Indian court to rule on generic drug industry

NEW DELHI (AP) — From Africa's crowded AIDS clinics to the malarial jungles of Southeast Asia, the lives of millions of ill people in the developing world are hanging in the balance ahead of a legal ruling that will determine whether India's drug companies can continue to provide cheap versions of many life-saving medicines.

The case — involving Swiss drug maker Novartis AG's cancer drug Glivec — pits aid groups that argue India plays a vital role as the pharmacy to the poor against drug companies that insist they need strong patents to make drug development profitable. A ruling by India's Supreme Court is expected in early 2013.

"The implications of this case reach far beyond India, and far beyond this particular cancer drug," said Leena Menghaney, from the aid group Doctors Without Borders. "Across the world, there is a heavy dependence on India to supply affordable versions of expensive patented medicines."

With no costs for developing new drugs or conducting expensive trials, India's $26 billion generics industry is able to sell medicine for as little as one-tenth the price of the companies that developed them, making India the second-largest source of medicines distributed by UNICEF in its global programs.

Indian pharmaceutical companies such as Cipla, Cadila Laboratories and Lupin have emerged over the past decade as major sources of generic cancer, malaria, tuberculosis and AIDS drugs for poor countries that can't afford to pay Western prices.

The 6-year-old case that just wrapped up in the Supreme Court revolves around a legal provision in India's 2005 patent law that is aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines — a practice known as "evergreening."

Novartis' argued that a new version of Glivec — marketed in the U.S. as Gleevec — was a significant change from the earlier version because it was more easily absorbed by the body.

India's Patent Controller turned down the application, saying the change was an obvious development, and the new medicine was not sufficiently distinct from the earlier version to warrant a patent extension.

Patient advocacy groups hailed the decision as a blow to "evergreening."

But Western companies argued that India's generic manufacturers were cutting the incentive for major drug makers to invest in research and innovation if they were not going to be able to reap the exclusive profits that patents bring.

"This case is about safeguarding incentives for better medicines so that patients' needs will be met in the future," says Eric Althoff, a Novartis spokesman.

International drug companies have accused India of disregarding intellectual property rights, and have pushed for stronger patent protection that would weaken India's generics industry.

Earlier this year, an Indian manufacturer was allowed to produce a far cheaper version of the kidney and liver cancer treatment sorefinib, manufactured by Bayer Corp.

Bayer was selling the drug for about $5,600 a month. Natco, the Indian company, said its generic version would cost $175 a month, less than 1/30th as much. Natco was ordered to pay 6 percent in royalties to Bayer.

Novartis says the outcome of the new case will not affect the availability of generic versions of Glivec because it is covered by a grandfather clause in India's patent law. Only the more easily absorbed drug would be affected, Althoff said, adding that its own generic business, Sandoz, produces cheap versions of its drugs for millions across the globe.

Public health activists say the question goes beyond Glivec to whether drug companies should get special protection for minor tweaks to medicines that others could easily have uncovered.

"We're looking to the Supreme Court to tell Novartis it won't open the floodgates and allow abusive patenting practices," said Eldred Tellis, of the Sankalp Rehabilitation Centre, a private group working with HIV patients.

The court's decision is expected to be a landmark that will influence future drug accessibility and price across the developing world.

"We're already paying very high prices for some of the new drugs that are patented in India," said Petros Isaakidis, an epidemiologist with Doctors Without Borders. "If Novartis' wins, even older medicines could be subject to patenting again, and it will become much more difficult for us in future to provide medicines to our patients being treated for HIV, hepatitis and drug resistant TB."

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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.

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"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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NYP students to run on-campus restaurant

SINGAPORE: Students of Nanyang Polytechnic (NYP) will get to run a restaurant on campus from April, as part of their final-year studies.

The exposure will give them an idea of what they can expect in the food and beverage industry.

The students, who are now honing their skills in the kitchen of the polytechnic, will take on bigger challenges when the restaurant is up and running.

They will be in charge of every aspect of the business - from designing the menu to managing the earnings.

The restaurant, which can seat 120, will serve fusion cuisine created by the students and their lecturers.

"I hope they treat the new training restaurant like it's their first job. I'll need to train them but they need to learn speed, they need to learn efficiency, they need to learn style. Those three things," said senior lecturer Andy Gibb.

"If they can treat it as their first job without getting any money in their back pockets, when they finish training in the restaurant, they will go a very very long way."

- CNA/xq

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Mamata, Manmohan exchange pleasantries in first meeting after FDI standoff

KOLKATA: West Bengal chief minister Mamata Banerjee and Prime Minister Manmohan Singh shared the stage at the centenary session of the 100^th Science Congress at Salt Lake stadium on Thursday morning. This was their first meeting a little over three months after the Trinamool Congress dumped the UPA over the FDI in multi brand retail.

The chief minister went and sat beside Singh and the two were smiling as they spoke in between speeches at the congress where nearly 15,000 scientists are expected to participate. The Trinamool Congress' six ministers submitted their resignations to the Prime Minister on September 21 signaling the end of a strained relationship between the Congress and the Trinamool Congress.

The body language from both sides was positive. Also present on the dais was President Pranab Mukherjee. He inaugurated the five-day meet where several foreign delegates, Nobel laureates and Indian scientists were present.

The Prime Minister unveiled the country's science, technology and innovation policy that aims to put India among the top five science powerhouses in the world by 2020.

Singh welcomed a debate on genetically modified foods, nuclear energy and space exploration. He said, "The transformation of agriculture must be the top priority of our public policies, including science and technology policies. We must partner not only with established leaders in science and technology but with emerging innovation powerhouses in our region."

Singh said science should be used to meet the needs of the underprivileged.

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Flu? Malaria? Disease forecasters look to the sky

NEW YORK (AP) — Only a 10 percent chance of showers today, but a 70 percent chance of flu next month.

That's the kind of forecasting health scientists are trying to move toward, as they increasingly include weather data in their attempts to predict disease outbreaks.

In one recent study, two scientists reported they could predict — more than seven weeks in advance — when flu season was going to peak in New York City. Theirs was just the latest in a growing wave of computer models that factor in rainfall, temperature or other weather conditions to forecast disease.

Health officials are excited by this kind of work and the idea that it could be used to fine-tune vaccination campaigns or other disease prevention efforts.

At the same time, experts note that outbreaks are influenced as much, or more, by human behavior and other factors as by the weather. Some argue weather-based outbreak predictions still have a long way to go. And when government health officials warned in early December that flu season seemed to be off to an early start, they said there was no evidence it was driven by the weather.

This disease-forecasting concept is not new: Scientists have been working on mathematical models to predict outbreaks for decades and have long factored in the weather. They have known, for example, that temperature and rainfall affect the breeding of mosquitoes that carry malaria, West Nile virus and other dangerous diseases.

Recent improvements in weather-tracking have helped, including satellite technology and more sophisticated computer data processing.

As a result, "in the last five years or so, there's been quite an improvement and acceleration" in weather-focused disease modeling, said Ira Longini, a University of Florida biostatistician who's worked on outbreak prediction projects.

Some models have been labeled successes.

In the United States, researchers at Johns Hopkins University and the University of New Mexico tried to predict outbreaks of hantavirus in the late 1990s. They used rain and snow data and other information to study patterns of plant growth that attract rodents. People catch the disease from the droppings of infected rodents.

"We predicted what would happen later that year," said Gregory Glass, a Johns Hopkins researcher who worked on the project.

More recently, in east Africa, satellites have been used to predict rainfall by measuring sea-surface temperatures and cloud density. That's been used to generate "risk maps" for Rift Valley fever — a virus that spreads from animals to people and in severe cases can cause blindness or death. Researchers have said the system in some cases has given two to six weeks advance warning.

Last year, other researchers using satellite data in east Africa said they found that a small change in average temperature was a warning sign cholera cases would double within four months.

"We are getting very close to developing a viable forecasting system" against cholera that can help health officials in African countries ramp up emergency vaccinations and other efforts, said a statement by one of the authors, Rita Reyburn of the International Vaccine Institute in Seoul, South Korea.

Some diseases are hard to forecast, such as West Nile virus. Last year, the U.S. suffered one of its worst years since the virus arrived in 1999. There were more than 2,600 serious illnesses and nearly 240 deaths.

Officials said the mild winter, early spring and very hot summer helped spur mosquito breeding and the spread of the virus. But the danger wasn't spread uniformly. In Texas, the Dallas area was particularly hard-hit, while other places, including some with similar weather patterns and the same type of mosquitoes, were not as affected.

"Why Dallas, and not areas with similar ecological conditions? We don't really know," said Roger Nasci of the Centers for Disease Control and Prevention. He is chief of the CDC branch that tracks insect-borne viruses.

Some think flu lends itself to outbreak forecasting — there's already a predictability to the annual winter flu season. But that's been tricky, too.

Seasonal flu reports come from doctors' offices, but those show the disease when it's already spreading. Some researchers have studied tweets on Twitter and searches on Google, but their work has offered a jump of only a week or two on traditional methods.

In the study of New York City flu cases published last month in the Proceedings of the National Academy of Sciences, the authors said they could foredcast, by up to seven weeks, the peak of flu season.

They designed a model based on weather and flu data from past years, 2003-09. In part, their design was based on earlier studies that found flu virus spreads better when the air is dry and turns colder. They made calculations based on humidity readings and on Google Flu Trends, which tracks how many people are searching each day for information on flu-related topics (often because they're beginning to feel ill).

Using that model, they hope to try real-time predictions as early as next year, said Jeffrey Shaman of Columbia University, who led the work.

"It's certainly exciting," said Lyn Finelli, the CDC's flu surveillance chief. She said the CDC supports Shaman's work, but agency officials are eager to see follow-up studies showing the model can predict flu trends in places different from New York, like Miami.

Despite the optimism by some, Dr. Edward Ryan, a Harvard University professor of immunology and infectious diseases, is cautious about weather-based prediction models. "I'm not sure any of them are ready for prime time," he said.

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Obama Signs 'Fiscal Cliff' Bill With Autopen

Jan 3, 2013 12:53am

Charles Dharapak/AP Photo

HONOLULU, Hawaii — President Obama has signed the “fiscal cliff” legislation into law via autopen from Hawaii, where he is vacationing with his family.

The bill to avert the “fiscal cliff” arrived at the White House late this afternoon and it was immediately processed, according to a senior White House official. A copy was delivered to the president in Hawaii for review. He then directed the bill to be signed by autopen back in Washington, D.C.

The Bush administration deemed in 2005 that the use of the autopen is constitutional, although President George W. Bush never used the mechanical device to replicate his signature on a bill.

The office of legal counsel found at the time that Article 1, Section 7 of the Constitution allows the president to use the autopen to sign legislation, stating “the President need not personally perform the physical act of affixing his signature to a bill to sign it.”

Obama has used the autopen twice in the past to sign legislation, both times while he was overseas.

Use of the autopen has been controversial.  Conservative groups alleged last summer that Obama used an autopen to sign condolence letters to the families of Navy SEALs killed in a Chinook crash in Afghanistan — a charge the White House disputed flatly as false.

In 2004, then-Secretary of Defense Donald Rumsfeld was criticized for using an autopen to sign condolence letters to the families of fallen troops.

And in 1992 then-Vice President Dan Quayle even got into some hot water over his use of the autopen on official correspondence during an appearance on “This Week with David Brinkley.”

Obama, who arrived back in Hawaii early Wednesday morning to continue his family vacation, spent the afternoon golfing with friends at the Marine Corps base at Kaneohe Bay.

Obama is slated to remain in Hawaii through Saturday.

ABC News’ Jonathan Karl contributed to this report

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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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US, Europe 'biggest risks' for global economy in 2013, says Nobel laureate

FRANKFURT: Debt problems in both the United States and Europe represent the biggest risks for the global economy in 2013, Nobel prize laureate Joseph Stiglitz wrote in a newspaper article on Wednesday.

"In the outlook for 2013, the biggest risks for the global economy are in the US and in Europe," Stiglitz wrote in a guest column for the business daily Handelsblatt.

But "the real risk for the global economy lies in Europe," he warned.

"Spain and Greece are in an economic depression with no hope for a recovery. The eurozone's 'fiscal pact' is no solution, and the European Central Bank's bond purchase is a temporary palliative, at best," Stiglitz wrote.

And the ECB must not impose further conditions for financial aid to countries, he continued.

"Otherwise, the medicine will lead to a deterioration in the patient's condition," Stiglitz argued.

- AFP/de

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Will implement SC judgement on Lokayukta soon: Gujarat govt

GANDHINAGAR: With the Supreme Court today upholding governor Kamla Beniwal's decision to appoint Justice (retd) R A Mehta as Gujarat Lokayukta, the Narendra Modi government said it would soon implement the apex court judgement.

"We will soon implement the Supreme Court judgement on Lokayukta," state law minister Bhupindersinh Chudasama said.

"The Supreme Court has accepted Gujarat government's contention that governor has to act as per the advice of the council of ministers," he added.

A detailed reaction on the issue could only be given after reading the judgement, Chudasama said.

In a setback to the Gujarat government, the Supreme Court upheld Mehta's appointment as the state Lokayukta, saying it was done in consultation with the Chief Justice of Gujarat HC.

The governor was bound to act under advice of council of ministers, but in this case the appointment was not wrong since it was done in consultation with the high court Chief Justice, the apex court said.

Governor Kamla Beniwal had on August 25 last year appointed Justice Mehta to the post of Lokayukta, which had been lying vacant for the last eight years.

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