Truvada: 5 Things to Know About the First Drug to Prevent HIV

Doctors now have another weapon against HIV/AIDS in their arsenal, and it’s a potent one. For the first time, the U.S. Food and Drug Administration (FDA) approved a drug treatment that will prevent infection in healthy people.

The drug, called Truvada, which is already approved for the treatment of HIV in infected patients, works by lowering the amount of virus circulating in people’s blood. But clinical trials show that it can also protect uninfected high-risk people from acquiring the virus, if they take the drug daily before and after exposure.

The approval is controversial. Some public health experts argue that allowing the drug to be used for prevention will foster a false sense of security among users, leading people to believe mistakenly that they are immune to the virus and reduce their use of condoms. However, the FDA determined that the benefits of expanding the pool of people who may use Truvada to protect against HIV made it worth approving. Here’s what you need to know.

Who can take Truvada?

The drug, made by Gilead Sciences Inc., is approved for healthy, uninfected people who are at high risk of contracting HIV through sex. These include sex workers and people with partners who are HIV-positive or engage in high-risk behaviors, such as using IV drugs.

How effective is the drug in preventing HIV?

In one study, healthy gay and bisexual men who took Truvada daily and were counseled about safe sex practices lowered their risk of becoming infected by up to 42%. In another study involving heterosexual couples in which one partner was HIV-positive, the uninfected partner had a 75% lower risk of contracting HIV if they took Truvada.

Does Truvada cure AIDS?

No. The drug can treat people who are infected with HIV by lowering the amount of virus in their bodies and slowing down the progression of the disease. In healthy, uninfected people, the drug can thwart HIV’s ability to take hold in healthy cells and start an infection, by blocking the activity of an enzyme that the virus needs to replicate.

Why is the approval controversial?

Some experts believe that healthy people may not take the drug correctly — it needs to be taken daily to be effective — which would encourage HIV to become resistant to the medication. Public health officials also worry that people may engage in more risky behaviors when they are on the drug, believing they are protected completely against HIV, which they are not. However, patients who receive Truvada prophylactically will be expected to participate in a comprehensive HIV protection plan involving regular HIV testing, condom use and prevention counseling and support. Clinical trials have not shown that users are more likely to engage in risky sexual behavior.

Researchers also can’t explain why in one study involving female sex workers, those who took Truvada to prevent HIV were not protected against infection. The authors think that the participants did not take the drug in the right doses, but it’s also possible that something about the vaginal environment makes the drug less effective.

Why is the approval important?

Approving a drug to prevent HIV marks a big step toward controlling the spread of HIV and AIDS, not just in the U.S. but worldwide as well. Once Truvada is used as a preventive measure domestically, U.S.-backed AIDS programs in the developing world may also begin to roll out the pill for healthy people who are at high risk of contracting HIV. Public health experts are eager to build up all effective prevention strategies, noting that the only way to stop the epidemic is by preventing new infections as well as treating existing ones.

healthland.time.com

Study: HIV Rates in Gay Black Men Are Alarmingly High

A study of black gay and bisexual men in six U.S. cities finds that rates of HIV are increasing at a troublesome pace: each year, nearly 3% of gay black men become infected with HIV, a 50% higher rate than among their white counterparts.

The new-infection rate in gay black men under 30 is even higher, at 6% a year, according to the new data presented Monday at the annual International AIDS Conference in Washington, D.C. These numbers are comparable to HIV rates seen in sub-Saharan Africa, in countries that are hardest hit by HIV, the authors of the study note.

“This is extremely concerning,” Kenneth Mayer, medical research director at Fenway Health, a leading HIV/AIDS clinic in Boston, and co-chair of the study, told USA Today. “Here we are, this far into the epidemic, and we have these rates.”

The new numbers come from the HIV Prevention Trials Network (HPTN), a study funded by the National Institutes of Health. The study, conducted between 2009 and 2011, involved 1,553 gay and bisexual men from Atlanta, Boston, New York, Los Angeles, San Francisco and Washington, D.C.

The majority of the men in the study identified themselves as black. Not all the men identified themselves as gay or bisexual, but all the participants were having unprotected sex with men. More than 97% of men enrolled were willing to have an HIV test, and the results suggest that many men are not fully aware of their HIV risk: among those who thought they were HIV-negative or didn’t know their status, 12% tested positive.

“The…study findings are a sobering wake-up call,” said study author Dr. Wafaa El-Sadr in a statement.

Last week, another new study [PDF] by the Black AIDS Institute also highlighted the alarming rate of infection among black men who have sex with men (MSM). While only 1 in 500 Americans is a black gay or bisexual male, they account for 1 in 4 new HIV infections in the United States, the report found. It also found that a black gay man has a 1 in 4 chance of becoming infected by age 25; by age 40, he has a 60% of becoming HIV positive.

The Centers for Disease Control and Prevention (CDC) notes that from 2006 to 2009, HIV infections among black gay and bisexual men under 30 increased 48% and that African Americans are overall disproportionately affected by HIV. Blacks make up 14% of the U.S. population, but account for 44% of all new HIV infections. According to 2009 data, 73% of new infections in black men are in gay and bisexual men

“We have known that black MSM are affected by HIV at disproportionately higher rates when compared to other MSM in the U.S., but the [new study's] HIV incidence rates were extremely high,” said study co-chair Dr. Darrell Wheeler, dean of the school of social work at Loyola University, in the statement. “They make it very clear that we must urgently find and implement ways to stem the spread of HIV among black gay men in this country, and critically among young black gay men.”

(MORE: How the Global War on Drugs Drives HIV and AIDS)

The study found further that HIV risk among this population was associated with income and health overall. Those who tested positive for HIV were more likely to have another sexually transmitted disease (STD) and to be poor. USA Today reported:

Both increase the risk of disease transmission. STDs create inflammation that make it easier for the AIDS virus to enter the body. And because poor people generally have more problems getting health care, they’re less likely to be tested, know their status and be on treatment, Mayer says. Recent studies show that effective treatment can make patients virtually non-contagious, and most AIDS researchers at the conference this week now seem to see “treatment as prevention” as the best hope for containing the disease.

The study reinforces the notion that fighting AIDS will involve more than just changing individual behavior, Mayer says. Research has consistently linked HIV infections with poverty, suggesting that the country needs to address “structural” issues, such as homelessness, discrimination and economic opportunity, Mayer says.

More than a million Americans are currently living with HIV, a high HIV rate that makes prevention efforts more difficult. As Mayer pointed out, prevention becomes even more problematic among the small population of gay black men who tend to date other men within their racial group and face even higher risks of being exposed to HIV.

Recent data show that the disparities between black and white gay men don’t come down to risky behavior. Blacks and whites tend to have similar numbers of sexual partners and are equally likely to to have risky sex. CDC data also suggest that the higher rate in black gay men isn’t attributable to jail time or circumcision rates.

Further analysis of data from the HPTN study will focus on how behavioral and societal factors affect HIV risk in gay black men, including incarceration, childhood experience, social and sexual networks, discrimination and homophobia, and access to health care.

healthland.time.com/

Lack of Exercise as Deadly as Smoking, Study Finds

When it comes to being couch potatoes, Americans aren’t alone. Physical inactivity has become a global pandemic, say researchers in a series of related papers  published in the journal Lancet. According to one of the reports, lack of exercise causes as many as 1 in 10 premature deaths around the world each year — roughly as many as smoking.

About 5.3 million of the 57 million deaths worldwide in 2008 could be attributed to inactivity, the new report estimates, largely due to four major diseases: heart disease, Type 2 diabetes, breast cancer and colon cancer. The study finds that if physical inactivity could be reduced by just 10%, it could avert some 533,000 deaths a year; if reduced by 25%, 1.3 million deaths could be prevented. Say we got everyone off the couch and eliminated inactivity altogether: the life expectancy of the world’s population would rise by about 0.68 years (more, if you discount those who were already active), comparable to the effect of doing away with smoking or obesity.

For the study, led by I-Min Lee in the division of preventive medicine at Brigham and Women’s Hospital, scientists calculated something called a population attributable fraction (PAF), a measure of the contribution of risk factors like physical inactivity to diseases such as heart disease or diabetes, and even risk of death. The PAF told researchers how many cases of disease could theoretically be prevented if the risk factor were eliminated — that is, if all inactive people in a population were to start exercising sufficiently.

Lee and his colleagues collected data on physical inactivity and outcomes of the four major diseases — heart disease, Type 2 diabetes, breast cancer and colon cancer — as well as rates for death from all causes. They then calculated PAFs for 123 countries. Overall, the estimates suggest that lack of exercise causes about 6% of heart disease, 7% of Type 2 diabetes, and 10% of breast and colon cancers worldwide.

Exercise has long been known to can lower risk factors like high blood pressure, high blood sugar and high cholesterol, which in turn reduces the risk of heart disease and diabetes. Physical activity also keeps heart vessels healthy and inhibits the formation of atherosclerotic plaques that can cause blood clots.

As for breast cancer, exercise may protect women by reducing fat — particularly dangerous belly fat, whose metabolic activity may trigger tumor growth in breast tissue. Colon cancer may work differently: researchers believe that exercise helps keep digestion regular and prevents potentially cancer-causing waste from encouraging abnormal growths in the colon.

Current guidelines recommend that people get about 150 minutes of moderate exercise a week — a half-hour of brisk walking five times a week would do it. But in another Lancet paper published in the series, Pedro Hallal of the Federal University of Pelotas, in Brazil, and his colleagues found that 31% of adults worldwide (1.5 billion people) and 4 out of 5 teens aren’t exercising enough to meet that standard and therefore putting themselves at risk for chronic disease.

The researchers analyzed self-reports of exercise among adults in 122 countries, representing 89% of the world’s population, and among teens in 105 countries. Rates of physical inactivity were higher in high-income countries than in low-income nations. The Americas were overall the most sedentary region — with 43% of the population not exercising enough — while rates of inactivity were lowest in southeast Asia (17%).

One key reason is that we rely too much on modern conveniences like cars to get around. In the U.S., for example, fewer than 4% of people walk to work and fewer than 2% bike to commute; compare that to about 20% of people who walk to work in China, Germany and Sweden, and the more than 20% who bike their commutes in China, Denmark and the Netherlands, WebMD reports. Add to that the inordinate time most of us spend sitting — at the office, in front of the computer or watching TV.

Hallal estimates that sedentary people have a 20% to 30% greater risk of heart disease and diabetes than regular exercisers. But despite the deadly effects of lack of exercise, Hallal says physical activity doesn’t get the same attention or funding as other health risk factors. “It gets underfunded and undervalued,” Hallal told the Los Angeles Times. “But it’s huge everywhere in the world.”

There was some encouraging news in the results as well: thanks to greater awareness about the importance of physical activity in improving health, about 31% of adults do report engaging in vigorous exercise three or more days a week.

Another paper in the Lancet series also examined what kinds of interventions might help people get active. Researchers analyzed 100 reviews of clinical and community-based efforts to encourage exercise and found some simple strategies that seemed to work: using signs to motivate people to use the stairs instead of the elevator, for instance, or offering free exercise classes in public places such as parks, especially geared toward women, lower-income folks and the elderly, groups who are less likely to get the recommended amount of exercise. Studies from the U.S., Australia, Belgium, Canada, England and Germany indicate that maintaining streets and improving lighting can boost activity levels by as much as 50%.

The authors of the study pointed to a particularly effective program called Ciclovía, which started in Bogotá, Columbia, and has spread to 100 other cities in the Americas. On Sunday mornings and public holidays, the program closes city streets to motorized vehicles, leaving roadways open for walkers, runners, skaters and bikers. Ciclovía attracts about a million people each week, the study notes, mostly people on lower incomes, and accounts for 14% of people’s weekly recommended exercise.

Commenting on the Lancet series, many experts agreed that physical activity should be a global priority, though some took issue with the comparison with smoking. In an interview with WebMD, Timothy Armstrong, coordinator of the surveillance and population-based prevention program for the World Health Organization, noted that if the authors of the first paper had calculated the effects of smoking the same way they had for inactivity, the death statistics wouldn’t be quite so similar. Further, as Dr. Claire Knight of Cancer Research U.K. told the BBC, even if smoking and inactivity kill the same number of people, far fewer people smoke than are sedentary, making tobacco more risky to the individual.

Nevertheless, no one disagrees that the world population as a whole must start exercising more — and soon. “This is a super, super analysis,” Dr. James Levine, professor of medicine at the Mayo Clinic, told WebMD regarding Lee’s paper in the Lancet. “We know that as soon as somebody gets out of their chair, their blood sugar improves, their blood cholesterol and triglycerides improve, and that’s very consistent. Every time you get up it gets better. Every time you sit down it gets worse.”

The message, he says, is simple — get moving.

AGD And Male Fertility

Men’s obsession with size in their nether region may be justified after all. New research indicates size — of a sort — does matter when it comes to male fertility.

It turns out it’s not penis size that’s significant, but the length as measured from the anus to underneath the scrotum, known as anogenital distance, or AGD, according to research published this month in the journal Environmental Health Perspectives. (More on Time.com: Is Coverage of Infertility Treatment an Essential Benefit?)

Fertility testing is nothing if not invasive, but the research, from the University of Rochester Medical Center, means that the latest tool in the fertility arsenal might soon be a lowly tape measure.

AGD is associated with semen volume and sperm count, according to study author Shanna Swan, a reproductive epidemiologist and professor in obstetrics and gynecology at the University of Rochester.

The median AGD length is about 2 inches; men with a shorter measurement stand a seven-times greater risk of having fertility problems as opposed to men with a longer AGD. They are more likely to be sub-fertile, which generally indicates a sperm count of less than 20 million per milliliter. Men with sperm counts in this range are only half as likely to succeed in getting a partner pregnant as men with more typical sperm counts in the range of 50 to 60 million sperm per milliliter. (More on Time.com: Sperm on Steroids: 6 Inches Long and Raring to Fertilize)

The researchers, who measured the AGDs of 126 college students who were not attempting to get a partner pregnant, did not attempt to analyze why some men had shorter AGDs than others. But earlier research has raised the possibility that pregnant women exposed to a controversial class of chemicals called phthalates — used in perfumes and personal care products including shampoos, as well as PVC-infused products such as shower curtains and floor coverings — may give birth to boys with shorter AGDs.

In 2005 and again in 2008, Swan found that mothers exposed to high levels of phthalates during pregnancy bore baby boys with reduced AGD and penis size. In previous animal studies, shorter-than-average AGD in male rodents has corresponded with eventual fertility problems.

“We’re not at all saying chemicals are the only explanation, but we found when women are exposed to common phthalates that decrease testosterone, there is a whole cascade of things that can happen,” says Swan. “The short AGD is not happening in isolation.”

Not everyone is quick to embrace the linkage. “Assessment of AGD as a routine evaluation of one’s fertility is premature,” Natan Bar-Chama, who heads the male reproductive medicine at Mt. Sinai Hospital in New York City, told Reuters. (More on Time.com: Stress Doesn’t Hurt Chances of Success with IVF)

Swan acknowledges that her study needs to be replicated, but she believes her current research, along with previous data from animals and humans, suggests AGD is a “reliable marker” of potential infertility.

When combined with sperm count analysis, AGD is not a diagnosis in and of itself, but it can be useful test in terms of providing additional information to doctors and couples.

It’s also easy to administer. No pokes and prods needed; just a simple measurement that’s so easy, couples having trouble getting pregnant could conceivably do it at home.

Which may or may not be a good idea. “I’m not going to recommend that people do it yet,” says Swan, “but I suspect it’s happening.”

healthland.time.com

Much More May Be Written in the Length of His Fingers

The ratio of the length of a man’s index finger to that of his ring finger may seem like a strange thing to measure, but new research suggests that it’s linked with penis size. The lower the ratio, the longer the penis.

The new study was conducted on 144 Korean men who were hospitalized for urological surgery. A researcher measured the patients’ penile length — flaccid and stretched — just after they went under anesthesia for their operations. A different researcher measured the men’s finger lengths, in order to prevent knowledge of one measurement unconsciously affecting the other.

They data suggested that those with a lower ratio, whose index finger (or second finger, 2D) was shorter than the ring finger (or fourth finger, 4D), had a longer stretched penis length, which is well correlated with erect size.

“Based on this evidence, we suggest that digit ratio can predict adult penile size,” the researchers, led by Dr. Tae Beom Kim of Gachon University in Incheon, Korea, wrote.

Previous studies have linked the so-called 2D:4D ratio of finger length with exposure to the sex hormones estrogen and testosterone in the womb. So it’s plausible that the same exposure may affect penis length.

Higher testosterone levels during fetal development are associated with a lower 2D:4D ratio, while higher estrogen levels are connected with a higher one. Most men have index fingers that are shorter (low ratio) than their ring fingers, while most women’s index fingers are the same size or longer (high ratio) than their ring fingers.

Finger-length ratios have been linked previously with a variety of other characteristics: in both males and females, lower ratios are associated with better athletic performance. In men, one study found that a lower ratio was connected with more success at high-frequency financial trading, while another study associated it with better performance on medical school entrance exams; women were not included in those studies.

Men with lower 2D:4D ratios were also more likely to have more “masculine” features, to have more symmetrical faces, and to be considered attractive by women, according to another study.

Yet other research links low 2D:4D ratios with higher rates of alcohol consumption and alcoholism itself. Some data suggest that a more “female” finger-length ratio in men is associated with increased risk for oral cancer but reduced risk for prostate cancer.

In both boys and girls, lower and more “male” 2D:4D ratios have also been repeatedly connected with autism; interestingly, a recent study also found that female-to-male transgendered people are more likely to have autistic traits.

Of course, it remains to be seen whether the correlation between penis size and 2D:4D ratio holds true in non-Korean men or in Korean men who aren’t having some type of urological surgery.

But if so, digit ratio could be good for more than just a pick-up line at a bar. An easy and non-invasive measurement, it could give doctors a quick way to gauge how much testosterone their patients were exposed to in the womb, wrote Dr. Denise Brooks McQuade of Skidmore College in Saratoga Springs, N.Y., in an editorial accompanying the study.

The study was published in the Asian Journal of Andrology.

TIMEHealthland.com

Bangladesh is the largest nation to never win a medal, but it has four athletes in London

• Pavel Rahman - Young Bangladeshi children hold the national flags as they pay tribute to martyrs of the …more liberation war at the National Memorial during the Independence Day celebrations at Saver on the outskirts of Dhaka, Bangladesh, Monday, March 26, 2012. Bangladesh celebrates its 41st independence day Monday. (AP Photo/Pavel Rahman) less

LONDON – Bangladesh is home to more than 152 million people, making it the eighth most populated country in the world, yet its Olympic futility is so bad it makes one wonder if a statistical mistake has been made.

Bangladesh, sandwiched between northeastern Indian and Myanmar, has never won a single medal at the Olympic Games and is unlikely to do anything to change that tortured record over the next few weeks.
But it is not even the total lack of hardware that is the most telling sign of failure for this nation whose primary national sporting obsession, cricket, is not in the Games. Not that it would likely do much for the medal count anyway – it is ranked ninth out of the nine teams that play at cricket's highest level.

Of the International Olympic Committee's 204 members, 80 have never medaled. Many of the nations are tiny by comparison, although Myanmar (the world's 25th most populated country) and Nepal (45th) are also on the medal-free list.
Meanwhile, Tonga (195th in population) has an Olympic silver, Barbados (181st) a bronze and Iceland (178th) two of each. The Bahamas, ranked 177th, has excelled with 10 total medals, four of them gold.
Perhaps most extraordinary about Bangladesh is not its dearth of medals, but that it has never had an athlete qualify for an Olympics based on performance in competition.
Every one of the country's representatives, stretching back to 1984, has been courtesy of the IOC's wildcard system, devised to assist competitors from nations low on the international sports pecking order.
That is the case again for London, where a four-strong Bangladesh team featuring an archer, a gymnast, a shooter and a swimmer will march in the Opening Ceremony, all of them thanks to the wildcard allotment.

The gymnast is Syque Caesar, an American born in Florida to Bangladesh parents and with dual citizenship. Caesar may be the most accomplished athlete Bangladesh has ever brought to a Games, having won an NCAA teams title at the University of Michigan and won parallel bars gold at the Central South Asian Championships.
Caesar's participation was only made possible through bizarre circumstances: The Indian federation failed to correctly file the paperwork for its gymnast Ashish Kumar on time, and Caesar was next in line to accept the wildcard position.
It will be a significant moment of pride for the 21-year-old, whose Wolverine colleague and roommate Sam Mikulak will represent the U.S.
"Bangladesh loves sports," Caesar told the BBC. "My father used to play for the national soccer team, and soccer was the country's main passion. That died down and now the country loves cricket.
"Gymnastics isn't really such a popular sport around the globe anyway, but hopefully I'll be the guy that kick-starts a program in the country."
Bangladesh's Olympic woes are viewed as serious by the government, so much so that the topic has been raised in the national parliament. Extra funding has been allocated to develop talent in a range of sports, although progress will be a gradual, long-term process.
"Bangladesh is willing to do everything to get as many athletes as it can to the Olympics," Caesar said. "But having the resources to prepare athletes for the Games is quite new for them."
-ESPN.

FDA Approves Drug to Prevent HIV Infection

July 16, 2012 — The US Food and Drug Administration (FDA) today approved tenofovir disoproxil fumarate/emtricitabine (Truvada, Gilead) to reduce the risk for HIV infection in uninfected individuals at high risk of catching the virus, possibly through sexual activity, the agency announced.

The antiretroviral agent is now the first drug approved for prophylactic use. It is currently indicated — in combination with other antiretrovirals — to treat HIV-infected adults and children aged 12 years and older.

Patients prescribed tenofovir disoproxil fumarate/emtricitabine for preexposure prophylaxis (PrEP) are to take the drug daily as part of a comprehensive HIV prevention strategy, which includes safe sex practices, risk reduction counseling, and regular HIV testing.

The FDA is adding a boxed warning to the drug to warn that it should be prescribed for PrEP purposes only for individuals who are confirmed as HIV-negative both before taking the drug and at least every 3 months afterward. The antiretroviral is contraindicated for individuals with positive or unknown HIV status.

The agency predicated its approval of tenofovir disoproxil fumarate/emtricitabine for PrEP on a risk evaluation and mitigation strategy (REMS) for proper use of the drug. It consists mostly of a training program for prescribers to help them counsel patients on several key points:

•               The drug should not become a substitute for a condom, but rather, an adjunct to condom use and other preventive measures.

•               The antiretroviral must be taken daily, because its effectiveness strongly correlates to adherence. In addition, intermittent use — as a "party drug," for example — might spur on the development of Truvada-resistant HIV.

•               Monitoring a patient's HIV status after the start of PrEP is crucial because if a patient subsequently becomes infected, he or she should switch from the stand-alone antiretroviral to the combination of antiretrovirals for treating — as opposed to preventing — HIV infection. Also, an HIV-positive patient who continues to take Truvada by itself risks the development of a drug-resistant virus.

In May, the FDA's Antiviral Drugs Advisory Committee strongly backed the approval of tenofovir disoproxil fumarate/emtricitabine for PrEP, but recommended a more rigorous REMS than originally proposed by the manufacturer. Committee members, for example, wanted a requirement that a patient test negative for HIV before receiving each 30-day supply of the antiretroviral. The final REMS approved by the agency did not include this provision.

Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research, said in a press briefing today that the antiretroviral for PreP will help the nation reach a federal goal of reducing the number of newly diagnosed HIV infections each year by 25% by 2015. Dr. Birnkrant said that the number of new infections per year among adults and adolescents has plateaued at 50,000.

No New Adverse Events Identified

Two clinical trials established the safety and effectiveness of tenofovir disoproxil fumarate/emtricitabine for PrEP. One trial called the Preexposure Prophylaxis Initiative (iPrEx) found that the antiretroviral reduced the risk of HIV infection by 42% among men who have sex with men (MSM) compared with the use of a placebo, according to the FDA. All participants received monthly HIV testing, free condoms, treatment of other sexually transmitted infections, and routine counseling.

The other trial, called Partners PreP, compared the use of tenofovir disoproxil fumarate/emtricitabine, tenofovir disoproxil fumarate by itself, and a placebo among 4758 couples in Uganda and Kenya who were serodiscordant. The risk of the HIV-negative partner becoming infected decreased by 75% if he or she took tenofovir disoproxil fumarate/emtricitabine.

In the 2 studies, "condom use increased over time, and sexually transmitted infections either remained at baseline, or also decreased," Dr. Birnkrant said at today's press briefing.

The 2 PrEP clinical trials did not identify any new adverse events for tenofovir disoproxil fumarate/emtricitabine, according to the FDA. The most common ones included diarrhea, nausea, abdominal pain, headache, and weight loss.

The agency also revised the drug's label to warn of the possible onset or worsening of renal impairment, and decreases in bone density. However, these adverse events have been uncommon.

More information on today's decision is available on the FDA Website.

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10 risks for contact lens wearers

A small disc of thin plastic is fitted to your eyeball and, just like that, the world's fuzzy edges sharpen into focus! Contact lenses bring normal vision to the nearsighted and farsighted masses. So many of us wear contacts nowadays, and they've become so supremely easy to wear that we may get a little lax about taking care of them.

When we fail to properly wear, care for, and clean our contact lenses, our eyes become more vulnerable to infection. Contact lens wearers, take note of these 10 moments when you might be putting your eyes at unnecessary risk.

When you handle your lenses: Naturally, this step invites infection and irritation - you are putting your finger in your eye, after all. Thoroughly wash your hands before touching your contact lenses or your eyes, and trim your fingernails short so you don't tear or scratch your lenses. Never use tap water or saliva to wash your lenses - stick to the contact lens solution appropriate to your lens type. Ask your eye care professional which solution is right for you.

When you wear your lenses too long: There's a good reason why many eye doctors advise against the use of extended-wear contacts. Contact lenses block oxygen to your eyes. If you wear them overnight or for longer than prescribed by your eye care professional, you boost your risk of corneal ulcers that can scar your cornea or even cause blindness.

When you take medications: You would, of course, remove your lenses before putting in any type of eye-drop medication. But did you know that certain types of medications can have an impact on your contacts? Taking the birth control pill boosts estrogen and can make a woman's eyes more sensitive to her contacts, as well as decreasing tear output and making her eyes drier. Antihistamines to ease an allergy might also dry out your eyes. Certain types of acne medication can cause an itchy sensation, and plain old aspirin can irritate the eyes. Be sure to tell your eye care professional about any medications you take on a regular basis.

When your solution becomes the problem: Contact lens solutions come in many varieties: some rinse, some clean, some disinfect, some rewet the eyes or boost tear production, and some multipurpose formulas do it all. Each of these types of products contains preservatives that can expire or become irritating to the eyes. Don't use the solution if it's past its expiration date. Trouble can arise when switching brands or types of solutions. Even if you stick to the same brand, the manufacturers may alter the solution, so watch for labels that say things like "new and improved." Also, never transfer solution into a smaller container for travel or to carry in your purse - this can increase the risk for contamination.

When your eyes get too dry: Since contacts cover the surface of the eye and restrict oxygen, many wearers experience dry eyes now and then. And the dryness can become even worse in certain situations such as on an airplane, in a dry climate, while taking antihistamines, or after drinking alcohol. Carry a bottle of artificial tears or rewetting drops, and be sure to blink often to keep eyes lubricated.

When you put on makeup: Your makeup bag and vanity table is filled with possible eye irritants. Never share eye makeup or apply shadows, mascara, or eyeliner to swollen, red, or infected eyes. Choose water-resistant mascara instead of waterproof or lash-extending formulas. Opt for water-based hypoallergenic moisturizers, lotions, and foundations since creamy products can smudge and film up your lenses. And timing matters, too - if you wear soft contacts, insert your lenses before you apply makeup. Wearers of rigid gas-permeable lenses should wait until after. For both types of lenses, remove your contacts prior to removing makeup.

When you visit the hairdresser: Salons swarm with airborne chemicals from hairsprays and other products. Either don't wear your contacts to your next appointment or shield your eyes. Blink more frequently if you're stuck beneath a hair drier.

When you go outside: Tiny airborne irritants like dust, pollen, mould, smoke, and pet dander can make their way into your eyes and stick to your contacts can irritate your eyes. Excessive tearing in reaction to allergens can make it uncomfortable to wear your contacts. Consider switching to your glasses on high pollen days or when you know you'll encounter irritants.

When you take a dip: Sure, it's no fun to dive into the pool in your glasses. But wearing your contacts into a chlorinated pool or who-knows-what-infested natural body of water puts your lenses at risk of contamination. If you can manage it, swim lens-free and wait about an hour before you put your contacts back in.

When you light up: Smokers know that they put their health at risk whenever they stoke up a cigarette. But smokers who wear contacts are at 8 times the risk of developing corneal ulcers than non-smoking lens wearers.

Consult an eye care professional if you experience symptoms such as hazy or blurred vision or eye pain, or if you detect signs of an eye infection including discharge, itching, burning, or sensitivity to light. At the first sign of infection, remove your contact lenses.

Surgery Not The Best Idea For Prostate Cancer

     

Men with early stages of prostate cancer may be better off having their disease monitored rather than going through harsh treatments such as surgery, according to a recent study that found that men in their 60s who had the invasive surgery actually didn’t live significantly longer than those who were only monitored.
Results of the research, published Wednesday in the New England Journal of Medicine, suggests that men do not need immediate treatment, especially if their PSA scores are low or they have low-risk tumors that are unlikely to rapidly grow and spread.
Overall, most men in the clinical trial, performed at Massachusetts General Hospital and other facilities, did not benefit from surgery and did not reduce the likelihood they would die from prostate cancer or other causes.
However, the researchers did find that surgery did reduce mortality in two groups of men – those with relatively high PSA levels (greater than 10 ng/mL) and those with higher-risk, more aggressive tumors.
“What we found really suggests that treatment has a limited effect for most tumors and that PSA screening is finding many cancers that wouldn’t have otherwise caused problems,” said study coauthor Dr. Michael Barry, chief of general internal medicine at Massachusetts General Hospital.
The trial involved 731 men with an average age of 67 and who were diagnosed with early-stage prostate cancer detected by PSA screening, rectal exams and biopsies. Roughly half the patients were randomly selected to have their prostate removed through surgery and the rest received monitoring only.
PSA testing and bone scans were done on the monitor only group every six months for the duration of the study to search for signs of tumor spreading.
After 12 years, 47 percent of men who had the surgery died, compared to 49.9 percent of the men who were assigned observation only; the difference was not statistically significant. What was significant, however, was that more than one in five men who underwent surgery had adverse effects, although those with PSA scores greater than 10 did benefit from the operation.
About 17 percent of those having the surgery ended up getting urinary incontinence compared with 6 percent who did not have the operation. Furthermore, 81 percent in the surgery group had erectile dysfunction compared with 44 percent of those who were only monitored.
About 20 percent of those in the monitoring group eventually opted for treatment during the study because of personal choice or because their cancers appeared to be progressing during the biannual screenings.
Based on the study findings, lead author Dr. Timothy Wilt said: “observation is a wise and right decision for men with prostate cancer detected by PSA.” he noted that this study agreed with the recent recommendation by the US Preventive Services Task Force (USPSTF), which recommended in May that PSA screenings should not be used for testing prostate cancer in men.
About 66 percent of the 240,000 American men who are diagnosed with prostate cancer each year have tumors that pose little risk of spreading. Yet, nearly 90 percent of these men still have surgery or radiation, which may cause side effects such as impotence and incontinence. The troubling issue is that current tests aren’t able to accurately distinguish between aggressive cancers and non-threatening tumors.
An accompanying editorial to the study pointed out that the researchers’ failure to enroll 1,200 men as was originally planned may have made it impossible to detect modest but significant reduction in deaths in the group who had immediate surgery.
Some cancer experts said the study’s findings do not apply to younger men. A large percentage of those under 65 with early stage prostate cancer will most likely still opt for immediate treatment, according to Dr. Anthony D’Amico, chief of genitourinary radiation oncology at Brigham and Women’s Hospital.
“We can’t conclude from the study data that a healthy 50-year-old man with low-risk disease should skip treatment because the follow-up isn’t long enough to determine whether his disease will progress,” D’Amico said.
Most experts acknowledge that this study helps identify which patients do not require surgery for prostate cancer. However, most disagree with the idea that all prostate cancer detected with PSA should simply be observed.
“With early diagnosis and improvements in treatment during the past 20 years, the prostate cancer death rate has decreased by 44 percent in the U.S.,” Dr. William Catalona, medical director of the Urological Research Foundation, told ABC News.
“This trial should not provide men with another excuse not to get tested or treated for prostate cancer,” added Catalona, who developed PSA screening for prostate cancer.
“Rather than characterizing the study as showing no benefit from surgery compared to observation, this study provides evidence that surgery will reduce metastasis and death from prostate cancer particularly in men with intermediate or high risk tumors,” said Bruce Trock, professor and director of the Division of Epidemiology in the Brady Urological Institute.

Lawrence LeBlond for redOrbit.com – Your Universe Online.

Samuel Eto’o Takes his Bugatti Veyron Out for a Spin in Paris

Soccer star Samuel Eto’o spends his exorbitant pay and free time living the life of a boss.

Cameroonian soccer star and former Inter Milan and Barcelona FC standout Samuel Eto'o was spotted cruising around the streets of Paris in his Bugatti Veyron. The Anzhi Makhachkala star is the best paid soccer player of African descent.

According to the BBC, Russian team Anzhi Makhachkala paid Inter Milan €21 million (about $27,800,000) for his contract and they are paying him a yearly salary of €20 million (roughly $26.5 million) after tax per season. This makes him a higher earner than Lionel Messi or Cristiano Ronaldo.He has found a terrific hobby to spend all that cash, as in addition to owning this Bugatti Veyron he also owns a Gemballa Mirage GT and Stallone Mansory. The super-spending Russian club, recently bought by billionaire oil tycoon Suleiman Kerimov, has seen a solid return on their investment, as Eto'o has already scored 8 goals in 14 appearances this season

Sleep Needed By Police Officers For Performance And Health Issues

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Forget bad guys and guns: Being a police officer can be hazardous to your health in so many different ways.

Researchers at the University of Iowa have found that police officers who slept for fewer than six hours per night are more susceptible to chronic fatigue and health problems, such as being overweight and contracting heart disease and diabetes. The study found that officers working the evening or night shifts were 14 times more likely to get less restful sleep than day-shift officers, and also were on duty for more back-to-back shifts, making their sleep deficit even worse.

The study is the first peer-reviewed look at differences in duration and quality of sleep in relation to shift work and health risks in police departments, the authors noted.

“This study further confirmed the impact of shift work on law enforcement officers and the importance of sleep as a modifiable risk factor for police,” wrote Sandra Ramey, assistant professor in the College of Nursing at the UI and the lead author on the paper published in Workplace Health & Safety. “The good news is this is correctable. There are approaches we can take to break the cascade of poor sleep for police officers.”

The research is important because getting fewer than six hours of sleep could affect officers’ ability to do their jobs and affects public safety. It also boosts the risk for health problems, which could affect staffing and could lead to higher health costs passed onto taxpayers.

The researchers recommend putting practices in place to ensure officers get proper sleep. For example, 83 percent of police on the evening or night shift reported having to report to duty early the next morning at least occasionally. One idea from the UI team is to change the morning time that evening or night-shift officers may need to appear in court, to ensure that they get full rest. It is recommended to partner officers and nurses more closely to encourage 7-8 hours of sleep per night.

The researchers surveyed 85 male police officers from three police departments in eastern Iowa ranging from 22 to 63 years old. The respondents were equally divided between those who worked the day shift and those who worked the evening or night shifts. The officers, who worked an average of 46 hours per week, were questioned on their levels of stress and fatigue, while their height, weight, and C-reactive protein levels (marks inflammation levels in the blood) were measured.

While officers working the evening or night shifts were more likely to get fewer than six hours of sleep, the researchers also found that police who slept fewer than six hours were twice as likely to sleep poorly. That finding is important, because poor sleep can lead to “vital exhaustion,” or chronic fatigue, the authors noted which can trigger additional health problems.

The UI study builds on other studies that show a possible link between sleep deprivation and ill health and chronic fatigue in police officers. “This finding is supported by other studies that suggested poor sleep and short sleep (with resultant fatigue) may be related to psychological stress,” they wrote.

Surprisingly, the researchers did not find a strong tie between the onset of health complications and lack of sleep, although they said a larger statistical sample may be needed to more fully understand the relationship.

Source: redOrbit Staff & Wire Reports - Your Universe Online

How Does Twitter Verify Celebrity Accounts?

If you're well known or downright famous, you might consider getting your Twitter account verified so that followers know that you're the real deal. Be aware that this service is not offered to the public anymore and is only available to Twitter partners and advertisers, in addition to accounts of highly famous public figures that deal with identity confusion on the site.

While Twitter continues to give celebrities, athletes, musicians, actors and others a platform to directly connect with their fans, the social networking site remains tight-lipped about how it determines if those stars are really who they say they are.

The real Charlie Sheen joined Twitter on March 1. Prior to that, an imposter or “squatter,” as Twitter refers to those tweeting under a false name, had secured the handle @charliesheen. The faux Sheen was quickly removed and the former “Two and a Half Men” star slipped into the handle with a “verified” blue check on his account. He now has more than two million followers.

Twitter has 175 million users and counting and only select, mostly high-profile people are granted “verified” status. How are verified users vetted? Twitter refused to explain the process, saying via e-mail, “we continue to very selectively verify accounts most at risk for impersonation on a one-off and highly irregular basis.”

But what does that actually mean?

Comedian Dane Cook (@danecook) said he “hit a few 100,000 followers and one day it was just verified.” Adam Leber, Britney Spears’ manager said, “we reached out to the head of Twitter to verify ourselves.” The musicians’ account (@britneyspears), which several people including Spears, her assistant, and Leber all post to, received a blue check shortly after the request was made.

The “verified” status, according to Cook, “gives fans an opportunity to know this is 90 percent the real guy, his real account.”

For “The Vampire Diaries” actor Ian Somerhalder (@iansomerhalder), who’s in the process of creating his non-profit, the Ian Somerhalder Foundation, being verified eliminates the possibility of account misuse. “I never want anyone on the twitterverse to think I’m selling anything. It’s just about being honest with people.”

However, if you (or your boss/client) fit the bill, here is how to go about getting your Twitter account verified.

Steps

1. Determine if you qualify for a verified Twitter account. Twitter verifies as few accounts as possible and only for legitimate reasons. Reasons for asking Twitter include being a highly recognizable public figure (athletes, artists, public officials, public or government agencies, etc.), or if your name and likeness is parodied or impersonated on multiple Twitter accounts, leading to identity confusion.

o             Though Twitter does not have an official stance on this, several Twitter-verified companies have indicated that spending $5000/month on Twitter advertising will also get (and keep) your account verified.

o             Twitter will not consider you for verification based on your number of followers. Twitter urges Tweeters to "Please note that follower count is not a factor in determining whether an account meets our criteria for verification.

o             Twitter recommends embedding a Twitter "Follow" button on your official website as the best alternative to verification. This allows you to obtain followers directly from your official site, which is very helpful if there are multiple Twitter accounts that use your name.

o             Twitter also recommends including a link to an official website as an alternative to verification.

2. Read the Verified Account terms. These terms explain what a verified account is, what it means to be verified, who has the verified badge, identifying a verified account, etc.

3. Find out how to apply for a verified account. Send a direct message to https//twitter.com/♯!/verified and be sure to have the following information ready.

o             Account name

o             Full name

o             Location

o             Official website (you will be given a suggestion to put the Twitter logo or badge on your official website to speed up verification)

o             Bio information (information about yourself in fewer than 160 characters)

o             Primary contact name (referring to the individual who manages the account)

o             Additional Contact Information

4. Wait for Twitter to respond. If you don't get a reply shortly, you can contact Twitter by snail mail or through Twitter. Keep in mind that Twitter deals with a high volume of verification requests, and that it focuses first on the most "highly sought users.

5.Do not change your account information. Once you have received a verification badge, it is important to keep your account information the same. Changing information, such as your profile image, can cause Twitter to remove the badge, forcing you to contact them again