FDA proposes sweeping new food safety rules


WASHINGTON (AP) — The Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens.


The long-overdue regulations could cost businesses close to half a billion dollars a year to implement, but are expected to reduce the estimated 3,000 deaths a year from foodborne illness. Just since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe have been linked to more than 400 illnesses and as many as seven deaths, according to the federal Centers for Disease Control and Prevention. The actual number of those sickened is likely much higher.


The FDA's proposed rules would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean, and that animals stay out of fields. Food manufacturers will have to submit food safety plans to the government to show they are keeping their operations clean.


Many responsible food companies and farmers are already following the steps that the FDA would now require them to take. But officials say the requirements could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.


In a 2011 outbreak of listeria in cantaloupe that claimed 33 lives, for example, FDA inspectors found pools of dirty water on the floor and old, dirty processing equipment at Jensen Farms in Colorado where the cantaloupes were grown. In a peanut butter outbreak this year linked to 42 salmonella illnesses, inspectors found samples of salmonella throughout Sunland Inc.'s peanut processing plant in New Mexico and multiple obvious safety problems, such as birds flying over uncovered trailers of peanuts and employees not washing their hands.


Under the new rules, companies would have to lay out plans for preventing those sorts of problems, monitor their own progress and explain to the FDA how they would correct them.


"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA's deputy commissioner for foods.


The FDA estimates the new rules could prevent almost 2 million illnesses annually, but it could be several years before the rules are actually preventing outbreaks. Taylor said it could take the agency another year to craft the rules after a four-month comment period, and farms would have at least two years to comply — meaning the farm rules are at least three years away from taking effect. Smaller farms would have even longer to comply.


The new rules, which come exactly two years to the day President Barack Obama's signed food safety legislation passed by Congress, were already delayed. The 2011 law required the agency to propose a first installment of the rules a year ago, but the Obama administration held them until after the election. Food safety advocates sued the administration to win their release.


The produce rule would mark the first time the FDA has had real authority to regulate food on farms. In an effort to stave off protests from farmers, the farm rules are tailored to apply only to certain fruits and vegetables that pose the greatest risk, like berries, melons, leafy greens and other foods that are usually eaten raw. A farm that produces green beans that will be canned and cooked, for example, would not be regulated.


Such flexibility, along with the growing realization that outbreaks are bad for business, has brought the produce industry and much of the rest of the food industry on board as Congress and FDA has worked to make food safer.


In a statement Friday, Pamela Bailey, president of the Grocery Manufacturers Association, which represents the country's biggest food companies, said the food safety law "can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal."


The new rules could cost large farms $30,000 a year, according to the FDA. The agency did not break down the costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually.


FDA Commissioner Margaret Hamburg said the success of the rules will also depend on how much money Congress gives the chronically underfunded agency to put them in place. "Resources remain an ongoing concern," she said.


The farm and manufacturing rules are only one part of the food safety law. The bill also authorized more surprise inspections by the FDA and gave the agency additional powers to shut down food facilities. In addition, the law required stricter standards on imported foods. The agency said it will soon propose other overdue rules to ensure that importers verify overseas food is safe and to improve food safety audits overseas.


Food safety advocates frustrated over the last year as the rules stalled praised the proposed action.


"The new law should transform the FDA from an agency that tracks down outbreaks after the fact, to an agency focused on preventing food contamination in the first place," said Caroline Smith DeWaal of the Center for Science in the Public Interest.


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Quadruple Amputee Gets Two New Hands on Life













It's the simplest thing, the grasp of one hand in another. But Lindsay Ess will never see it that way, because her hands once belonged to someone else.


Growing up in Texas and Virginia, Lindsay, 29, was always one of the pretty girls. She went to college, did some modeling and started building a career in fashion, with an eye on producing fashion shows.


Then she lost her hands and feet.


Watch the full show in a special edition of "Nightline," "To Hold Again," TONIGHT at 11:35 p.m. ET on ABC


When she was 24 years old, Lindsay had just graduated from Virginia Commonwealth University's well-regarded fashion program when she developed a blockage in her small intestine from Crohn's Disease. After having surgery to correct the problem, an infection took over and shut down her entire body. To save her life, doctors put her in a medically-induced coma. When she came out of the coma a month later, still in a haze, Lindsay said she knew something was wrong with her hands and feet.


"I would look down and I would see black, almost like a body that had decomposed," she said.


The infection had turned her extremities into dead tissue. Still sedated, Lindsay said she didn't realize what that meant at first.








Quadruple Amputee Undergoes Hand Transplant Surgery Watch Video









After Hand Transplant, Relearning How to Hold Watch Video







"There was a period of time where they didn't tell me that they had to amputate, but somebody from the staff said, 'Oh honey, you know what they are going to do to your hands, right?' That's when I knew," she said.


After having her hands and feet amputated, Lindsay adapted. She learned how to drink from a cup, brush her teeth and even text on her cellphone with her arms, which were amputated just below the elbow.


"The most common questions I get are, 'How do you type,'" she said. "It's just like chicken-pecking."


PHOTOS: Lindsay Ess Gets New Hands


Despite her progress, Lindsay said she faced challenges being independent. Her mother, Judith Aronson, basically moved back into her daughter's life to provide basic care, including bathing, dressing and feeding. Having also lost her feet, Lindsay needed her mother to help put on her prosthetic legs.


"I've accepted the fact that my feet are gone, that's acceptable to me," Lindsay said. "My hands [are] not. It's still not. In my dreams I always have my hands."


Through her amputation recovery, Lindsay discovered a lot of things about herself, including that she felt better emotionally by not focusing on the life that was gone and how much she hated needing so much help but that she also truly depends on it.


"I'm such an independent person," she said. "But I'm also grateful that I have a mother like that, because what could I do?"


Lindsay said she found that her prosthetic arms were a struggle.


"These prosthetics are s---," she said. "I can't do anything with them. I can't do anything behind my head. They are heavy. They are made for men. They are claws, they are not feminine whatsoever."


For the next couple of years, Lindsay exercised diligently as part of the commitment she made to qualify for a hand transplant, which required her to be in shape. But the tough young woman now said she saw her body in a different way now.






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Eleven dead in Damascus gas station blast


AZAZ, Syria (Reuters) - At least 11 people were killed and 40 wounded when a car bomb exploded at a crowded petrol station in the Syrian capital Damascus on Thursday, opposition activists said.


The station was packed with people queuing for fuel that has become increasingly scarce during the country's 21-month-long insurgency aimed at overthrowing President Bashar al-Assad.


The semi-official al-Ikhbariya television station showed footage of 10 burnt bodies and Red Crescent workers searching for victims at the site.


The opposition Revolution Leadership Council in Damascus said the explosion was caused by a booby-trapped car.


There was no immediate indication of who was responsible for the bombing in the Barzeh al-Balad district, whose residents include members of the Sunni Muslim majority and other religious and ethnic minorities.


"The station is usually packed even when it has no fuel," said an opposition activist who did not want to be named. "There are lots of people who sleep there overnight, waiting for early morning fuel consignments."


It was the second time that a petrol station has been hit in Damascus this week. Dozens of people were incinerated in an air strike as they waited for fuel on Wednesday, according to opposition sources.


In northern Syria, rebels were battling to seize an air base in their campaign against the air power that Assad has used to bomb rebel-held towns.


More than 60,000 people have been killed in the uprising and civil war, the United Nations said this week, a much higher death toll than previously thought.


DRAMATIC ADVANCES


After dramatic advances over the second half of 2012, the rebels now hold wide swathes of territory in the north and east, but they cannot protect towns and villages from Assad's helicopters and jets.


Hundreds of rebel fighters were attempting to storm the Taftanaz air base, near the highway that links Syria's two main cities, Aleppo and Damascus.


A rebel fighter speaking from near the Taftanaz base overnight said much of the base was still in loyalist hands but insurgents had managed to destroy a helicopter and a fighter jet on the ground.


The northern rebel Idlib Coordination Committee said the rebels had detonated a car bomb inside the base.


The government's SANA news agency said the base had not fallen and that the military had "strongly confronted an attempt by the terrorists to attack the airport from several axes, inflicting heavy losses among them and destroying their weapons and munitions".


Rami Abdulrahman, head of the opposition-aligned Syrian Observatory for Human Rights which monitors the conflict from Britain, said as many as 800 fighters were involved in the assault, including Islamists from Jabhat al-Nusra, a powerful group that Washington considers terrorists.


Taftanaz is mainly a helicopter base, used for missions to resupply army positions cut off by the rebels, as well as for dropping crude "barrel bombs" on rebel-controlled areas.


Near Minakh, another northern air base that rebels have surrounded, government forces have retaliated by shelling and bombing nearby towns.


NIGHTLY BOMBARDMENTS


In the town of Azaz, where the bombardment has become a near nightly occurrence, shells hit a family house overnight. Zeinab Hammadi said her two wounded daughters, aged 10 and 12, had been rushed across the border to Turkey, one with her brain exposed.


"We were sleeping and it just landed on us in the blink of an eye," she said, weeping as she surveyed the damage.


Family members tried to salvage possessions from the wreckage, men lifting out furniture and children carrying out their belongings in tubs.


"He (Assad) wants revenge against the people," said Abu Hassan, 33, working at a garage near the destroyed house. "What is the fault of the children? Are they the ones fighting?"


Opposition activists said warplanes struck a residential building in another rebel-held northern town, Hayyan, killing at least eight civilians.


Video footage showed men carrying dismembered bodies of children and dozens of people searching for victims in the rubble. The provenance of the video could not be independently confirmed.


In addition to their tenuous grip on the north, the rebels also hold a crescent of suburbs on the edge of Damascus, which have come under bombardment by government forces that control the center of the capital.


On Wednesday, according to opposition activists, dozens of people died in an inferno caused by an air strike on a petrol station in a Damascus suburb where residents were lining up for fuel.


The civil war in Syria has become the longest and bloodiest of the conflicts that rose out of uprisings across the Arab world in the past two years.


Assad's family has ruled for 42 years since his father seized power in a coup. The war pits rebels, mainly from the Sunni Muslim majority, against a government supported by members of Assad's Shi'ite-derived Alawite minority sect and some members of other minorities who fear revenge if he falls.


The West, most Sunni-ruled Arab states and Turkey have called for Assad to step down. He is supported by Russia and Shi'ite Iran.


(Additional reporting by Khaled Yacoub Oweis in Amman and Dominic Evans in Beirut; Writing by Peter Graff; Editing by Ruth Pitchford and Giles Elgood)



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600 Indian guitarists play tribute to gang-rape victim






NEW DELHI: A group of 600 guitarists have paid a musical tribute to an Indian gang-rape victim, playing "Imagine" by John Lennon in a bid to spread "hope, peace and promise" in a country still coming to terms with the violence.

The group assembled at a music festival in the eastern Indian hilltown of Darjeeling on Thursday, nearly three weeks after the brutal rape and murder of a student on a moving bus in New Delhi brought an outpouring of national anger.

"We chose this song because it talks about hope, peace and promise," Sonam Bhutia, tourism secretary of Darjeeling and one of the festival organisers, told AFP by telephone.

"The song is so inspiring. It talks about a universe without any boundaries," Bhutia said of the 1971 Lennon track.

"The tribute was a gesture on our part to show that we are with the victim's family in their hour of unimaginable sorrow."

The scenic town of Darjeeling, in a part of India wedged between Nepal and Bhutan, is famous for its tea.

The savage attack on the woman has triggered countrywide protests with calls for better safety and an overhaul of laws governing crimes against women.

-AFP/fl



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Supreme Court notice to centre on fast-tracking sexual abuse cases

NEW DELHI: The Supreme Court on Friday issued notice to the central government on two PILs seeking fast-tracking of all cases of sexual abuse against women and awarding them compensation.

The court also issued notice on the plea seeking creation of additional courts, improving judicial infrastructure and filling of existing vacancies.

An apex court bench of Justice KS Radhakrishnan and Justice Dipak Misra, however, declined to entertain a plea seeking directions to disqualify elected representatives facing criminal cases.

The court said that it could not pass orders on such a plea and that it would issue notice only on the prayers that concerned the violation of the people's fundamental rights.

The notice is returnable in four weeks. The court issued notice on the petitions that were filed in the wake of the gang-rape and torture of a young women by six men in a moving bus in Delhi.

One of the petitioners is Promila Shanker, a retired Indian Administrative Service officer.

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CDC: 1 in 24 admit nodding off while driving


NEW YORK (AP) — This could give you nightmares: 1 in 24 U.S. adults say they recently fell asleep while driving.


And health officials behind the study think the number is probably higher. That's because some people don't realize it when they nod off for a second or two behind the wheel.


"If I'm on the road, I'd be a little worried about the other drivers," said the study's lead author, Anne Wheaton of the Centers for Disease Control and Prevention.


In the CDC study released Thursday, about 4 percent of U.S. adults said they nodded off or fell asleep at least once while driving in the previous month. Some earlier studies reached a similar conclusion, but the CDC telephone survey of 147,000 adults was far larger. It was conducted in 19 states and the District of Columbia in 2009 and 2010.


CDC researchers found drowsy driving was more common in men, people ages 25 to 34, those who averaged less than six hours of sleep each night, and — for some unexplained reason — Texans.


Wheaton said it's possible the Texas survey sample included larger numbers of sleep-deprived young adults or apnea-suffering overweight people.


Most of the CDC findings are not surprising to those who study this problem.


"A lot of people are getting insufficient sleep," said Dr. Gregory Belenky, director of Washington State University's Sleep and Performance Research Center in Spokane.


The government estimates that about 3 percent of fatal traffic crashes involve drowsy drivers, but other estimates have put that number as high as 33 percent.


Warning signs of drowsy driving: Feeling very tired, not remembering the last mile or two, or drifting onto rumble strips on the side of the road. That signals a driver should get off the road and rest, Wheaton said.


Even a brief moment nodding off can be extremely dangerous, she noted. At 60 mph, a single second translates to speeding along for 88 feet — the length of two school buses.


To prevent drowsy driving, health officials recommend getting 7 to 9 hours of sleep each night, treating any sleep disorders and not drinking alcohol before getting behind the wheel.


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Online:


CDC report: http://www.cdc.gov/mmwr


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Ex-USC Player: Painkiller Injections Caused Heart Attack













Despite stated label risks of possible fatal heart attack, stroke or organ failure, college football players across the country are still being given injections of a powerful painkiller on game days so they can play while injured, an ABC News investigation has found.


The drug, a generic version of Toradol, is recommended for the short-term treatment of post-operative pain in hospitals but has increasingly been used in college and professional sports, and its use is not monitored by the NCAA, the governing body of college sports.


Only two of the country's top football programs, Oklahoma and the University of Nebraska, reported to ABC News that they have limited or stopped the use of the drug in the wake of growing concern about its risks.


Which Top-Ranked College Football Teams Use Toradol?


Oklahoma said it stopped using the painkillers in 2012 after using them repeatedly in 2010 and 2011.


Nebraska said its doctors now restrict its use.


SEND TIPS About Painkiller Use in College Sports to Our Tipline


"While team physicians reserve the option to use injectable Toradol, it is rarely prescribed, and its use has been avoided this season following reports of heightened concern of potential adverse effects," Nebraska said in a statement to ABC News.






Stephen Dunn/Getty Images











Despite Risks, College Football Still Uses Powerful Painkiller Watch Video





The top two college football programs, Notre Dame and Alabama, refused to answer questions from ABC News about the painkiller. They play for the national college championship on Jan. 7.


Controversy surrounding the drug has grown this year following claims by former USC lineman Armond Armstead that he suffered a heart attack after the 2010 season, at age 20, following shots of generic Toradol administered over the course of the season by the team doctor and USC personnel.


"I thought, you know, can't be me, you know? This doesn't happen to kids like me," Armstead told ABC News.


The manufacturers' warning label for generic Toradol (ketorolac tromethamine) says the drug is not intended for prolonged periods or for chronic pain and cites gastrointestinal bleeding and kidney failure as possible side effects of the drug.


In addition, like other drugs in its class, the generic Toradol label warns "may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (heart attack), and stroke, which can be fatal."


"This risk may increase with duration of use," the so-called black box warning reads.


In a lawsuit against the school and the doctor, Dr. James Tibone, Armstead claims the school ignored the stated risks of the drug and never told him about them.


"He was a race horse, a prize race horse that needed to be on that field no matter what," said Armstead's mother Christa. "Whether that was a risk to him or not."


Armstead says he and many other USC players would receive injections of what was known only as "the shot" in a specific training room before big games and again at half-time.


"No discussion, just go in. He would give the shot and I would be on my way," Armstead told ABC News.


Armstead said the shot made him feel "super human" despite severe ankle, and later shoulder pain, and that without it, he never could have played in big USC games against Notre Dame and UCLA.


"You can't feel any pain, you just feel amazing," the former star player said.


USC declined to comment on Armstead's claims, or the use of Toradol to treat Trojan players.


An ABC News crew and reporter were ordered off the practice field when they tried to question USC coach Lane Kiffin about the use of the painkiller. USC says the ABC News crew was told to leave because they had not submitted the appropriate paperwork in advance to attend the practice session.






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Central African Republic rebels halt advance, agree to peace talks


DAMARA, Central African Republic (Reuters) - Rebels in Central African Republic said they had halted their advance on the capital on Wednesday and agreed to start peace talks, averting a clash with regionally backed troops.


The Seleka rebels had pushed to within striking distance of Bangui after a three-week onslaught and threatened to oust President Francois Bozize, accusing him of reneging on a previous peace deal and cracking down on dissidents.


Their announcement on Wednesday gave the leader only a limited reprieve as the fighters told Reuters they might insist on his removal in the negotiations.


"I have asked our forces not to move their positions starting today because we want to enter talks in (Gabon's capital) Libreville for a political solution," said Seleka spokesman Eric Massi, speaking by telephone from Paris.


"I am in discussion with our partners to come up with proposals to end the crisis, but one solution could be a political transition that excludes Bozize," he said.


Bozize on Wednesday sacked his Army Chief of Staff and took over the defense minister's role from his son, Jean Francis Bozize, according to a decree read on national radio, a day after publicly criticizing the military for failing to repel the rebels.


The advance by Seleka, an alliance of mostly northeastern rebel groups, was the latest in a series of revolts in a country at the heart of one of Africa's most turbulent regions - and the most serious since the Chad-backed insurgency that swept Bozize to power in 2003.


Diplomatic sources have said talks organized by central African regional bloc ECCAS could start on January 10. The United States, the European Union and France have called on both sides to negotiate and spare civilians.


Central African Republic is one of the least developed countries in the world despite its deposits of gold, diamonds and other minerals. French nuclear energy group Areva mines the country's Bakouma uranium deposit - France's biggest commercial interest in its former colony.


RELIEF IN BANGUI


News of the rebel halt eased tension in Bangui, where residents had been stockpiling food and water and staying indoors after dark.


"They say they are no longer going to attack Bangui, and that's great news for us," said Jaqueline Loza in the crumbling riverside city.


ECCAS members Chad, Congo Republic, Gabon and Cameroon have sent hundreds of soldiers to reinforce CAR's army after a string of rebel victories since early December.


Gabonese General Jean Felix Akaga, commander of the regional force, said his troops were defending the town of Damara, 75 km (45 miles) north of Bangui and close to the rebel front.


"Damara is a red line not to be crossed ... Damara is in our control and Bangui is secure," he told Reuters. "If the rebellion decides to approach Damara, they know they will encounter a force that will react."


Soldiers armed with Kalashnikovs, rocket propelled grenade launchers and truck-mounted machineguns had taken up positions across the town, which was otherwise nearly-abandoned.


Some of the fighters wore turbans that covered their faces and had charms strung around their necks and arms meant to protect them against enemy bullets.


Chad's President Idriss Deby, one of Bozize's closest allies, had warned the rebels the regional force would confront them if they approached the town.


Chad provided training and equipment to the rebellion that brought Bozize to power by ousting then-president Ange Felix Patasse, who Chad accused of supporting Chadian dissidents.


Chad is also keen to keep a lid on instability in the territory close to its main oil export pipeline and has stepped in to defend Bozize against insurgents in the past.


A CAR government minister told Reuters the foreign troop presence strengthened Bozize's bargaining position ahead of the Libreville peace talks.


"The rebels are now in a position of weakness," the minister said, asking not to be named. "They should therefore stop imposing conditions like the departure of the president."


Central African Republic is one of a number of countries in the region where U.S. Special Forces are helping local soldiers track down the Lord's Resistance Army, a rebel group which has killed thousands of civilians across four nations.


France has a 600-strong force in CAR to defend about 1,200 of its citizens who live there.


Paris used air strikes to defend Bozize against a rebellion in 2006. But French President Francois Hollande turned down a request for more help, saying the days of intervening in other countries' affairs were over.


(Additional reporting by Paul-Marin Ngoupana in Bangui and Jon Herskovitz in Johannesburg; Writing by Richard Valdmanis; Editing by Andrew Heavens and Janet Lawrence)



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Starbucks to open first store in Vietnam






HANOI: Starbucks said on Thursday it would open its first store next month in Vietnam, seeking a foothold in the coffee-loving country as part of efforts to expand in Asia.

The country's first Starbucks cafe will be in southern Ho Chi Minh City, the US beverage giant said in a joint statement with its local partner, Hong Kong's Maxim Group.

"Vietnam is one of the most dynamic and exciting markets in the world and we are proud to add Vietnam as the 12th market across the China and Asia-Pacific region," said Starbucks China and Asia Pacific president John Culver.

Starbucks has been targeting growth outside of the stagnant US market, opening thousands of stores in China and across the Asia-Pacific region over the past few years.

In October, it opened its first stores in India, in partnership with domestic giant Tata Global Beverages.

Unlike tea-drinking India, Vietnam - the world's second-largest coffee producer - already has a strong local coffee culture with dozens of popular local chains and small coffee-shops on nearly every street corner.

"Starbucks is deeply respectful of Vietnam's long and distinctive local coffee culture," Culver said in the statement.

"We know coffee is a national pride for many Vietnamese and as such, we look forward to contributing and growing Vietnam's already vibrant coffee industry," he added.

Starbucks already purchases "notable" amounts of high-quality arabica coffee from Vietnam and is committed to buying more over the long-term, according to the statement.

Culver said in December that Starbucks will have almost 4,000 stores in the Asia-Pacific region by the end of 2013, including 1,000 in China.

- AFP/de



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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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