However, current literature in the field of perioperative medicine rarely focuses on this question," study co-author Dr. Andreas Sandner-Kiesling, of the department of anesthesiology & intensive care at the Medical University of Graz, Austria, said in a university news release.

"Our aim was to analyze a large population to find differences in postoperative pain perception in females and males," Sandner-Kiesling explained.

The patients involved in the four-year study were interviewed 24 hours after surgery. Of the patients surveyed, 42 percent were men and 58 percent were women. They were asked about their operation, the anesthesia they received and their pain and well-being.

Although gender didn't have an effect on pain after surgery overall, when the researchers grouped the patients with similar types of surgeries they found it did play a significant role.

The study, which was scheduled to be presented Tuesday at the Euroanaesthesia meeting in Stockholm, revealed that men were 27 percent more likely to have more moderate pain after major vascular and orthopedic surgery. Meanwhile, women were 34 percent more likely to report more pain after minor procedures.

"The gender differences on pain perception are still heavily disputed, both in experimental and clinical fields. Our data do not definitely clarify this issue; however, based on our findings it can be presumed that the type (and severity) of surgery may play a pivotal role," the study authors wrote.

Research presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.

More information

The American Academy of Family Physicians has more about controlling pain after surgery.

Posted: June 2014