Drug trials causing 'havoc' to human life, Supreme Court says

NEW DELHI: The Supreme Court said Thursday that unregulated clinical trials of new drugs were causing "havoc" in the country as it ordered the health ministry to monitor any new applications for tests.

The comments were made during a hearing on a petition detailing deaths and health problems caused by clinical trials carried out on Indians, often without their knowledge or consent.

"Uncontrolled clinical trials are causing havoc to human life," Justice RM Lodha observed.

"There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far."

The judge, who has previously stated that Indians are being used like "guinea pigs", ordered the health secretary to monitor all new applications for trials from pharmaceutical companies.

Low costs, weak laws and inadequate enforcement and penalties have made India an attractive destination for the tests, activists say.

The petitioners in the public interest litigation case — a group of doctors and a voluntary organization — claim several patients seeking medical help in the central state of Madhya Pradesh were used in drug tests.

The groups say they have compiled and submitted a report on more than 200 cases in which patients were subjected to trials to check the efficacy of various new treatments without their permission.

Drug trials are an essential step for pharmaceutical companies in order to win regulatory approval to bring new drugs to market.

Earlier this year, 12 doctors were accused of conducting secret trials on children and patients with learning disabilities. They paid fines of less than $100 each.

Faced with mounting criticism, the Indian Council of Medical Research in 2011 sought proposals from doctors and health activists on new draft guidelines for compensation for people used in drug trials.

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Brain image study: Fructose may spur overeating


This is your brain on sugar — for real. Scientists have used imaging tests to show for the first time that fructose, a sugar that saturates the American diet, can trigger brain changes that may lead to overeating.


After drinking a fructose beverage, the brain doesn't register the feeling of being full as it does when simple glucose is consumed, researchers found.


It's a small study and does not prove that fructose or its relative, high-fructose corn syrup, can cause obesity, but experts say it adds evidence they may play a role. These sugars often are added to processed foods and beverages, and consumption has risen dramatically since the 1970s along with obesity. A third of U.S. children and teens and more than two-thirds of adults are obese or overweight.


All sugars are not equal — even though they contain the same amount of calories — because they are metabolized differently in the body. Table sugar is sucrose, which is half fructose, half glucose. High-fructose corn syrup is 55 percent fructose and 45 percent glucose. Some nutrition experts say this sweetener may pose special risks, but others and the industry reject that claim. And doctors say we eat too much sugar in all forms.


For the study, scientists used magnetic resonance imaging, or MRI, scans to track blood flow in the brain in 20 young, normal-weight people before and after they had drinks containing glucose or fructose in two sessions several weeks apart.


Scans showed that drinking glucose "turns off or suppresses the activity of areas of the brain that are critical for reward and desire for food," said one study leader, Yale University endocrinologist Dr. Robert Sherwin. With fructose, "we don't see those changes," he said. "As a result, the desire to eat continues — it isn't turned off."


What's convincing, said Dr. Jonathan Purnell, an endocrinologist at Oregon Health & Science University, is that the imaging results mirrored how hungry the people said they felt, as well as what earlier studies found in animals.


"It implies that fructose, at least with regards to promoting food intake and weight gain, is a bad actor compared to glucose," said Purnell. He wrote a commentary that appears with the federally funded study in Wednesday's Journal of the American Medical Association.


Researchers now are testing obese people to see if they react the same way to fructose and glucose as the normal-weight people in this study did.


What to do? Cook more at home and limit processed foods containing fructose and high-fructose corn syrup, Purnell suggested. "Try to avoid the sugar-sweetened beverages. It doesn't mean you can't ever have them," but control their size and how often they are consumed, he said.


A second study in the journal suggests that only severe obesity carries a high death risk — and that a few extra pounds might even provide a survival advantage. However, independent experts say the methods are too flawed to make those claims.


The study comes from a federal researcher who drew controversy in 2005 with a report that found thin and normal-weight people had a slightly higher risk of death than those who were overweight. Many experts criticized that work, saying the researcher — Katherine Flegal of the Centers for Disease Control and Prevention — painted a misleading picture by including smokers and people with health problems ranging from cancer to heart disease. Those people tend to weigh less and therefore make pudgy people look healthy by comparison.


Flegal's new analysis bolsters her original one, by assessing nearly 100 other studies covering almost 2.9 million people around the world. She again concludes that very obese people had the highest risk of death but that overweight people had a 6 percent lower mortality rate than thinner people. She also concludes that mildly obese people had a death risk similar to that of normal-weight people.


Critics again have focused on her methods. This time, she included people too thin to fit what some consider to be normal weight, which could have taken in people emaciated by cancer or other diseases, as well as smokers with elevated risks of heart disease and cancer.


"Some portion of those thin people are actually sick, and sick people tend to die sooner," said Donald Berry, a biostatistician at the University of Texas MD Anderson Cancer Center in Houston.


The problems created by the study's inclusion of smokers and people with pre-existing illness "cannot be ignored," said Susan Gapstur, vice president of epidemiology for the American Cancer Society.


A third critic, Dr. Walter Willett of the Harvard School of Public Health, was blunter: "This is an even greater pile of rubbish" than the 2005 study, he said. Willett and others have done research since the 2005 study that found higher death risks from being overweight or obese.


Flegal defended her work. She noted that she used standard categories for weight classes. She said statistical adjustments were made for smokers, who were included to give a more real-world sample. She also said study participants were not in hospitals or hospices, making it unlikely that large numbers of sick people skewed the results.


"We still have to learn about obesity, including how best to measure it," Flegal's boss, CDC Director Dr. Thomas Frieden, said in a written statement. "However, it's clear that being obese is not healthy - it increases the risk of diabetes, heart disease, cancer, and many other health problems. Small, sustainable increases in physical activity and improvements in nutrition can lead to significant health improvements."


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Online:


Obesity info: http://www.cdc.gov/obesity/data/trends.html


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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP


Mike Stobbe can be followed at http://twitter.com/MikeStobbe


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At least 61 crushed to death in Ivory Coast stampede


ABIDJAN (Reuters) - At least 61 people were crushed to death in a stampede after a New Year's Eve fireworks display at a stadium in Ivory Coast's main city Abidjan early on Tuesday, officials said.


Witnesses said police had tried to control crowds around the Felix Houphouet-Boigny Stadium following the celebrations, triggering a panic in which scores were trampled.


"The estimate we can give right now is 49 people hospitalized ... and 61 people dead," said the chief of staff of Abidjan's fire department Issa Sacko.


Crying women searched for missing family members outside the stadium on Tuesday morning. The area was covered in patches of dried blood and abandoned shoes.


"My two children came here yesterday. I told them not to come but they didn't listen. They came when I was sleeping. What will I do?" said Assetou Toure, a cleaner.


Sanata Zoure, a market vendor injured in the incident, said New Year's revelers going home after watching the fireworks had been stopped by police near the stadium.


"We were walking with our children and we came upon barricades, and people started falling into each other. We were trampled with our children," she said.


Another witness said police arrived to control the crowd after a mob began chasing a pickpocket.


President Alassane Ouattara called the deaths a national tragedy and said an investigation was under way to find out what happened.


"I hope that we can determine what caused this drama so that we can ensure it never happens again," he said after visiting the injured in hospital.


The country, once a stable economic hub for West Africa, is struggling to recover from a 2011 civil war in which more than 3,000 people were killed.


Ivory Coast's security forces once were among the best trained in the region, but a decade of political turmoil and the 2011 war has left them in disarray.


At least 18 people were killed in another stampede during a football match in an Abidjan stadium in 2009.


(Reporting by Loucoumane Coulibaly and Alain Amontchi; Writing by Richard Valdmanis; Editing by Michael Roddy)



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Tennis: Davis Cup row brews in India






CHENNAI, India: Indian tennis was hit by controversy on Wednesday over reports that top players may boycott next month's Davis Cup tie against South Korea if a slew of demands were not met.

The group of players, headed by Somdev Devvarman, want a better distribution of the Davis Cup prize money, a change in the support staff and involvement in the choice of venues for ties.

The All-India Tennis Association (AITA) and the players currently have a 50-50 share of the prize money sent by the world governing body from revenues earned from the tournament.

The players also wanted non-playing captain Shiv Misra and national coach Nandan Bal to be replaced and a full-time physiotherapist be inducted in the squad.

Both the AITA and Devvarman played down a report in Wednesday's Hindustan Times that the players could stay away from the Cup tie against the Koreans if their demands were ignored.

The Asia-Oceania group one tie in New Delhi from February 1-3 will take the winners into the play-offs for next year's elite world group.

"I don't want to point fingers at anyone or make an alarming statement," said Devvarman, who is taking part in the ongoing ATP Chennai Open.

"You will probably hear more about it in the days to come."

An AITA official, who did not want to be named, accepted the players had made suggestions which will be discussed before the Cup squad is named around January 11.

"It's not as serious an issue as is being made out," the official told AFP. "We have already spoken to the players and will arrive at an agreement soon."

Among those players supporting Devvarman' stance are senior players Mahesh Bhupathi and Rohan Bopanna, but former captain Leander Paes is not part of the group.

Trouble had also erupted ahead of the London Olympics last year when both Bopanna and Bhupathi declined to partner Paes at the Games for what they said were personal and professional reasons.

The controversy started after the AITA initially named the veteran duo of Bhupathi and Paes for the doubles, even though Bhupathi wanted to play with his then partner Bopanna.

The AITA were later forced to pick two doubles teams for the Olympics, with Paes pairing with lower-ranked Vishnu Vardhan, and Bhupathi partnering Bopanna.

Both pairs fell in early rounds at the Games.

Devvarman, who was India's top player with a ranking of 62 in mid-2011, fell to 663 by the end of last year when he was sidelined with a shoulder injury for almost seven months.

The 27-year-old proved he was fit again as he defeated the 106th-ranked Jan Hajek of the Czech Republic in the first round of the Chennai Open on Tuesday.

- AFP/de



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Cold wave hits normal life in Punjab, Haryana

CHANDIGARH: Normal life was thrown out of gear as intense cold conditions prevailed in most parts of Punjab and Haryana with mercury dropping by up to three notches below normal in the two states.

Due to dense fog and mist which resulted in low visibility, rail, road and air traffic remained disrupted as many trains and flights were either rescheduled or cancelled for various destinations.

People will not get any respite from icy winds for the time being as the MeT department in its forecast said cold wave will continue for next 2 to 3 days and maximum temperature will remain well below 16 degrees Celsius in plain areas of Punjab and Haryana.

"Current weather conditions will continue to prevail for next 2-3 days in Punjab and Haryana," Chandigarh MeT Department, Director, Surinder Pal said today.

Fog and mist will also occur during next 24 hours, the MeT Department said.

The MeT Department has also warned of ground frost that may occur at a few places in both states.

Narnaul in Haryana remained the coldest place in plains of both states with minimum at 2.4 deg C, down by three notches below normal.

Bhiwani and Hisar had a low of 3.6 deg C and 4 deg C respectively, while Ambala and Karnal shivered at 5.5 deg C and 5 deg C, down by two notches below normal.

Union Territory of Chandigarh had a low of 4.2 deg C, dipping by a degree below normal.

In Punjab, Amritsar recorded minimum temperature of 7.2 deg C, up by 4 degrees above normal, while Ludhiana and Patiala had a low of 7 deg C and 5.5 deg C respectively.

The maximum temperature in Punjab and Haryana has also observed sharp drop with mercury at most of the places in two states dropping by up to whopping 11 notches below normal.

On Tuesday, Patiala had a maximum of 9.5 deg C, down by 11 degrees below normal. Similarly Chandigarh and Ambala had a maximum of 11.3 deg C and 10.8 deg C.

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Clinton's blood clot an uncommon complication


The kind of blood clot in the skull that doctors say Hillary Rodham Clinton has is relatively uncommon but can occur after an injury like the fall and concussion the secretary of state was diagnosed with earlier this month.


Doctors said Monday that an MRI scan revealed a clot in a vein in the space between the brain and the skull behind Clinton's right ear.


The clot did not lead to a stroke or neurological damage and is being treated with blood thinners, and she will be released once the proper dose is worked out, her doctors said in a statement.


Clinton has been at New York-Presbyterian Hospital since Sunday, when the clot was diagnosed during what the doctors called a routine follow-up exam. At the time, her spokesman would not say where the clot was located, leading to speculation it was another leg clot like the one she suffered behind her right knee in 1998.


Clinton had been diagnosed with a concussion Dec. 13 after a fall in her home that was blamed on a stomach virus that left her weak and dehydrated.


The type of clot she developed, a sinus venous thrombosis, "certainly isn't the most common thing to happen after a concussion" and is one of the few types of blood clots in the skull or head that are treated with blood thinners, said neurologist Dr. Larry Goldstein. He is director of Duke University's stroke center and has no role in Clinton's care or personal knowledge of it.


The area where Clinton's clot developed is "a drainage channel, the equivalent of a big vein inside the skull — it's how the blood gets back to the heart," Goldstein explained.


It should have no long-term consequences if her doctors are saying she has suffered no neurological damage from it, he said.


Dr. Joseph Broderick, chairman of neurology at the University of Cincinnati College of Medicine, also called Clinton's problem "relatively uncommon" after a concussion.


He and Goldstein said the problem often is overdiagnosed. They said scans often show these large "draining pipes" on either side of the head are different sizes, which can mean blood has pooled or can be merely an anatomical difference.


"I'm sure she's got the best doctors in the world looking at her," and if they are saying she has no neurological damage, "I would think it would be a pretty optimistic long-term outcome," Broderick said.


A review article in the New England Journal of Medicine in 2005 describes the condition, which more often occurs in newborns or young people but can occur after a head injury. With modern treatment, more than 80 percent have a good neurologic outcome, the report says.


In the statement, Clinton's doctors said she "is making excellent progress and we are confident she will make a full recovery. She is in good spirits, engaging with her doctors, her family, and her staff."


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Online:


Medical journal: http://dura.stanford.edu/Articles/Stam_NEJM05.pdf


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Senate Approves 'Fiscal Cliff' Deal, Sends to House












Hours past a self-imposed deadline for action, the Senate passed legislation early New Year's Day to neutralize a fiscal cliff combination of across-the-board tax increases and spending cuts that kicked in at midnight. The pre-dawn vote was a lopsided 89-8.



Senate passage set the stage for a final showdown in the House, where a vote was expected later Tuesday or perhaps Wednesday on the measure, which also raises tax rates on wealthy Americans.



Even by the recent dysfunctional standards of government-by-gridlock, the activity at both ends of historic Pennsylvania Avenue was remarkable as the administration and lawmakers spent the final hours of 2012 haggling over long-festering differences.



"It shouldn't have taken this long to come to an agreement, and this shouldn't be the model for how we do things around here," said Senate Republican leader Mitch McConnell, who negotiated the agreement with Vice President Joe Biden.



Shortly after the Senate vote, President Barack Obama said, "While neither Democrats nor Republicans got everything they wanted, this agreement is the right thing to do for our country and the House should pass it without delay."



Under the deal, taxes would remain steady for the middle class and rise at incomes over $400,000 for individuals and $450,000 for couples — levels higher than Obama had campaigned for in his successful drive for a second term in office.





Spending cuts totaling $24 billion over two months aimed at the Pentagon and domestic programs would be deferred. That would allow the White House and lawmakers time to regroup before plunging very quickly into a new round of budget brinkmanship certain to revolve around Republican calls to rein in the cost of Medicare and other government benefit programs.



Officials also decided at the last minute to use the measure to prevent a $900 pay raise for lawmakers due to take effect this spring.



"One thing we can count on with respect to this Congress is that if there's even one second left before you have to do what you're supposed to do, they will use that last second," the president said in a mid-afternoon status update on the talks. Yet when the roll was called nearly 12 hours later, only six Republicans and two Democrats opposed the measure.



As darkness fell on the last day of the year, Obama, Biden and their aides were at work in the White House, and lights burned in the House and Senate. Democrats complained that Obama had given away too much in agreeing to limit tax increases to incomes over $450,000, far above the $250,000 level he campaigned on. Yet some Republicans recoiled at the prospect of raising taxes at all.



Democratic senators said they expected a post-midnight vote on the measure. They spoke after a closed-door session with Vice President Joseph Biden, who brokered the deal with Senate Republican leader Mitch McConnell.



"The argument is that this is the best that can be done on a bipartisan basis," said Sen. Dianne Feinstein, D-Calif., when asked about the case the vice president had delivered behind closed doors.



Passage would send the measure to the House, where Speaker John Boehner, R-Ohio, refrained from endorsing a package as yet unseen by his famously rebellious rank-and-file. He said the House would not vote on any Senate-passed measure "until House members — and the American people — have been able to review" it.





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North Korean leader, in rare address, seeks end to confrontation with South


SEOUL (Reuters) - North Korean leader Kim Jong-un called for an end to confrontation between the two Koreas, technically still at war in the absence of a peace treaty to end their 1950-53 conflict, in a surprise New Year speech broadcast on state media.


The address by Kim, who took over power in the reclusive state after his father, Kim Jong-il, died in 2011, appeared to take the place of the policy-setting New Year editorial published in leading state newspapers.


But North Korea has offered olive branches before and Kim's speech does not necessarily signify a change in tack from a country which vilifies the United States and U.S. ally South Korea at every chance it gets.


Impoverished North Korea raised tensions in the region by launching a long-range rocket in December that it said was aimed at putting a scientific satellite in orbit, drawing international condemnation.


North Korea, which considers North and South as one country, the Democratic People's Republic of Korea, is banned from testing missile or nuclear technology under U.N. sanctions imposed after its 2006 and 2009 nuclear weapons tests.


"An important issue in putting an end to the division of the country and achieving its reunification is to remove confrontation between the north and the south," Kim said in the address that appeared to be pre-recorded and was made at an undisclosed location.


"The past records of inter-Korean relations show that confrontation between fellow countrymen leads to nothing but war."


The New Year address was the first in 19 years by a North Korean leader after the death of Kim Il-sung, Kim Jong-un's grandfather. Kim Jong-il rarely spoke in public and disclosed his national policy agenda in editorials in state newspapers.


"(Kim's statement) apparently contains a message that he has an intention to dispel the current face-off (between the two Koreas), which could eventually be linked with the North's call for aid (from the South)," said Kim Tae-woo, a North Korea expert at the state-funded Korea Institute for National Unification.


"But such a move does not necessarily mean any substantive change in the North Korean regime's policy towards the South."


The two Koreas have seen tensions rise to the highest level in decades after the North bombed a Southern island in 2010 killing two civilians and two soldiers.


The sinking of a South Korean navy ship earlier that year was blamed on the North but Pyongyang has denied it and accused Seoul of waging a smear campaign against its leadership.


Last month, South Korea elected as president Park Geun-hye, a conservative daughter of assassinated military ruler Park Chung-hee whom Kim Il-sung had tried to kill at the height of their Cold War confrontation.


Park has vowed to pursue engagement with the North and called for dialogue to build confidence but has demanded that Pyongyang abandon its nuclear weapons ambitions, something it is unlikely to do.


Conspicuously absent from Kim's speech was any mention of the nuclear arms program.


(Additional reporting by Sung-Won Shim; Editing by Nick Macfie)



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Japan's Sharp considering US$1.15b public offering: report






TOKYO: Embattled Japanese electronics firm Sharp is considering making a public share offering worth more than 100 billion yen ($1.15 billion) early this year, a report said Tuesday.

The public offering could take place in the spring with the firm hoping to use the funds to strengthen its mainstay liquid crystal display (LCD) business and improve its creditworthiness, the Yomiuri Shimbun newspaper said.

Sharp has started talks with major creditor banks and wants to include the capital increase scheme in a mid-term business plan to be announced as early as February, the mass-circulation daily said without naming its sources.

The cash-strapped company said in December it had struck a 9.9-billion-yen capital injection deal with US-based chipmaker Qualcomm as it moves to repair its tattered balance sheet.

The Qualcomm deal will see the pair jointly develop energy-efficient LCD panels for smartphones using the Japanese firm's technology, with the US company initially getting about 2.64 per cent of Sharp's stock.

Japan's battered electronics sector has suffered from a myriad of problems including a high yen, slowing demand in key export markets, fierce overseas competition and strategic mistakes that left its finances in ruins.

Sharp has suffered a series of credit rating downgrades and warned it expects to lose about $5.6 billion in the fiscal year to March 2013.

The Osaka-based maker of Aquos-brand electronics has announced thousands of job losses while cutting wages for employees -- from the factory floor to the boardroom -- and selling real estate to shore up its balance sheet.

Sharp said last year it had reached a capital injection deal worth about $800 million with Taiwan's Hon Hai Precision, which makes Apple gadgets in China, but the deal stalled as Sharp's share price nosedived.

-AFP/ac



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Strengthen legal regime against rape: UN rights chief to India

UNITED NATIONS: Expressing "deep sadness" at the death of the 23-year-old Delhi gang rape victim, UN human rights chief Navi Pillay has asked India to strengthen its legal regime to get rid of the "terrible scourge" of rape.

The UN High Commissioner for Human Rights said rape is a "national problem" in India, affecting women of all classes and castes and requires national solutions.

Pillay expressed deep sadness over the death of Delhi rape victim and said she joined Indians in "all walks of life in condemning" the attack on the student, expressing confidence that India could emerge reformed in the wake of this "terrible crime."

"India has shown through its social reform movements of the past that it can rid itself of a scourge like rape," she said.

She called for an "urgent and rational debate" aimed at ending violence against women in India.

"What is needed is a new public consciousness and more effective and sensitive enforcement of the law in the interests of women," she said.

"Now is the time to strengthen India's legal regime against rape. I encourage the Indian government to consult widely with civil society and to invite the United Nations Special Rapporteur on violence against women to visit the country to assist in this process," she added.

"Let us hope that 2013 will be the year the tide is turned on violence against women in India and all women can walk free without fear," she said.

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