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Colombia Threatens to End Patent Protection for Novartis Cancer Drug Over Price

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Colombia Threatens to End Patent Protection for Novartis Cancer Drug Over Price

If the pharma giant doesn’t cut prices, it could lose its patent protection to generics.

Colombia’s government is giving pharmaceutical giant Novartis a few weeks to lower prices on a popular cancer drug or see its monopoly on production of the medicine broken and competition thrown open to generic rivals.

Health Minister Alejandro Gaviria’s remarks in an interview Tuesday are the strongest yet in an increasingly public fight with the world’s biggest drugmaker that could set a precedent for middle-income countries grappling to contain rising prices for complex drugs.

Memos leaked last week to a nonprofit group, written from the Colombian Embassy in Washington, describe intense lobbying pressure on Colombia, a staunch U.S. ally, from the pharmaceutical industry and its allies in the U.S. Congress.

In one memo, the embassy warns that breaking Novartis’ patent for the leukemia drug Gleevec could hurt U.S. support for Colombia’s bid to join the proposed Trans-Pacific Partnership trade zone and even jeopardize $450 million in U.S. assistance for a peace deal with leftist rebels. The memos followed meetings between Colombian diplomats and officials from the Office of the U.S. Trade Representative and a Republican staffer on the Senate Finance Committee whose chairman, Sen. Orrin Hatch of Utah, has close ties to the pharmaceutical industry.

Gaviria, an economist by training, said the pressure shows the forceful steps that the pharmaceutical industry is willing to take to protect its commercial interests.

“They’re very afraid that Colombia could become an example that spreads across the region,” he said.

Government health programs in many countries are being squeezed by high prices for newly launched drugs and by annual price hikes of 10% or more for medicines long on the market, and they are increasingly pushing back by demanding big discounts or setting price caps on ultra-expensive drugs.

Gaviria denies he is trying to set a precedent in the global fight for lower prices.

“For us, it’s a question of survival,” he said. He noted Colombia’s health care system guarantees patients’ access to all approved drugs and the budget is straining after years of price rises. In 2009, the government declared a public health emergency after spending on sophisticated drugs had risen tenfold in just a few years.

“As the state, you can’t just buy everything at the price set by whoever is selling. But unfortunately that’s what happened many times,” Gaviria said.

Novartis has rejected Gaviria’s proposal to reduce the price for Gleevec to 140 pesos (5 U.S. cents) per milligram. That is less than half the current regulated price but still well above what generic versions cost before they were banned when, after a decade of litigation, a Colombian court in 2012 awarded Novartis an exclusive patent on one of two forms of the drug.

In an April 20 letter, Novartis’ local affiliate said that it doesn’t consider it convenient to initiate negotiations over prices and that the decision to override patents should be taken only in exceptional circumstances and not used as a bargaining tool.

Gaviria said he is giving Novartis a little time to reconsider. But if the Swiss company doesn’t, he said, he plans to declare access to the leukemia medicine a matter of public interest when he returns from a trip next week to Geneva to attend a meeting of the World Health Organization.

Gleevec has been the top-selling drug for Novartis since 2012, bringing in $4.7 billion worldwide last year, or about 10% of the company’s total revenue. It won’t be the top seller much longer, though. Gleevec got generic competition on Feb. 1 in the U.S., which accounts for half of its sales. As a result, in 2016’s first quarter, Gleevec sales fell 40% in the U.S. and 20% worldwide.

In Colombia, the patent is due to expire in July 2018.

Novartis spokesman Eric Althoff declined to answer questions on what his company is trying to achieve in its talks with the Colombian government. He also would not say whether Novartis enlisted U.S. officials to push the government against ending its patent here for the drug, which is called Glivec in Colombia and some other countries.

The company is “actively seeking a resolution to discussions around our Glivec patent in Colombia that benefits patients, innovation and the health care system,” Althoff said in an email.

Novartis says that the drug has been subject to Colombian price controls since 2011 and that two generic versions exist. But the Health Ministry says generic competition that previously existed has been all but driven out by Novartis’ aggressive marketing and competitors’ fear of prosecution for infringing the patent.

What’s not in dispute is how much Colombia stands to save from issuing so-called compulsory licenses. Cost for treatment with Glivec is about $15,000 a year, or about twice the average Colombian worker’s income. According to a study by the ministry, without competition from generics, the government would have to pay an extra $15 million a year supplying Glivec.

More than 100 lawyers and health experts from around the world sent a letter to Colombia’s government this week to support its efforts.

“The pressure against Colombia is bogus but it’s real,” said Andrew Goldman, a counsel for Knowledge Ecology International, the Washington-based group that first obtained the embassy memos. “We always assume that this kind of intervention is happening behind the scenes but rarely do you get the chance to see it up close.”

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Three Disney World Employees Among 17 Arrested in Florida Child Sex Sting

Three Disney World employees were among the 17 people arrested in a child sex sting operation in Florida, law enforcement officials announced on Wednesday.

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Three Disney World Employees Among 17 Arrested in Florida Child Sex Sting

Three Disney World employees were among the 17 people arrested in a child sex sting operation in Florida, law enforcement officials announced on Wednesday.

In the operation, dubbed “Operation Child Protector,” undercover officers posed as 13- and 14-year-old children on social media and online dating apps between July 27 and Aug. 1.

The undercovers made contact with each of the suspects before proposing they meet at a location in Polk County, where they were busted.

In total, the arrests led to 49 felony and two misdemeanor charges. Those arrested were aged 26 to 47. All were from Central Florida except for one 33-year-old man from California.

“What you see on this board … are deviants. Incredible deviants,” Polk County Sheriff Grady Judd said at a press conference on Tuesday, motioning to photos of the alleged pervs. “They travel from as far away as Clewiston, Florida. One even came from Los Angeles.”

“Much to their chagrin, instead of meeting with young children, they were met by law enforcement officers who were online undercover posing as children.”

Kenneth Javier Aquino, 26, a lifeguard at Animal Kingdom Lodge at Disney World, was arrested while still wearing his Disney polo shirt and swimsuit, according to the sheriff’s office.

Aquino engaged in an online conversation on social media with an officer, posing as a 13-year-old girl, authorities said. He then asked the “girl” to send photos, and sent her an explicit video of himself, police said.

Aquino told officers he is a Navy veteran and has a pregnant girlfriend.

Jonathan McGrew, a 34-year-old custodian at Disney World, was nabbed by an undercover officer posing as a 13-year-old girl.

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McGrew allegedly told the “girl” that he wanted her to come over and have sex with him and his girlfriend, 29-year-old Savannah Lawrence, who also works as a custodian at tourist mecca.

McGrew sent her explicit videos of him and Lawrence performing sexual acts on each other, authorities said.

A rep for Disney World didn’t immediately return a message.

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China Reports First Human Death from Monkey B Virus

China has reported the first human infection and death in the country caused by a rare infectious disease found in primates known as the Monkey B virus.

The Chinese Center for Disease Control and Prevention said a 53-year-old veterinary surgeon who worked in a research institute specializing in nonhuman primate breeding in Beijing dissected two monkeys in March and became ill about a month later.

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China Reports First Human Death from Monkey B Virus

China has reported the first human infection and death in the country caused by a rare infectious disease found in primates known as the Monkey B virus.

The Chinese Center for Disease Control and Prevention said a 53-year-old veterinary surgeon who worked in a research institute specializing in nonhuman primate breeding in Beijing dissected two monkeys in March and became ill about a month later.

He began experiencing nausea, vomiting, fever and neurological issues, and died in May.

Blood and saliva samples were tested and researchers in April found evidence of the Monkey B virus, also known as the herpes B virus.

Researchers said a male doctor and female nurse who were in close contact with the victim tested negative for the virus.

The Monkey B virus is prevalent among macaque monkeys but infection among humans is extremely rare. Since the virus was identified in 1932, just 50 cases have been reported, with the majority of those in North America. Untreated B virus infections in humans are serious, however, with a fatality rate of about 80 percent.

Symptoms include fever, shortness of breath, and progress to more serious complications such as swelling of the brain and spinal cord.

Laboratory workers and veterinarians in close contact with the animals are most at risk as people typically get infected with the virus if they are bitten or scratched by an infected macaque, or have contact with the monkey’s eyes, nose or mouth.

But the virus is unlikely to mutate in a way that poses a problem to the general population. Just one case of human-to-human transmission of the virus has ever been documented.

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U.S. Remembers 9/11 Terrorist Attacks as The Pandemic Changes Tribute Traditions

Americans are commemorating 9/11 with tributes that have been altered by coronavirus precautions and woven into the presidential campaign, drawing both President Donald Trump and Democratic challenger Joe Biden to pay respects at the same memorial without crossing paths.

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U.S. Remembers 9/11 Terrorist Attacks as The Pandemic Changes Tribute Traditions

Americans are commemorating 9/11 with tributes that have been altered by coronavirus precautions and woven into the presidential campaign, drawing both President Donald Trump and Democratic challenger Joe Biden to pay respects at the same memorial without crossing paths.

In New York, a dispute over coronavirus-safety precautions is leading to split-screen remembrances Friday, one at the Sept. 11 memorial plaza at the World Trade Center and another on a nearby corner. The Pentagon’s observance will be so restricted that not even victims’ families can attend, though small groups can visit the memorial there later in the day.

Trump and Biden are both headed — at different times — to the Flight 93 National Memorial near Shanksville, Pennsylvania.

Trump is speaking at the morning ceremony, the White House said. Biden plans to pay respects there in the afternoon after attending the observance at the 9/11 memorial in New York.

Meanwhile, Vice President Mike Pence is also due at ground zero — and then at the alternate ceremony a few blocks away.

In short, the anniversary of 9/11 is a complicated occasion in a maelstrom of a year, as the U.S. grapples with a health crisis, searches its soul over racial injustice and prepares to choose a leader to chart a path forward.

Still, 9/11 families say it’s important for the nation to pause and remember the hijacked-plane attacks that killed nearly 3,000 people at the trade center, at the Pentagon and near Shanksville on Sept. 11, 2001, shaping American policy, perceptions of safety and daily life in places from airports to office buildings.

“I know that the heart of America beats on 9/11 and, of course, thinks about that tragic day. I don’t think that people forget,” says Anthoula Katsimatides, who lost her brother John and is now on the board of the National Sept. 11 Memorial & Museum.

Friday will mark Trump’s second time observing the 9/11 anniversary at the Flight 93 memorial, where he made remarks in 2018. Biden spoke at the memorial’s dedication in 2011, when he was vice president.

The ground zero ceremony in New York has a longstanding custom of not allowing politicians to speak, though they can attend. Biden did so as vice president in 2010, and Trump as a candidate in 2016.

Though the candidates will be focused on the commemorations, the political significance of their focus on Shanksville is hard to ignore: Pennsylvania is a must-win state for both. Trump won it by less than a percentage point in 2016.

Around the country, some communities have canceled 9/11 commemorations because of the pandemic, while others are going ahead, sometimes with modifications.

The New York memorial is changing one of its ceremony’s central traditions: having relatives read the names of the dead, often adding poignant tributes.

Thousands of family members are still invited. But they’ll hear a recording of the names from speakers spread around the vast plaza, a plan that memorial leaders felt would avoid close contact at a stage but still allow families to remember their loved ones at the place where they died.

But some victims’ relatives felt the change robbed the observance of its emotional impact. A different 9/11-related group, the Stephen Siller Tunnel to Towers Foundation, set up its own, simultaneous ceremony a few blocks away, saying there’s no reason that people can’t recite names while keeping a safe distance.

The two organizations also tussled over the Tribute in Light, a pair of powerful beams that shine into the night sky near the trade center and evoke its fallen twin towers. The 9/11 memorial initially canceled the display, citing virus-safety concerns for the installation crew. After the Tunnel to Towers Foundation vowed to put up the lights instead, the memorial changed course with help from its chairman, former Mayor Mike Bloomberg, and Gov. Andrew Cuomo.

Tunnel to Towers, meanwhile, arranged to display single beams for the first time at the Shanksville memorial and the Pentagon.

Over the years, the anniversary also has become a day for volunteering. Because of the pandemic, the 9/11 National Day of Service and Remembrance organization is encouraging people this year to make donations or take other actions that can be accomplished at home.

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