Companies & Sectors
FDA Reins In Labeling of 'Low T' Drugs
Agency calls on drugmakers to add certain health risks to label
 
Noting a potentially dangerous trend in the overprescribing of testosterone products to men whose symptoms are merely the result of normal aging, the Food and Drug Administration (FDA) last week moved to rein in the marketing of such low testosterone or “Low T” treatments. 
 
“Aging men can […] experience signs and symptoms such as decreases in energy level and problems with sexual function, but it is uncertain whether these are caused by the lowered testosterone levels or due to normal aging,” the agency said. The FDA warned that prescription testosterone products have not been proven safe or effective for treating common signs of aging.
Marketers of testosterone products pitch their drugs to men troubled by a decreased sex drive, moodiness or low energy, urging them to talk to their doctor about Low T.
 
But even for men whose medical condition is approved for a testosterone prescription through a diagnosis of disease or injury, the FDA warns that there are potential health risks, including a possible increased risk of heart attack and stroke.
 
Now, in addition to calling on drugmakers to change their labeling to clarify the approved uses of their medications, the FDA wants these risks added to the label and a clinical trial looking into the potential side effects on the part of the drugmaker.
 
A spokesperson for Endo Pharmaceuticals, which makes several testosterone products including Testim, said in an email to TINA.org that the company will work with the FDA to ensure that its drugs are “prescribed to the appropriate patient population, as deemed by the [a]gency.” 
 
TINA.org also reached out to AbbVie, which makes AndroGel, but has not yet heard back from the company.
 
The use of testosterone products has skyrocketed in recent years, from 1.3 million patients receiving a prescription in 2009 to 2.3 million in 2013, according to the FDA. The popularity of these products — which come in gels, patches and injections, among other formulations — has generated sales topping $2 billion.
 
But the surge in prescriptions has also led to an onslaught of lawsuits, some of which claim that the drugs do not adequately disclose the risks associated with taking them.
 
For more of our coverage on low testosterone products, click here
 

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Yes, Black America Fears the Police. Here’s Why.

Shots were fired in Long Island, but there was no rush to call 911. US had seen witnesses treated like suspects, and knew how quickly black people calling the police for help could wind up cuffed in the back of a squad car 

 

This story was co-published with Politico Magazine

 

Last July 4, my family and I went to Long Island to celebrate the holiday with a friend and her family. After eating some barbecue, a group of us decided to take a walk along the ocean. The mood on the beach that day was festive. Music from a nearby party pulsed through the haze of sizzling meat. Lovers strolled hand in hand. Giggling children chased each other along the boardwalk.
 
Most of the foot traffic was heading in one direction, but then two teenage girls came toward us, moving stiffly against the flow, both of them looking nervously to their right.
 
“He’s got a gun,” one of them said in a low voice.
 
I turned my gaze to follow theirs, and was clasping my 4-year-old daughter’s hand when a young man extended his arm and fired off multiple shots along the busy street running parallel to the boardwalk. Snatching my daughter up into my arms, I joined the throng of screaming revelers running away from the gunfire and toward the water.
 
The shots stopped as quickly as they had started. The man disappeared between some buildings. Chest heaving, hands shaking, I tried to calm my crying daughter, while my husband, friends and I all looked at one another in breathless disbelief. I turned to check on Hunter, a high school intern from Oregon who was staying with my family for a few weeks, but she was on the phone.
 
“Someone was just shooting on the beach,” she said, between gulps of air, to the person on the line.
 
Unable to imagine whom she would be calling at that moment, I asked her, somewhat indignantly, if she couldn’t have waited until we got to safety before calling her mom.
 
“No,” she said. “I am talking to the police.”
 
My friends and I locked eyes in stunned silence. Between the four adults, we hold six degrees. Three of us are journalists. And not one of us had thought to call the police. We had not even considered it. 
 
We also are all black. And without realizing it, in that moment, each of us had made a set of calculations, an instantaneous weighing of the pros and cons. 
 
As far as we could tell, no one had been hurt. The shooter was long gone, and we had seen the back of him for only a second or two. On the other hand, calling the police posed considerable risks. It carried the very real possibility of inviting disrespect, even physical harm. We had seen witnesses treated like suspects, and knew how quickly black people calling the police for help could wind up cuffed in the back of a squad car. Some of us knew of black professionals who’d had guns drawn on them for no reason. 
 
This was before Michael Brown. Before police killed John Crawford III for carrying a BB gun in a Wal-Mart or shot down 12-year-old Tamir Rice in a Cleveland park. Before Akai Gurley was killed by an officer while walking in a dark staircase and before Eric Garner was choked to death upon suspicion of selling “loosies.” Without yet knowing those names, we all could go down a list of unarmed black people killed by law enforcement. 
 
We feared what could happen if police came rushing into a group of people who, by virtue of our skin color, might be mistaken for suspects. 
 
For those of you reading this who may not be black, or perhaps Latino, this is my chance to tell you that a substantial portion of your fellow citizens in the United States of America have little expectation of being treated fairly by the law or receiving justice. It’s possible this will come as a surprise to you. But to a very real extent, you have grown up in a different country than I have.
 
As Khalil Gibran Muhammad, author of The Condemnation of Blackness, puts it, “White people, by and large, do not know what it is like to be occupied by a police force. They don’t understand it because it is not the type of policing they experience. Because they are treated like individuals, they believe that if ‘I am not breaking the law, I will never
be abused.’”
 
We are not criminals because we are black. Nor are we somehow the only people in America who don’t want to live in safe neighborhoods. Yet many of us cannot fundamentally trust the people who are charged with keeping us and our communities safe. 
 
 
Courtesy: ProPublica.org 
 

 

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'Women are no longer proxies,' says Nirmala Sitharaman
Speaking at the Women's Day celebration at Moneylife Foundation, the Union minister for Commerce and Industries said women entrepreneurs are keen on adopting new technologies to reach out to the world, and it is for Digital India and institutional funding to reach them
 
Union minister for Commerce and Industries, Nirmala Sitharaman said that women are no longer proxies and are taking their own decisions, either in politics or entrepreneurship. "Women are no longer shadows of men. In business, women do cost-benefit analysis in most ruthless analyses. Therefore it is only beneficial to enhance their role in business and entrepreneurships by using digital media," she said, while speaking at the International Women's Day organised by Moneylife Foundation in Mumbai. The programme was sponsored by Titan.
 
The Minister also felicitated two extraordinary activists, Dr Maria Barretto, CEO of the Parkinson's Disease and Movement Disorder Society (PDMDS) and Shaheen Mistri, founder of Teach for India and Akanksha Foundation.
 
Talking about enhanced role of women in changing times, Ms Sitharaman, said, "Earlier women were assumed to be proxies for either their male relatives. However, this is rapidly changing. Especially, during my frequent visits to some Southern states, I often found women asking questions on development. In fact, in local panchayats and gramsabhas these women representatives have brought development agenda at the forefront."
 
 
Describing how women in rural areas are now coming forward to adopt technology to reach to the outer world, Ms Sitharaman, said, "When I proposed to build a community hall for women at these places, one woman asked me whether it will have computers as well. The woman told me that she wanted her daughter to help her through the computers and internet and not her son, who was working in the city. This, however, is just one of the several examples, how women from rural areas are keen on adopting technology to grow their business".
 
Last year, the minister adopted two villages Pedamainavani Lanka and Thruputalla villages in West Godavari district under the Prime Minister's 'Sansad Adarsh Gram Yojana'.
 
Referring to a National Sample Survey Office (NSSO) report, Ms Sitharaman said, "Over half the country's workforce is self-employed. Out of this, about 8.9% are rural women, while the percentage of self-employed women in urban area is just over 1%. In short, about 10% women are self-employed. But, there are no facilities, like funding, obtaining registrations and other necessary permissions from government bodies. Nothing is available for them and even they do not get easy help."
 
"Women are already making a difference. However, they are not cared. In this situation, institutional mechanism, funding, like Mudra Bank, need to not only help but also help them understand the nitty-gritty of the trade, business," Ms Sitharaman added.
 
"Digital India, the one step shop for government services, needs to reach these women entrepreneurs in rural areas," the minister said, adding, "Women are not shy of new technologies. They want to be on the Internet. They want the world to see their business. So it is up to us, how we can provide them facilities like computers and internet so that the products from these women entrepreneurs reach to better markets."
 
Digital India, an initiative of the Narendra Modi government promises to transform India into a connected knowledge economy offering world-class services at the click of a mouse and will be implemented in a phased manner.
 
Sucheta Dalal, Founder-Trustee of Moneylife Foundation pointed out the dangers about people losing their lifetime earnings as well as also faith in financial services, if somebody misuses their debit card or online accounts. With the rapid spread of mobile internet and RuPay debit cards through PM Jan Dhan Yojana, these dangers are now lurking towards a large population, she added.
 
Replying to the question, Ms Sitharaman, said, "I agree that one wrong thing or failure can finish an individual financially. It is risky as a Ponzi scam, where there is no out. Therefore, we need to have some safeguards in place; the system needs to have an element of trust. We may think to have an insurance cover for such mishaps." 
 
Shaheen Mistry founded the first Akanksha Center in 1989, enrolling fifteen children and persuading college friends to volunteer. It eventually evolved into the Akanksha Foundation, a non-profit education project that provides after-school tutoring to disadvantaged children at more than 60 centres, formal education at six schools in Mumbai and Pune for 4,500 students. 
 
Teach for India was launched in 2008. With sheer conviction and enthusiasm, Shaheen has motivated hundreds of college students and young professionals to join the Teach for India movement and devote two years of their lives to end educational inequity in India. Transforming the US concept to a system as complex and diverse as India was, as one can imagine, a huge challenge. Over the years, Teach for India has recruited 1,700 enthusiasts for its two-year teaching Fellowship. 
 
Dr Maria Barretto has devoted her life to helping people suffering from Parkinson's Disease. She empowers them to live a good quality life and ensures that the dreaded, debilitating Parkinson’s disease does not get people to the point that they give up their normal life. At PDMDS, she developed a 'community based multidisciplinary model of care' to reach out to patients of Parkinson's who have limited or no access to medical care.
 
At the end, Nirali Kartik enthralled the audience with her beautiful voice. She sang on a theme, "Mrig Nayanee- A Woman's Eyes and Expression". She started the session with Ja Ja Re Apne, a famous bandish in Raag Bhimpalasi, followed by song expressing various moods of Radha, Kaali in Dhrupad style, a Holi song, and a Sufi song before ending it on a high note with popular songs like Chhap Tilak and Duma Dum Mast Kalandar.
 

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COMMENTS

Rangarajan Tnc

2 years ago

There is a point about income tax which requires attention.
Many husbands invest their savings in the name of their wife. Under section 64 of the Income Tax Act the income from those investments are added to the husband's total income and taxed at the highest rate. Nirmala Seetharaman says that women are not proxies but the Income Tax Act treats them as such. The quirk is that the asset does not belong to him and she can do what she likes with the income but he has to pay tax on that. Many people may not know about this position and are likely to be blackmailed by some bad taxman. When a working wife is entitled to tax free income of 2,50,000 why not a wife who is given money by her husband which is not only out of love but also as a recompense for all the domestic services that she renders.
It is high time that section 64 is repealed. This will reduce the artificial tax burden on men who don't insist on the wife earning income.

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