Regulatory Conference Shows The Way Forward From Lessons Learnt In The Past

The 4th Open Forum Conference was held in Addis Ababa, Ethiopia on 18th and 19th August to address key issues in developing new drugs for tuberculosis, which kills nearly 2 million people every year and is becoming increasingly resistant to the current drugs. The conference, with a special focus on Africa, brought together regulators, scientists and other interested stakeholders, from all around the world, to share knowledge and build a proper infrastructure needed to adopt new and improved TB treatments. They deliberated over an innovative drug development model which will reduce the usual time taken to develop safer and more effective TB drug regimens by almost 75%.

New drugs development for TB treatment seemed to have been stalled until a decade ago, with no new treatments in the pipeline. But thanks to the initiatives taken by the Global Alliance for TB and due to investments in TB research by global funders, there are, at present, 10 new compounds in the pipeline, three of which are in clinical trial stages.
Mel Spigelman, MD and CEO of the TB Alliance agreed that "Today there is unprecedented hope for better treatments for tuberculosis. Now that there are promising compounds in the global pipeline, it is important to speed them through clinical development so they can reach the millions in need."

Since the 1950s, researchers have known that in TB treatment (or for that matter, treatment of other diseases as well), mono therapy is dangerous as it creates drug resistance. So, to be effective, it must be delivered in multidrug regimens. Moreover, the current TB therapies are long and complicated, and also incompatible with commonly used HIV infection. The current treatment, for drug sensitive active disease, uses 4 drugs which need to be administered daily for at least 6 months. Treatment for multidrug resistant TB (MDR) is still longer and requires more expensive and toxic drugs.

Under the traditional paradigm, TB drugs were developed and registered separately, and substituted/added one at a time, into existing combination therapies. For each substitution, the drug had to be tested in clinical trials, which normally takes 6 years. So, a novel four drug therapy would have required a minimum of 24 years, before it could benefit those who needed it urgently.

The new TB drug development model focuses on testing novel combination-drugs together in the development stage, rather than individual drugs. This would drastically reduce the development time for building new regimens.

"This collaboration harnesses innovation to speed availability of a shorter and more effective treatment for TB," says Margareth Ndomondo Sigonda, pharmaceutical coordinator of the New Partnership for Africa’s Development. "It is important for global regulators to harmonize regulatory guidance and provide efficient regulatory processes for new TB regimens to speed adoption and make an impact."’

The Minister of Health of Ethiopia rightly believes that, "New technology and innovation are necessary to defeat tuberculosis. This event is important because Africa’s regulators, systems, and, above all else, people, must be prepared to fully maximize the promising innovations coming through the pipeline."

This innovative model is part of a wider programme called the ‘Critical Path To TB Drug Regimens (CPTR)’ which was launched by FDA Commissioner Margaret Hamburg on March 17, 2010, and is led by the Bill and Melinda Gates Foundation, the TB Alliance, and the Critical Path Institute. It aims to reduce the broad obstacles facing TB drug development.
The take home messages after two days of intensive deliberations, reiterated that the diagnosis, treatment and care of tuberculosis continues to be immensely challenging, not only in the context of Africa, but other countries too, having a high burden of the disease. On the one hand, inadequate resources are impeding development/testing of new drugs while on the other hand, weak health systems are constraining time bound deliverables to the affected community. However, in this dismal scenario, there have been a few success stories too (in Lesotho, Georgia and Ethiopia). As Dr Spigelman rightly said, "Big progress comes from small numbers."

According to him, the way forward has three major components:
(i) A strong political will, which is committed to take care of public health. Without this key element the fruits of labour of developers of new drug regimens will not be able to reach the affected community.
(i) Innovations, to optimize the use of the limited resources available. An innovative approach to make the system work more efficiently will result in ‘doing more with less’.
(ii) Linkage, of all the individual areas of expertise of experts from diverse fields. Researchers, pharmaceutical developers, regulatory agencies and civil society organizations - all need to work not only in their individual capacities, but also together. Everyone needs to be informed about what everyone else is doing.

Only then will it be possible to overcome obstacles and speed up the urgently required new TB regimens to reach the people who need them most.
Together we shall overcome one day, which is not far away. (CNS)

Shobha Shukla – CNS
(The author is the Editor of Citizen News Service (CNS). She has worked earlier with State Planning Institute, UP, and teaches Physics at India’s prestigious Loreto Convent. Email: shobha@citizen-news.org, website: www.citizen-news.org)

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Hindus laud Nashville’s Frist Center for organizing travelling exhibition on Vishnu

Frist Center for the Visual Arts of Nashville (Tennessee, USA) is organizing travelling exhibition on Vishnu.
Applauding Frist Center for focusing a travelling exhibition on Lord Vishnu, Hindu statesman Rajan Zed, in a statement in Nevada (USA) today, said that art had a long and rich tradition in Hinduism and ancient Sanskrit literature talked about religious paintings of deities on wood or cloth. Zed commended Frist Center for providing an opportunity to the world to further explore Hinduism and its concepts.

Titled “Vishnu: Hinduism’s Blue-Skinned Savior”, it will open in February next and shall present about 120 paintings and sculptures made in India going as far back as fourth century CE. According to Center, this exhibition will serve as a brief survey of Hindu art styles as well as an examination of the Vaishnava tradition. The first section of the exhibition will introduce Vishnu in his primary form with subsections dedicated to his attributes, legends, etc. The second section will examine his avatars (incarnations), as a group and then individually, with substantial subsections dedicated to Rama and Krishna. The third section will show some of the ways that Vishnu has been worshipped, with images of temples and ritual objects.

This exhibition, arranged by Dr. Joan Cummins, Asian Art Curator at the Brooklyn Museum (New York, USA), will be accompanied by a fully illustrated catalogue with essays and object entries by Cummins and other distinguished scholars in the areas of religious studies and anthropology. Starting at Frist Center from February 25 to May 29 next year, it will move to Brooklyn Museum from June 24 to September 28. Workshops will be organized regarding this exhibition on March nine and 12.

Rajan Zed, who is President of Universal Society of Hinduism, urged major art museums of the world, including Musee du Louvre and Musee d’Orsay of Paris, Metropolitan Museum of Art in New York, Los Angeles Getty Center, Uffizi Gallery of Florence (Italy), Art Institute of Chicago, Tate Modern of London, Prado Museum of Madrid, National Gallery of Art in Washington DC, etc., to frequently organize Hindu art focused exhibitions, thus sharing the rich Hindu art heritage with the rest of the world.

The Frist Center, whose vision is “to inspire people through art”, has hosted a spectacular array of art from the region, the country, and around the world. William R. Frist is Chairman of Board of Trustees. Vishnu is “preserver” in the Hindu triad with Brahma and Shiva as the aspect of the Supreme. He had ten incarnations to establish dharma (divine law).

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Duggar family : 12 Duggar Children Get Chicken Pox At The Same Time!

The Duggar family never does anything on a small scale. Jim Bob and Michelle have 19 kids. They have a 7,000 square foot house. And now, 12 of their children have the chicken pox, and RadarOnline.com has the exclusive video clip of the adorable kids coping with the childhood infection from the next episode of 19 Kids and Counting.

"Johanna broke out with chicken pox a couple weeks ago and now we have 11 more who broke out," dad Jim Bob says in the video as he leaves a phone message for the doctor.

Mom Michelle explained that the timing of the outbreak was right before they were going to bring little baby Josie back home, but they decided she would stay with her in Little Rock until the kids were chicken pox free.

Popularity: 3% [?]

Tuberculosis And Poverty: Partners By Default

There is a direct link between TB and poverty. It is indeed a vicious cycle, as one begets the other. The stark reality is that tuberculosis saps the economy of the community, which in turn increases the likelihood of contracting TB. This point emerged several times during the recently concluded Open Forum 4: Critical Path to TB Regimen: New Hope of Life for TB Patients, which took place in Addis Ababa, Ethiopia. The meet was organized by TB Alliance with support from the Bill and Melinda Gates Foundation, the Stop TB Partnership Working Group on New Drugs, Treatment Action Group among others.

The economic impact of tuberculosis is staggering. It is estimated to rob the world’s poorest countries of an estimated USD 1 to USD 3 trillion over the next 10 years. 94% of the TB cases and 98% of TB deaths occur in developing countries – and often amongst the poorest in those countries. Also, a large majority of TB patients belong to the age group of 15-54 years, which are the most productive years of one’s life.

The WHO estimates that the average TB patient loses 3 to 4 months of work time and up to 30% of family earnings per year. Entire economies are affected. The burgeoning cost of TB medical care further compounds the problem, putting a constant drain on resource-depleted health systems.

Dr Jeremiah Chakaya, who heads the DOTS Expansion Working Group of the Stop TB Partnership, echoed similar sentiments saying that a partial solution to controlling and preventing TB is to reduce poverty. Economic self sufficiency almost invariably results in healthier diets and better living conditions, which in turn increases the resistance of the body and improves the immune system.

So, a faster and better cure could provide immediate benefits. A shorter drug regimen would reduce lost work time and decrease the economic burden on the patient and the family. Fewer visits to the doctor would ease the burden on tottering health systems, and funds could be redirected to basic health care and TB control programmes.
Simpler diagnostic and treatment tools will result in savings and make the healthcare systems more efficient. Dr Mel Spigelman, MD, CEO of the TB Alliance stressed upon the importance of improving the quality of health care systems. He said that tuberculosis is indeed a disease of the poor. He agreed that some life style changes may trigger off the disease. Yet most of it occurs in non smokers and non diabetics. He said that there was evidence that every time after an economic downturn, TB incidence worsens.

The side effects of TB medicines are devastating, more so in the case of MDR TB, or in those suffering from TB and HIV. Poverty results in severe malnutrition, as patients cannot afford a proper, nutritious diet. This further increases the chances of co infection. A healthy diet and properly ventilated living spaces are very important in management of the disease.

Barriers to adherence of the drug regimen are socioeconomic. Francis George Apina, a TB/HIV Advocacy Manager and a patient representative from Kenya, voiced the sentiments of many when he lamented that "TB deprives families/communities, resulting in increased poverty and a sense of hopelessness. The long length of treatment, the severe side effects, and the far away location of the nearest health centre very often result in the patient discontinuing treatment and becoming more prone to MDR/XDR TB which is more costly to treat. An over burdened health system cannot deal with these socio economic problems. So the patients are sent back home—to infect more people in the process."

Francis pleaded for the need of new TB drugs, which can rapidly kill the TB bacilli with fewer side effects and which are also compatible with ARVs. He appealed to the fund managers, researchers, drug manufacturers and regulators to help speed up this process

There is an urgent need for more robust drugs to address the challenges and unmet needs in TB therapy. According to Dr Brian Woodfall, head of the Medical Department at Tibotec, successful drug development is not achieved till new cures reach the affected communities. Such a drug should comply with the four As— Affordability, Adoption, Availability, and Appropriate use.

So, in the words of Francis Apina, "We need a game changer in new TB drugs development like never before. For people living with HIV and their families, the search for new TB drugs - especially those that can be taken with anti retroviral drugs—is a race against time."

Thus future regimens for TB treatment should be more patient friendly, by being cheaper, safer and by drastically reducing treatment time. A faster and simpler cure for TB will save lives and have tremendous global benefits. It would improve treatment compliance (thus preventing the emergence of the deadlier drug resistant strains) and allow more patients to be treated.

This is exactly what organizations like the TB Alliance and its partners are striving for. Thanks to the untiring efforts of several agencies, today the global portfolio includes 9 new TB drugs in clinical stages of development, three of which are part of the TB Alliance’s portfolio.

There are still miles to go before we can rest and sleep. But well begun is half done. The time has come for novel TB regimens to be realistically conceived and accomplished. We all hope that CPTR will make a positive difference in the lives of millions of TB patients all over the world. (CNS)
Shobha Shukla – CNS

(The author is the Editor of Citizen News Service (CNS) and also serves as the Director of CNS Gender Initiative and CNS Diabetes Media Initiative (CNS-DMI). She has worked earlier with State Planning Institute, UP, and teaches Physics at India’s prestigious Loreto Convent. Email: shobha@citizen-news.org, website: www.citizen-news.org)

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Eminem Surpasses 10 Million Facebook Fans

Eminem, Marshall Mathers, Slim Shady…has surpassed 10 million fans on Facebook, according to Famecount.

He becomes only the second living musician to have done so - behind Lady Gaga - whose recent smashing of the 10 million fan barrier was well documented and now boasts more than 15 million Facebook fans. So far only 4 total musical entities have made it passed the 10 million worldwide Facebook fan mark, and it is indeed an elite group. Deceased musician Michael Jackson leads the charge with 18.3 million fans, followed by Lady Gaga (15.3 million), and Linkin Park (10.3 million). 

Lil Wayne currently leads the “Best of the Rest” with a total of 9.7 million fans.

The ranking represents a return to the top of the industry for the reformed star, who confesses in the first single from his most recent album Recovery that his previous album, Relapse, represented less than his best work.

“Eminem’s base of over 10 million Facebook fans is currently growing 4 times as fast as the global Facebook average according to social media monitoring tool Famecount.com,” said Jamie Gavin, Founder and Senior Digital Media Analyst at Jay-G Media. “This makes him one of the fastest growing Facebook entities in the world. Additionally, the star’s online fan base of 1.3 million Twitter followers and 158,000 YouTube channel subscribers make him the 16th most famous social media entity anywhere in the world on an aggregated basis.

With his latest single, Love the Way You Lie – a haunting collaboration with fellow Facebook top 10 ranked music star Rhianna – sat firmly at the top of the U.S. singles chart, Eminem’s online popularity looks set to grow even further as he appeals to a whole new generation of music fans.

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Youth almost crushed to death; By-standers laugh

Bengaluru: In a shocking incident, a young man of 21 years age was almost crushed between the hydraulic doors of a Marco Polo bus in Bangalore on Sunday evening, the 1st August 2010.

Prannoy David Roy, a resident of Kaggadasapura, Bengaluru was returning after attending a mass at Indiranagar when the incident happened. Rao boarded the bus numbered 314 E bearing registration number KA 01 F 4550 at around 7:30 PM.

Rao had attended a mass at the Indiranagar Methodist Church and after he headed to the Sapna Book House and from there waited for a bus to Kaggadasapura. When the bus arrived, Rao waited for people to get off the bus before he boarded. He was halfway through the door when the hydraulic door closed and Rao was crushed at shoulders and chest.

He kept shouting but the driver took 30 seconds to react and finally when Rao managed to come out of the clutches of the door, the conductor started scolding him for not embarking in time. Rao retorted back, “But I was waiting for the people to get down, how could I board?” Rao’s pleas fell on deaf ears.

Shocking response:

However, what was more shocking than the above callous behavior of the Govt. servants was the reaction of the few bystanders who were laughing at the condition of the man instead of helping him.

“I told them this was not a laughing matter. If it had been an old woman or child in my place, they could have died. Despite my condition, no one bothered to either speak to the conductor or give me a seat,” he said.

Mithun Kumar, Men’s Rights Activist from Bengaluru reacting sharply to the attitude of the fellow passengers said, “Everyone has only expectations from young men but no one understands their problems and pains. The real issue is the lack of awareness of men’s issue and unnecessary negative portrayal of men in media and otherwise. These problems can only be solved if men too have a ministry for their welfare and a national commission for themselves. The Govt. of India should think about it”

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The French First Lady’s, first film hits the floor, but will it meet its completion deadline?

Carla Bruni- Sarkozy, the French First Lady and the former model and pop singer has just begun her new profession, that of an actress. She’s started filming Woody Allen’s new film ‘Paris in Midnight’.

Woody Allen who is known for writing and directing sex comedies had approached the French First Lady for a cameo role in his film ‘Paris in Midnight’ back in 2009. The film also stars Owen Wilson, Marion Cotillard, Rachel McAdams, Kathy Bates, Michael Sheen.

The movie which is scheduled for release in 2011 has just begun shooting and the First Lady was spotted in front of the cameras earlier this week. Though the shoot for the same has begun on time, the way things were moving at the shoot gave one doubts whether it would get finished in time.

Reportedly the French First lady is anything but a good actress ; a simple shot of her could be completed only after 35 re-takes. And this was a shot in which the first time actress didn’t even have any lines to speak, all she has to do is enter and exit with a baguette. “She seemed to be struggling to avoid looking directly into the camera, which didn’t impress Woody,” a source stated. “The baguette scene could not have been simpler, but she wanted to make it a big one”, he added.

Despite the numerous takes a source stated that ‘Woody and Carla got along well and laughed quite a lot between takes’. As if the poor director has any choice, after all the lady was surrounded by her security guards.

But if this is the speed at which the movie shoot will flow, we doubt it will meet its completion and release deadline. All the best Woody!

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After two failed matrimonial alliances, will NDTV Imagine still manage participants for its reality show ‘Swayamvar’?

NDTV Imagine, a general entertainment channel on Indian Television, had broadcasted a new reality show in 2009 titled ‘Rakhi ka Swayamvar’, in which they had an item girl of Bollywood, Rakhi Sawant select her groom from 20 contestants. At the end of the show Rakhi ended up selecting one Elesh Parjunwala, a Canadian business man from Toronto as her to be bridegroom. The two were to tie the knot on TV immediately, but it was announced that duo were interested in tying the knot a little later and the show hence ended on a happy note with the couple’s engagement on national television. However a few weeks after the show ended, Rakhi Sawant announced she was not marrying Elesh as she wasn’t interested in quitting her acting career in India and settling in Canada.

The Season 2 of the reality show was aired in the beginning of this year and was titled Rahul Dulhaniya Le Jayega. The show featured Rahul Mahajan as the groom looking for a bride this time. Rahul Mahajan is the son an ex- BJP politician-Late Pramod Mahajan and a reality show personality. At the time of participating in this show Rahul’s background had nothing much to boast of. In fact he was known more for his notorious acts like being involved in drug possession and consumption and being accused of domestic violence by his ex-wife. Yet to our surprise there were 17 girls who were going all out too woo this man and to get married to him.

Rahul selected Dimpy Ganguly, a girl 15 years younger to him to be his bride. Dimpy was a Bengali model and actress. This time the channel even managed to get the couple to marry on live Television in March. But the wedding apparently has neither lasted long nor ended on a happy note. Reportedly Dimpy has walked out of Rahul Mahajan’s life yesterday after accusing him of domestic violence.

Dimpy has stated that she was often beaten up by Rahul, but on Thursday he went overboard. She said he punched, kicked and dragged her by her hair, and that’s when the ex-model decided to quit her 4 month marriage to him. So much so, for a wedding that was witnessed by millions on National Television.

NDTV Imagine who had earlier announced that they were working on the format for the third season of this show, will hopefully re-think before creating another alliance that in all possibility will not work. And even if they go ahead with the third season, will they get participants this time? We assume they will, after all there is no dearth of publicity hungry people. Elesh and Dimpy, we are positive, were both aware of what they were getting into, but went ahead for the sake of publicity alone.

Popularity: 8% [?]

Apple sued by a consumer for iPad overheating issues in sunlight

Apple is one of the world’s most renowned brands; consumers all around the world always keep an eye on all the apple products. Now Apple was sued by an iPad owner, who claims that iPad turns off after few minutes when it gets too hot.

Apple has been sued on 23 July in U.S. District Court in Northern California. It claims the iPad “does not live up to the reasonable consumer’s expectations created by Apple” because it “overheats so quickly under common weather conditions” as reported by Bloomberg. The Apple iPad has so many amazing features with 9.7-inch touch screen display and it also includes Internet browsing, email, photos, videos, music, games and reading newspapers and books.

There are other people who has also faced same sort of issues, for example PC Magazine editor Zach Honig who took his iPad in sunlight and after 10 minutes iPad shut down with the message “iPad needs to cool down before you can use it.” Zach Honig said this on Twitter.

Apple iPad is used by many people around the world & Apple has already sold more than three million iPads. If you are reading this article and want to share your thoughts, please post your comments below.

Popularity: 4% [?]

Apple iPhone topped on the charts & Voted "Coolest Thing on the Planet"

It is coolest and sensational news for Apple iPhone Users and Lovers, Apple’s iPhone has been voted “The coolest thing on the planet” leaving all other gadgets, web sites, applictions etc behind.

A survey of 3,000 Brits saw the iPhone just ahead of its maker Apple, which was at the second place. The ipod gets the fourth place position; the third coolest thing was the internet according to the Costa Coffee study. Facebook which was recently much hyped because of its count of 500 million users is at tenth place. You would be amazed too see that Google Earth is at 11th place.

The list of top 10 coolest things on the planet is:

1.  iPhone
2.  Apple
3. The internet
4.  iPod
5.  Aston martin DB9
6.  Cadbury’s chocolate
7.  Sky+
8.  eBay
9.  Mobile phones
10. Facebook

Apple iPhones are mostly famous for their designs and amazing new features. We also agreed that Iphone is the coolest in the world of hit-tech gadgets. Apple iPhone rocks the tech world! Please give your genuine views & opinion on this poll & speak out what you think is the coolest thing on the planet?

Popularity: 1% [?]

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