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."

Read More..

Vice President Maduro back in Venezuela, no news on ailing Chavez

CARACAS (Reuters) - Vice President Nicolas Maduro returned to Venezuela on Thursday after visiting Hugo Chavez in hospital in Cuba, but gave no new details on the cancer-stricken president as rumors grow about his condition.

Flanked by senior government figures including Diosdado Cabello, the head of the National Assembly, Maduro toured a coffee production plant in Caracas - the type of visit that the president made frequently before he fell ill.

Chavez, 58, has not been seen in public nor heard from in more than three weeks and officials say the socialist leader is in delicate condition after suffering complications following his fourth cancer operation in just 18 months. But they have offered very few details.

"In the last few hours we were with President Hugo Chavez, bringing him the encouragement and strength of the Venezuelan people," Maduro said on Thursday. He said Cabello, Oil Minister Rafael Ramirez and Chavez's elder brother Adan, among others, had all been with the president in the Cuban hospital.

Venezuelan bonds rallied to 2008 highs on Thursday on rumors about Chavez's health.

In scenes that recalled Chavez's hours-long televised visits to building sites, hospitals and oil refineries, Maduro told workers at the nationalized Fama de America factory that there was no "transition" taking place in the country.

"The only transition in Venezuela is the transition to socialism," he said in comments carried live by state television.

"It began six years ago, ordered by Comandante Hugo Chavez as chief and president, elected, re-elected and ratified, much as it pains the bourgeois hucksters and the right, who have done so much damage to our fatherland."

Chavez's abrupt exit from the political scene would be a huge shock for the South American OPEC nation. His oil-financed socialism has made him a hero to the poor majority but critics call him a dictator.

He is still set to be sworn in on January 10, as spelled out in the constitution. If he were to die or had to step aside, new elections would be held within 30 days, with Maduro running as the ruling Socialist Party candidate.

Chavez's condition is being watched closely by Latin American allies that have benefited from his generous assistance, as well as Wall Street investors who are attracted to Venezuela's lucrative and widely traded debt.

Last year, Chavez staged what appeared to be remarkable comeback from the disease to win re-election to a new six-year term in October despite being weakened by radiation therapy. But he returned to Cuba for more treatment within weeks of his win.

Officials have said he suffered unexpected bleeding and then a respiratory infection after a six-hour operation on December 11.

Top Socialist Party officials have suggested that his inauguration could be postponed indefinitely to accommodate his recovery.

The opposition has insisted that the government should stick to the January 10 date, and on Thursday one opposition leader said they should form an official commission to visit Cuba and assess the president's condition for themselves.

(Editing by Kieran Murray and Lisa Shumaker)

Read More..

Australian soy milk action widened to Japanese firms

SYDNEY: Hundreds of Australians who became sick after drinking soy milk containing dangerously high levels of iodine have widened their class action to include two Japanese companies, lawyers said.

About 600 Australians became ill after consuming Bonsoy milk, many suffering thyroid problems, up until the product was withdrawn from sale in late 2009, Maurice Blackburn Lawyers said late Thursday.

The case against the Australian brand owner Spiral Foods launched in the Victorian Supreme Court in 2010 had been widened to include manufacturer Marusan-ai Co Ltd and exporter Muso Co Ltd, the firm said.

"We say that these three companies had test results in mid-2006 which showed that Bonsoy contained extremely high levels of iodine, but they did nothing," said senior associate Irina Lubomirska in a statement.

Lubomirska said the companies had breached consumer protection laws in Australia and Japan.

"None of the three companies did anything to ensure that Bonsoy, which was marketed and sold as a premium health-food soy brand, was in fact safe to consume," she said.

The class action alleges that Spiral requested a reformulation of Bonsoy to include iodine-rich kombu instead of adding salt and that as a result the product had contained excessive iodine since mid-2003.

It also alleges that consumer concerns about iodine were repeatedly dismissed.

Victims are seeking compensation for medical expenses and loss of income as well as for the pain and suffering.

By the time Bonsoy was recalled in late 2009, after Australian authorities discovered that one glass contained seven times the upper safe dose of iodine for adults, it had been on the market for six years, Maurice Blackburn said.

Because it was touted as a healthy product, some consumers had increased their intake when they became ill, Lubomirska added.

A directions hearing on the matter is scheduled for March 8.

-AFP/ac

Read More..

1 pilot, 3 airhostesses found drunk since Christmas

NEW DELHI: The fear of losing their flying licence led to pilots celebrating Yuletide and ushering in the New Year on a sober note this year. Authorities caught only one pilot — but three airhostesses — reporting to work in an inebriated state during breathalyser (BA) tests done at airports from Christmas to Wednesday.

All four flight personnel were from Jet Airways. "We have a zero tolerance policy for this issue and carry out strict BA tests. Whoever fails the tests is, as per DGCA guidelines, suspended for three months," said aJet spokesperson.

A DGCA official said two flight crew members failed the BA test in Chennai and one each in Delhi and Kochi. "The punishment is very severe now for pilots failing BA tests as their licence is suspended for three months when caught first time and for five years for the second time. This means end of flying career as a five-year suspension will lead to all eligibilities lapsing," he added.

Read More..

James Holmes Defense: Was He Insane?

Jan 3, 2013 5:30pm

James Holmes appears in court, Centennial, Colo., July 23, 2012. RJ Sangosti/AP Images.

ABC’s Clayton Sandell and Carol McKinley report:

A judge ruled Thursday that public defenders for accused Colorado theater shooting suspect James Holmes can call two unidentified witnesses at next week’s preliminary hearing to testify about the defendant’s “mental state.”

Arapahoe County, Colo. prosecutors had sought to keep the witnesses out of court, but Judge William Sylvester ruled that the now-25-year-old accused killer has a right to call the witnesses at a preliminary hearing.

The Jan. 7 preliminary hearing will essentially be a mini-trial in which prosecutors will present witness testimony and evidence to convince the judge that there is enough of a case against Holmes to proceed to a trial.

Witnesses to be called for the prosecution include the Aurora police lead detective, first responders, the Arapahoe County coroner and likely a computer forensic specialist, according to prosecution sources who declined to be identified, citing a gag order in the case.

A top priority, the prosecution sources say, will be showing that Holmes acted with premeditation when he allegedly murdered 12 people and wounded 58 on the night of July 20 during a midnight showing of “The Dark Knight Rises.”

Defense attorneys may pursue a legal strategy to show that Holmes was not in his right mind at the time of the shooting.

Holmes, who has not yet entered a plea, has been repeatedly described in court by his legal team as mentally ill. While a graduate student at the University of Colorado, he was in the care of a psychiatrist.

Prosecutors say they will also present photos, video and 911 calls during the hearing, which is expected to last all week.

It’s not clear what the two witnesses’ relationship is to the shooting, or to Holmes.

Prosecutors, Judge Sylvester’s order says, contend that “neither witness has personal knowledge of the events at the Century Aurora 16 Theater.”

Sylvester said the witnesses are non-expert “lay witnesses” who have so far chosen not to be interviewed by defense investigators but have been cooperating with law enforcement.

SHOWS: World News

Read More..

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 forecast, 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.

Read More..

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)

Read More..

Clinton out of hospital, keen to resume work

NEW YORK: US Secretary of State Hillary Clinton was released from a New York hospital late Wednesday and is expected to make a full recovery from a rare blood clot in her head, a top aide said.

"Secretary Clinton was discharged from the hospital this evening," Deputy Assistant Secretary Philippe Reines said in a statement, three days after the 65-year-old diplomat was admitted for treatment.

"Her medical team advised her that she is making good progress on all fronts, and they are confident she will make a full recovery," he said, adding that Clinton was "eager to get back to the office."

Earlier the top US diplomat, bundled up against the cold in a winter coat and wearing dark glasses, appeared in public for the first time in almost a month, when she came out of a building at the New York Presbyterian Hospital.

It was the first time Clinton had been seen since catching a stomach virus on returning from a trip to Europe on December 7, which triggered a series of health scares and forced her to cancel a planned visit to North Africa.

Accompanied by her smiling husband, former president Bill Clinton, as well as her daughter Chelsea and several aides, Clinton walked unaided to a waiting black van at the hospital, according to images broadcast by CNN.

Both Clinton and her family "would like to express their appreciation for the excellent care she received from the doctors, nurses and staff at New York Presbyterian Hospital Columbia University Medical Center," Reines added.

He did not say when the secretary would return to work though, promising only to issue an update in the coming days. She is due to step down after four years in office later this month, handing the baton to Senator John Kerry, who has been nominated by President Barack Obama to replace her.

"Grateful my Mom discharged from the hospital & is heading home. Even more grateful her medical team confident she'll make a full recovery," Chelsea Clinton said in a tweet.

Kerry's appointment will have to be confirmed by the new Senate, due to be sworn in on Thursday, but as a veteran, well-respected senator he is expected to sail through the hearing.

Earlier, State Department spokeswoman Victoria Nuland said Clinton had been busy keeping in touch by telephone.

"She has been talking to her staff, including today. She's been quite active on the phone with all of us," Nuland told journalists.

The globe-trotting diplomat was admitted to the hospital on Sunday after a routine scan revealed the clot in a vein behind her right ear in the space between her skull and her brain.

Her doctors Lisa Bardack, from the Mount Kisco Medical Group, and Gigi El-Bayoumi, of George Washington University, said in a statement on Monday that Clinton had not suffered a stroke or any neurological damage.

They said however they would be treating Clinton with blood thinners to break up the clot, which if left untreated could be potentially dangerous.

The effects of the stomach bug caused her to become dehydrated. She then fainted and suffered a concussion, which is thought to have brought on the blood clot.

Clinton still has some unfinished business as she wraps up her popular tenure at the State Department, and is widely expected to testify before the end of the month on the September 11 attack on a diplomatic mission in Libya.

She had been due to appear at hearings last month, after a State Department inquiry found security at the Benghazi mission was "grossly inadequate" but was forced to cancel after she fell ill. Four Americans died in the attack.

Republican Representative Peter King said he believed she still needed to testify "and I think she will be pleased to do it. I never have known Hillary Clinton to back away from a fight."

But King told CNN she should not appear before Congress "until she is absolutely in perfect health."

-AFP/ac

Read More..

2 months on, victim gets rapist cousin arrested

REWARI: Nearly two months after she was raped and shot at by her cousin, a 19-year-old girl mustered enough courage to revealed the incident to police in Rewari on Wednesday. The cops registered a case and arrested accused Deepak Kumar, 23, a college student, immediately.

Rewari SSP Bharti Arora said that the girl, a second year college student, was accompanying her cousin in his car when he raped her on November 3. The victim told cops that when she tried to escape from the car, Deepak opened fire on her and threatened her with dire consequences.

A bullet hit her on the shoulder and she was admitted in a private hospital, where she remained for about a month.

Sources said that since the accused was a close relative, the family too kept the incident under wraps fearing social stigma. But the girl finally revealed her trauma to the Rewari SSP on Wednesday.

The SSP said that the police have registered a case under sections 376 (rape), 307 (attempt to murder) and 506 (criminal intimidation) against the accused.

Read More..

Tax Deal Done - but Where's Obama to Sign It?

Jan 2, 2013 6:29pm

AP Photo/Charles Dharapak

Congress officially delivered the bill to avert the fiscal cliff to the White House this afternoon, House Speaker John Boehner’s office told ABC News.

Now the question is when will the President sign it?

The bill, passed late on New Year’s Day, expires tomorrow at 11:59 a.m. when the current session of Congress concludes. If President Obama doesn’t sign it by then, constitutionally the bill is dead.

But this evening, eighteen hours before the deadline, the President is on a golf course in Hawaii.  And the bill is in Washington at the White House.

Administration officials won’t say what they will do despite repeated inquiries from ABC News.

There seem to be two options:  1) An Air Force jet can deliver the bill to Hawaii (better leave quickly!) in time for the President to sign it before 11:59 Eastern Standard Time; or, 2) The White House can use a presidential “auto-pen.”

The simple mechanical device uses a template of the presidential signature to scrawl it on paper if activated by the White House at Obama’s direction.

But would an auto-pen – usually used to sign insignificant correspondence and photographs – pass constitutional muster?  We don’t know.  The question has never been tested by the courts.

A 2005 legal study commissioned by former President George W. Bush determined that use of the autopen is constitutional but acknowledged the possibility that its use could be challenged.  Bush never used the autopen, officials from his administration told ABC.

President Obama is only believed to have used the autopen once to sign a piece of major legislation — the 2011 extension of the Patriot Act — which reached his desk while he was on a diplomatic trip to Europe. Officials invoked national security concerns to justify the move.

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.” More HERE.

ABC News’ Ann Compton and Devin Dwyer contributed reporting.

SHOWS: World News

Read More..