Monday, September 10, 2012

Testosterone marketing frenzy draws skepticism‎


"Are you falling asleep after dinner?" "Do you have a decrease in libido?" "Have you noticed a recent deterioration in your ability to play sports?" "It could be Low-T."

Welcome to the latest marketing push by the nation's drug companies.

In this case, it's a blog for Abbott Laboratories' Androgel, a billion-dollar selling testosterone gel used by millions of American men struggling with the symptoms of growing older that are associated with low testosterone, such as poor sex drive, weight gain and fatigue.

Androgel is one of a growing number of prescription gels, patches and injections aimed at boosting the male hormone that begins to decline after about age 40. Drugmakers and some doctors claim testosterone therapy can reverse some of the signs of aging -- even though the safety and effectiveness of such treatments is not clear.

Low testosterone is the latest example of a once-natural part of getting old that has become a target for medical treatment. Bladder problems, brittle bones and hot flashes have followed a similar path: from inconvenient facts of life, to ailments that can be treated with drugs. The rise of such therapies is being fueled by both demographics and industry marketing.

Baby boomers are living longer and looking for ways to deal with the infirmities of old age: Life expectancy in the U.S. today is 78 years, up from 69 years a half-century ago. And companies have stepped up their marketing to the older crowd: Spending on print and television ads promoting testosterone by firms like Abbott and Eli Lilly has risen more than 170% in the last three years to more than $14 million in 2011, according to advertising tracker Kantar Media.

Doctors say that's led to an increase in men seeking treatment for low testosterone. Prescriptions for the hormone have increased nearly 90% the past five years, according to IMS Health. Last year, global sales reached $1.9 billion.

"People are living longer and want to be more active," says Dr. Spyros Mezitis, a hormone specialist at Lenox Hill Hospital in New York. "They no longer consider that because they're older they shouldn't have sexual intercourse."

Former marathon runner Damon Lease, 50, had been complaining of low energy and depression, for which his doctor prescribed a combination of four psychiatric drugs. But since he started taking twice-a-week testosterone injections in May, he says he's been able to stop taking two of the medications and hopes to eliminate them completely. He says he has more energy, improved mood and concentration.

"I spent 27 years running long distances, I like biking, I like hiking, and I guess every guy wants to have an active sex life ... I want to keep doing those things as long as I can," says Lease, who works as a software company executive. "I feel 20 years younger."

MASS-MARKET HORMONE

Despite its rising popularity, testosterone therapy is not completely new. Testosterone injections were long used for men with hypogonadism, a disorder defined by low testosterone caused by injury or infection to the reproductive or hormonal organs.

But the latest marketing push by drugmakers is for easy-to-use gels and patches that are aimed at a much broader population of otherwise healthy older men with low testosterone, or androgen deficiency. The condition is associated with a broad range of unpleasant symptoms ranging from insomnia to depression to erectile dysfunction. Drug companies peg this group at about 15 million American men, though federal scientists do not use such estimates.

Watson Pharmaceuticals now markets its Androderm patch, which slowly releases testosterone into the bloodstream. Abbott has its gel that can be applied to the shoulders and arms. And Eli Lilly's Axiron is an underarm gel that rolls on like deodorant. Androderm, launched last year, had $87 million in sales, and Axiron, which was launched in 2010, had sales of $48 million last year.

"All of a sudden you've got these big players with a lot of money using consumer directed marketing to change the landscape," said Dr. Natan Bar-Chama, a male reproductive specialist at Mount Sinai Hospital in New York. "They see the potential, they see the market growth annually and it's very impressive."

But government researchers worry that medical treatments have gotten ahead of the science.

Male testosterone is mainly produced in the testes and affects muscle mass, sperm production and various sexual characteristics. The hormone can easily be checked with a blood test, but doctors can't agree on what constitutes a low reading in older men. Typical testosterone levels for younger men range between 300 and 1,000 nanograms per deciliter, but once levels begin dropping there is little consensus on what makes a "normal number."

Some doctors believe testosterone levels below 300 lead to sexual dysfunction in older men, but the rule does not cover all cases. A 2010 study by researchers at the University of Manchester and other European institutions found that 25% of men with testosterone levels above that threshold had the same sexual problems used to diagnose low testosterone. Adding to the ambiguity is that testosterone levels change by the hour, so a man who takes a blood test for testosterone in the morning may get a completely different reading when tested in the afternoon.

SAFETY CONCERNS

Adding to the confusion over what defines "low testosterone," there's not much understanding of whether testosterone replacement therapy actually improves men's symptoms. Evidence of the benefits of testosterone is mixed, and the potential health risks are serious. The largest study conducted to date, a 2008 trial involving 230 patients in the Netherlands, found no improvement in muscle strength, cognitive thinking, bone density or overall quality of life among men taking testosterone. Muscle mass increased 1.2%, but not enough to improve physical mobility.

The National Institute on Aging is currently conducting an 800-man trial to definitively answer whether testosterone therapy improves walking ability, sexual function, energy, memory and blood cell count in men 65 years and older. But those results aren't expected until 2014.

In addition to concerns about testosterone's effectiveness, the long-term side effects of the hormone are not entirely understood because most trials to date have only followed patients for a few months. But the most serious risks include heart problems and prostate cancer.

In 2010, researchers at Boston University's school of medicine halted a large study of testosterone in senior men because patients taking the hormone were five times more likely to suffer a serious heart event, including congestive heart failure, than those taking placebo. A review of 19 testosterone trials in 2006 found that prostate cancer was significantly higher among men taking testosterone. All testosterone drugs carry a warning that the hormone should not be given to men who have a personal or family history of prostate cancer.

Also in 2006, the Endocrine Society published the first physician guidelines for prescribing testosterone for men with androgen deficiency. All six of the co-authors had received consulting fees or research funding from drugmakers that market testosterone. Despite those ties, the authors took a cautious tone, stressing the difficulty of accurately diagnosing low testosterone and acknowledging that they were unable to reach an agreement about when doctors should begin therapy. They also recommend doctors have an "explicit discussion of the uncertainty about the risks and benefits of testosterone therapy."

History has shown that hormone replacement therapy can be dangerous. That hit home for women in 2002 when a landmark study shook up the conventional wisdom about the benefits of estrogen replacement therapy for menopause, the period when women stop producing eggs and estrogen. The federal study found that women taking hormone pills were more likely to suffer heart attacks, breast cancer and strokes. Doctors now generally recommend hormones only to relieve severe menopause symptoms รข?? in the lowest possible dose and for the shortest possible time.

In the case of testosterone, Abbott Laboratories says Androgel and other drugs like it are an important treatment option for men with low levels of the hormone. But the company acknowledges that more study is needed.

"Abbott believes that the long-term effects of testosterone replacement therapy should be studied, which is why we continually fund and support additional clinical trials, such as the National Institute of Aging's testosterone trial," the company states.

Doctors who prescribe testosterone say more men should be talking to their doctors about the hormone. "If an older man feels excessively tired or his erectile dysfunction has worsened he should be asking 'is there something wrong with my testosterone?'" says Mezitis of Lenox Hill Hospital. "The awareness should be much broader than it is at this point."

And even critics of the testosterone craze acknowledge that the interest in anti-aging products may be inevitable as life expectancy increases. But they say doctors can do more to help seniors by focusing on lifestyle adjustments that keep them connected to their friends and family, rather than prescribing drugs.

"We really medicalize seniors so much that they think the secret always has to be scientific," says Dr. Nortin Hadler of the University of North Carolina at Chapel Hill, who has written four books on excessive medical care. "We need another perspective to understand the secrets to healthy aging, which by and large are not pills."

Life Without Guilt

There is no emotion so utterly unnecessary as guilt. Many people, to be sure, would find this statement absurd. Just look, they would argue, at the guilt-ridden faces of shoppers who know their accounts are overdrawn, at the obese who know they should not finish off that last piece of pie or at the moralist surfing for Internet porn when he knows that it corrupts. These are very good points. Nevertheless, guilt is a useless emotion.

The need for guilt exists because people happily do exactly what they wany while ignoring responsibility for their actions. They want pizza without calories, sex without betrayal, war without victims. Guilt's presence is concomitant with our urge to be irresponsible.

Since human beings first lifted their eyes to the flaming sun, there has been excess and debauchery, treachery and murder. Gods, saints and priests as well as kings, parliamentarians and teachers have made the rules that people have always gleefully disregarded -- feeling guilty all the way but undeterred by society's frowns, prison's solitude or hell's flames. Energetically, we continue to do evil; there is no sign of abatement.

We live in a world of pain. We enter it screaming, after a wicked whack on our bottoms. Screaming or whimpering, we leave it. Why should guilt accompany us on this long-arching journey from womb to tomb? What service does it provide?

The only possible purpose of this delusive emotion should be its corrective, reflective or, ideally, preventative potential. And yet all societies across the globe are busily engaged in guilt-producing deeds. And if these guilty actions are repeated -- which they virtually always are -- then the reasons for experiencing guilt vanish.

Guilt is as beguiling as it is harmful, a cozy, clammy blanket smothering our consciences. It produces no significant change in behavior or character, heals no wounds, fills no internal voids, provides no insight, rights no wrongs. It always arrives after the fact, preventing nothing.


Because guilt is always connected with pleasure-giving acts, it is perverse. Unable to change human behavior, it is ineffectual. Reproduced a millions times over, it is irrelevant. Only by embracing our humanity and by living in full awareness of the decisions we make, and the results arising from them, may we live without this subconsciousness hidden burden. Surely we should rely on  those rare things that make gives us satisfaction. Surely we should experience the full, rich range of our emotions. And surely we can live freer lives without the dead weight of guilt.

Sunday, September 9, 2012

Kids' temper sign of mental health problem

For the new study, funded by the National Institute of Mental Health, researchers developed the new questionnaire, the Multidimensional Assessment of Preschool Disruptive Behavior (MAP-DB), to ask parents of almost 1,500 diverse preschoolers, age three to five, to answer questions about their child's behaviour.

In this new study, researchers have given parents and professionals a new tool to know when to worry about young children's misbehaviour.

Researchers from Northwestern University Feinberg School of Medicine have developed an easy-to-administer questionnaire specifically designed to distinguish the typical misbehaviour of early childhood from more concerning misbehaviour.

The results allowed researchers to rate children along a continuum of behaviour from typical to atypical, rather than focusing only on extreme behaviour.This will also enable early identification and treatment of emerging mental health problems, key to preventing young children struggling with their behaviour from spiralling downward into chronic mental health problems.


In a surprising key finding, the study also debunks the common belief that temper tantrums are rampant among young children.

Although temper tantrums among preschoolers are common, they are not particularly frequent, the research shows.

Less than 10 percent of young children have a daily tantrum. That pattern is similar for girls and boys, poor and non-poor children and Hispanic, white and African-American children.


"It gives a measurable indicator to tell us when tantrums are frequent enough that a child may be struggling. Perhaps for the first time, we have a tangible way to help parents, doctors and teachers know when the frequency and type of tantrums may be an indication of a deeper problem," he said.

Until recently, the only diagnostic tools available for preschool behaviour problems were those geared to older children and teens with more severe, aggressive behaviour.

More recently, there has been emphasis on measures developed specifically for preschool children.


The study has been published in The Journal of Child Psychology and Psychiatry.

Children 'need more teaching on cancer causes


Children are not aware of what causes cancer, with a small number believing they can get it from behaving badly, suggests a poll by Macmillan Cancer Support.

The survey of 500 children aged between nine to 16-years-old found that 97% do not know that sunburn can cause cancer - although 91% do know smoking causes it.

The charity says the results suggest children are less informed about cancer.

School teachers need to educate children on cancer, it adds.

The children who responded to the poll also do not know what it means to have cancer.

One in five think it is always fatal, while more than half say they do not know what it is.

And 4% even think cancer can be caught from someone else..

Frightening


Despite this, during poll, only two-thirds of the children know someone who has been diagnosed with cancer, though more than half say the word 'cancer' makes them feel frightened.

Katherine Donnelly from Macmillan Cancer Support said many people, including teachers, think that young children should be avoided from talking about cancer.

"In many ways, it's still a bit of a taboo subject. Not all teachers feel confident about talking about it or know where to get the facts and figures from.

"The results showed that as children got older there was a slight increase in the number of those that had been taught about cancer, but not a hugely significant number."

Miss Donnelly added: "As cancer affects more and more people, the chances of children knowing someone with the condition grows - be that their grandparent, parent or friend. This can be really distressing and they may feel too worried to ask questions.

"Just over a quarter of children have been taught about cancer at school and this needs to improve."

The charity has produced an information pack called Talking About Cancer to allow teachers to plan lessons around the subject.

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How Alcohol Affects Your Body


HYDRATION

Alcohol depresses the production of antidiuretic hormone (ADH), which helps keep you hydrated. Dehydration can lead to electrolyte imbalances (characterized by nausea, dizziness and diarrhea) and headaches.

BREASTS

According to a 2009 study in the Journal of the National Cancer Institute, one alcoholic drink a day can increase the risk of breast cancer. Researchers believe alcohol boosts risk of breast cancer by increasing estrogen levels, a well known risk factor for breast cancer. Other theories: alcohol reduces the liver’s ability to clear cell-damaging toxins and depletes the body of cancer-protective antioxidants, such as folate and vitamin C.

STOMACH

Alcohol causes stomach cells to produce excessive amounts of gastric acid, which can irritate the stomach. 

PANCREAS

Heavy alcohol use is the common cause of pancreatitis, an inflammation of the pancreas and a major risk factor for pancreatic cancer.

LIVER

Drinking excessively causes the liver to accumulate fat (fatty liver) and become inflamed (hepatitis). It also leads to cirrhosis, a condition in which liver cells are so damaged they can’t regenerate, and liver failure.
Take note: having as few as 3 drinks at once can cause liver damage if mixed with certain medications—including acetaminophen and statin drugs used to treat high cholesterol. If you take any prescription or over-the-counter drugs, ask your doctor or pharmacist whether it’s safe to consume alcohol.

BRAIN

Moderate alcohol consumption may ward off dementia and Alzheimer’s disease. As we age, brain cells die, leading to gaps that slow nerve transmission within the brain and between the brain and the rest of the body. Moderate drinking appears to somehow prevent these “potholes.” (Scientists aren’t sure why.)
In high doses, alcohol kills brain cells, leading to brain damage that may manifest itself as permanent memory loss. Heavy drinking may even change the brain in ways that contribute to strained personal relationships. In a study in the November 2009 issue of Alcoholism: Clinical & Experimental Research, alcoholics registered decreased activity in parts of the brain responsible for recognizing people’s facial emotions, which may contribute to miscommunication and conflict, say researchers.

HEART

Drinking in moderation may protect the heart by raising “good” HDL cholesterol, decreasing inflammation and “thinning the blood” (preventing clots that can cause heart attack and stroke). Moderate drinking also increases estrogen, which protects the heart—a benefit particularly helpful to postmenopausal women whose reduced estrogen levels increase their risk of heart disease.

BLOOD PRESSURE

Drinking even in moderate amounts (particularly on an empty stomach) has been linked to high blood pressure, a risk factor for heart attack and stroke.

BONES

Moderate alcohol consumption may boost bone density and reduce risk of bone fractures, possibly by raising levels of sex hormones like estrogen and testosterone, which help to keep bones strong. Wine and beer may be more beneficial than liquor because they contain compounds (e.g., resveratrol in wine and silicon, a trace mineral, in beer) that may also contribute to bone density, according to a 2009 study in the American Journal of Clinical Nutrition.
Excessive alcohol intake may increase risk of osteoporosis and bone fractures by accelerating the rate of bone deterioration. Alcohol, a diuretic, also flushes calcium—a mineral essential for strong, dense bones—from the body.

Friday, September 7, 2012

Oldest U.S. Mom of Twins Is 65 and 'More Excited' Than Ever


When it comes to taking motherhood to an extreme, Frieda Birnbaum is unparalled -- literally. In 2007, at age 60, she became the first oldest American woman to give birth to twins.

Today, at age 65, the New Jersey woman says she's still going energetic, chasing after her two five-year-old boys -- Josh and Jarrett -- and also caring for her 12-year-old son, Ari. Birnbaum had her first child when she was 26, but says she feels more energetic now compared to she did back then.

"I am definitely more energetic," she told "20/20's" Elizabeth Vargas. "We have to redefine age, 'cause it's changed."

Although Birnbaum may be an outlier, it's clear that the average age of motherhood is on the rise. According to the Centers for Disease Control,as more women focus on their professions in their 20s and 30s, they are progressively putting off motherhood, and the overall U.S. birth rate has declined. But women in their early 40s are bucking the trend, seeing the highest birth rates for their age group since 1967.

Birnbaum and her husband, Ken, first became parents 35 years ago, when she gave birth to their son Jaeson. Four years later, she had her second child, Alana.

After their kids grew up, the Birnbaums became empty-nesters -- and they didn't like it.

"I had this biological urge that couldn't be stopped. When I saw a baby, I just wanted to take that baby away and run. You know, hold it and hug it," Frieda Birnbaum said. "As you get older, I've found I have more of an urge to have children than when I was younger."

Birnbaum says she became pregnant naturally in her forties but miscarried. Then she began in vitro fertilization treatments; she will not reveal whether she used her own eggs or donor eggs. At 53, she delivered her third child, Ari.

"It was just such a wonderful experience. I said, "You know what? I mean, we could do it again," said Ken Birnbaum.

The Birnbaums decided to pursue IVF again when Frieda was in her late 50s, but there was a hitch. Doctors in the United States refused to perform the procedure because of her age.

And they weren't the only ones voicing disapproval.

"Jaeson was angry at me," Frieda said of her oldest son, who is now in his 30s and has two children of his own. "(He) said we were crazy."

Birnbaum was able to get pregnant with the twins at age 59, with the help of a clinic in South Africa, where she said doctors seemed less concerned about her age. When pressed, Birnbaum admits she "may have" told doctors that she was younger than she was.

Some are concerned with more than just the standard risks facing older pregnant women -- hypertension, pre-term delivery, vaginal bleeding, preeclampsia, and gestational diabetes.

Dr. Arthur Caplan is a bioethicist at the University of Pennsylvania who strongly disagrees with Birnbaum's decision to give birth so late in life. He says it's just not the case that 70 is the new 50. Statistics show that even healthy people will begin to suffer mental and physical decline around the age of 70.

"The central question is what can we do to ensure the best interests of the children. And if you're going to be entering a nursing home when your child is entering junior high school, I think that's trouble," Dr. Caplan said.

Ari Birnbaum says that even today, he feels like his parents don't have enough energy for himself and his younger brothers.

"They seem to get very tired easily," he said.

These days the Birnbaums seem determined to prove the old adage "children keep you young," chasing after their three boys and socializing with parents half their age.

"I'm so inspired by life I am so excited by life," Frieda Birnbaum said. "I am more excited by life now than ever before."

Tiny Batteries Causing Big Health Problems for Kids

The little coin-sized batteries found in many toys, electronics and singing greeting cards could be life-threatening in children.

An research launched today by the Centers for Disease Control and Prevention and the Consumer Product Safety Commission found 14 children who are aged 13 and under have died, and more than 40,000 have been injured from small batteries.

Scott Wolfson, director of communications for the CPSC, called these batteries a “serious hazard.”

“There is growing attention to this hazard and an increase in the number of fatalities,” Wolfson said. “Today, more of these small batteries are being used in products such as remote controls, greeting cards, flashlights and CPSC is seeing children getting access to those batteries.”

Statistics in the report appear to support Wolfson’s argument that these cases are on the rise.

Of the 14 deaths reported between 1997-2010 half were reported in 2009-2010 and 72 percent of ED visits throughout 1995-2010 were among children aged 4 and under.

Part of what makes these ingestion so risky is by the time symptoms are like severe abdominal pain or vomiting, appear burns, ulcers and severe damage to the esophagus or gut has likely already occurred.

Director of pediatric emergency medicine at the University of Chicago, Alison Tothy, said, “That’s what’s so scary about these, you can get damage so quickly,”. “But how many parents bring their kids to the emergency department for a little stomach pain, but 8, 12, 14 hours later they are still having stomach pain and starting to vomit…and there is even more damage that has been done because battery has sat there for 24 hours.”

She said it’s important to bring children in right away if you think they swallowed something.

“The window of opportunity to get those out before they cause damage is pretty small,” she said. “It’s usually within four hours a battery can cause damage.”


Gary Smith, director of the Center for Injury Research and Policy at Nationwide Children’s Hospital and author of the May study, said,“We live in a world designed by adults for the convenience of adults, and the safety of children is often not considered,” .

Smith found ED visits doubled from 2,591 visits in 1990 to 5,525 in 2009 and the number of button batteries swallowed by children also doubled.

Chairman for the CPSC, Inez Moore Tenenbaum, has called on major manufacturers of button and coin-cell batteries to discuss about the safety of their products and wants to see safety standards in place to address the problem.


“We want these products that use button cells to be designed in a way that children can never get access to them,” Wolfson said. “We believe that there can be innovations in both the way the battery is made and how it is used in various products.”

Sen. Jay Rockefeller IV, D-W.Va., introduced a bill last year, would require all products with button batteries to be childproof.

The CPSC said parents should never let kids play with batteries and take caution to make sure they are disposed of properly.

If you think your child swallowed a battery call the national batteries ingest hotline: 202-625-3333 or the national universal poison control hotline: 1800-222-1222.