FDA Approves Testosterone for Underarms

The FDA last week approved a testosterone replacement solution for men that is applied to armpits using a deodorant-like applicator, a major milestone for the Australian company that developed the solution (partly owned by Eli Lilly) and a questionable breakthrough for men using the drug to correct a deficiency of the male sex-hormone, which causes low-libido among other problems.

Current testosterone therapies are delivered in a variety of ways including topical gels applied by the hands. The big advantage of armpit application is that it's less likely to rub off on others in the household--partners, children, pets--which can cause serious side effects, for example, aggressive behavior and premature development in children.Middle-aged men aspiring to The Situation's abs are trying testosterone replacement therapy. One downside to the new applicators is that the underarm area has many glands, which would absorb the testosterone with uncertain consequences.

Testosterone therapy is currently approved for use only in men with hypogonadism, whose sex glands produce extremely low amounts of testosterone or none at all because of an underlying disorder. But there's been an explosion of off-label use for age-related symptoms of testosterone decline including erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depression and loss of muscle. We are talking about male menopause--dudes with boobs and no libido--who can blame them for seeking a fix?

There are unanswered questions about the use of testosterone as an anti-aging drug for men. Use of the hormone has been shown to speed the growth of existing hormone-related cancers such as prostate tumors. Earlier this year, a federally funded study of testosterone gel--aiming to increase muscle in elderly, frail men--was halted due to a disproportionate number of heart attacks and other serious cardiac problems in the men on testosterone.

Still, some researchers are forging ahead with more research aimed to explore testosterone's anti-aging powers. Dr. Peter J. Snyder of the University of Pennsylvania School of Medicine is leading a much larger $45 million study financed by the National Institute on Aging. In the 12-center trial, 800 men 65 and older who have low testosterone will be randomly assigned to testosterone treatment or placebo for a year. The trial, which is actually a set of studies, will assess testosterone's effect on physical functioning, fatigue and sexual and cognitive function. ''There is even a cardiovascular trial, the hypothesis of which is that testosterone actually makes cardiac risk factors better,'' Dr. Snyder told the New York Times.

One of the major concerns over testosterone replacement as an anti-aging therapy is that it will be used by men who do not have low testosterone. In addition to serious concerns over the effect on cancer growth and heart disease, use of the hormone by men who do not have low testosterone can cause a host of problems, including shriveled testicles and lowered sperm count....not exactly the turn-on guys are looking for. 

Daily Pill Greatly Lowers Aids Risk

From The New York Times

Healthy gay men who took an anti-AIDS pill every day were well protected against contracting H.I.V. in a study suggesting that a new weapon against the epidemic has emerged.

In the study, published Tuesday by the New England Journal of Medicine, researchers found that the men taking Truvada, a common combination of two antiretroviral drugs, were 44 percent less likely to get infected with the virus that causes AIDS than an equal number taking a placebo.

But when only the men whose blood tests showed that they had taken their pill faithfully every day were considered, the pill was more than 90 percent effective, said Dr. Anthony S. Fauci, head of the infectious diseases division of the National Institutes of Health, which paid for the study along with the Bill and Melinda Gates Foundation.

“That’s huge,” Dr. Fauci said. “That says it all for me.”

The large study, nicknamed iPrEx, included nearly 2,500 men and was coordinated by the Gladstone Institutes of the University of California, San Francisco.

Research: Gene Links To Anorexia

Scientists at The Children's Hospital of Philadelphia have identified both common and rare gene variants associated with the eating disorder anorexia nervosa. In the largest genetic study of this psychiatric disorder, the researchers found intriguing clues to genes they are subjecting to further investigation, including genes active in neuronal signaling and in shaping interconnections among brain cells.

Anorexia nervosa (AN) affects an estimated 9 in 1000 women in the United States. Patients have food refusal, weight loss, an irrational fear of weight gain even when emaciated, and distorted self-image of body weight and shape. Women are affected 10 times more frequently than men; the disorder nearly always begins during adolescence. AN has the highest mortality rate of all psychiatric disorders, and successful treatment is challenging.

Twin studies and other family studies have suggested that AN is strongly heritable. "However, despite various genetic studies that identified a handful of candidate genes associated with AN, the genetic architecture underlying susceptibility to AN has been largely unknown," said study leader Hakon Hakonarson, M.D., Ph.D., director of the Center for Applied Genomics at The Children's Hospital ofPhiladelphia. The research appeared online in Molecular Psychiatry on Nov. 16.

"This is the first genome-wide association study on a large anorexia cohort, as well as the first study of copy number variations in the disorder," said Hakonarson. Genome-wide association studies (GWAS) search for single-nucleotide polymorphisms, or SNPs—common gene variants that typically act as pointers to a gene region with a small effect on raising disease risk. The study team also performed a parallel search for copy number variations (CNVs), rarer variants that usually have a stronger impact on disease risk.

"We confirmed results of previous studies of anorexia nervosa: SNPs in the gene OPRD1 and near the gene HTR1D confer risk for the disease," said Hakonarson. "We did not detect other obvious candidate genes, but we did generate a list of other genes that we are analyzing in follow-up studies." One SNP is between the CHD10 and CHD9 genes, a region that Hakonarson associated with autism spectrum disorders in 2009. Called cadherin genes, CHD10 and CHD9 code for neuronal cell-adhesion molecules—proteins that influence how neurons communicate with each other in the brain.

The current anorexia study also investigated CNVs—deletions or duplications of DNA sequences. Previous research by Hakonarson and others has shown that CNVs play a significant role in other neuropsychiatric disorders, such as schizophrenia, bipolar disorder and autism.  

The current study suggests that CNVs may play a less important role in anorexia than they do in schizophrenia and autism. Nonetheless, the researchers identified several rare CNVs that occurred only in AN cases, including a deletion of DNA on a region of chromosome 13.

Preliminary Trial: Stem Cell Patch Heals a Broken Heart

When a person has a heart attack the heart muscle is damaged and scarred, cells die off and the heart's ability to pump blood is reduced. Until now there hasn't been much anyone can do about that beyond containing the damage and hoping the heart can limp along and continue to do its business with perhaps less vigor. So one can only imagine the intense interest at the annual American Heart Association convention today when researchers from the University of Cincinnati presented the results of an ingenious experiment conducted using a stem-cell infused patch to help repair damage to the heart.

The researchers fashioned the patch with cardiac progenitor cells (stem cells that differentiate into heart muscle cells as they grow) and a couple of other heart-tissue-promoting substances only molecular biologists can fathom. They placed it on (PETA members avert eyes now) lab animals hearts' three days after a heart-attack. One month after the cell patch implantation, echocardiograms were performed to evaluate heart function.

What they found was quite remarkable: The number of heart tissue cells and heart function as a whole significantly increased in animals that received the patch. "Hopefully, one day such treatments will restore cardiac function in patients who have experienced a heart attack, leading to a longer and better quality of life," said lead researcher, Yi-Gang Wang, PhD.

This leads to our latest maxim: Where there's good science, there's always hope for better health.

A Gene that Magnifies the Pain of Getting Bullied

A new study finds that bullied children who have inherited a gene sequence called the 5-HTT short alele--a stress-related gene that codes for seratonin transport and is associated with low seratonin levels in the brain--develop the most emotional problems from bullying. Symptoms of anxiety, depression and social withdrawal appeared most often in regularly bullied kids with two copies of a short version of the 5-HTT gene, says a team led by psychologist Karen Sugden of Duke University in Durham, NC. One-third of bullied children who had two short copies of the gene displayed emotional problems severe enough to merit mental health treatment. In another study, Stanford University researchers found that teenage girls who were socially excluded or lied about by peers showed more signs of depression if they had two copies of the short 5-HTT gene. 

This is not the first time researchers have found traits of concern in connection with this particular sequence of short aleles. (An alele is a form of the DNA sequence of a particular gene that sets a genetic trait like eye color, hair color and even stress coping styles: researchers commonly divide the gene sequence into two variations, short and long, but there can be multiple variations.) Previous research links greater risk of depression after stressful events, alcoholism, obesity, methamphetine addiction and even suicide to one or two short aleles in the 5-HTT region of the seratonin transport gene known as SLC6A4. (Could scientists be required to take poetry so they can better name stuff?)

An underlying genetic vulnerability to stress makes sense in light of recent events in which we've seen some young people crack more easily from cyber-bullying than others. And it gives counselors ample justification to intervene early when signs of sensitivity to bullying emerge. The short alele genetic trait's association with lower seratonin levels in the brain provides a therapeutic target. For example, the supplement SAMe provides more of the raw material for making seratonin, and can increase seratonin levels in the brain. Regular exercise has also been shown to up seratonin levels, and other studies have identified the alkaloids in chocolate as seratonin boosters.  

Read the Science News article.