Philippines orders probe into Sanofi dengue vaccine for 730,000 children

Concepcion Yusop, a national immunization program manager, shows an anti-dengue vaccine Dengvaxia inside a vaccine storage room in Sta. Cruz city, Metro Manila, Philippines December 4, 2017. REUTERS/Romeo Ranoco

By Manolo Serapio Jr and Neil Jerome Morales

MANILA (Reuters) – The Philippines ordered an investigation on Monday into the immunization of more than 730,000 children with a vaccine for dengue that has been suspended following an announcement by French drug company Sanofi <SASY.PA> that it could worsen the disease in some cases.

The World Health Organization said it hoped to conduct a full review by year-end of data on the vaccine, commercially known as Dengvaxia. In the meantime, the WHO recommended that it only be used in people who had a prior infection with dengue.

The government of Brazil, where dengue is a significant health challenge, confirmed it already had recommended restricted use of the vaccine but had not suspended it entirely.

Amid mounting public concern, Sanofi explained its “new findings” at a news conference in Manila but did not say why action was not taken after a WHO report in mid-2016 that identified the risk it was now flagging.

A non-governmental organization (NGO) said it had received information that three children who were vaccinated with Dengvaxia in the Philippines had died and a senator said he was aware of two cases.

However, Department of Health Undersecretary Gerardo Bayugo told Reuters the three referred to by the NGO died due to causes not related to the vaccine and Sanofi said no deaths had been reported as a result of the program.

“As far as we know, as far as we are made aware, there are no reported deaths that are related to dengue vaccination,” said Ruby Dizon, medical director at Sanofi Pasteur Philippines.

Last week, the Philippines Department of Health halted the use of Dengvaxia after Sanofi said it must be strictly limited due to evidence it can worsen the disease in people not previously exposed to the infection.

In a statement, Sanofi said the long-term safety evaluation of the vaccines showed significantly fewer hospitalizations due to dengue in vaccinated people over 9 years old compared with those who had not been vaccinated.

Nearly 734,000 children aged 9 and over in the Philippines have received one dose of the vaccine as part of a program that cost 3.5 billion pesos ($69.54 million).

The Department of Justice on Monday ordered the National Bureau of Investigation to look into “the alleged danger to public health … and if evidence so warrants, to file appropriate charges thereon.”

There was no indication that Philippines health officials knew of any risks when they administered the vaccination.

However, the WHO said in a July 2016 research paper that “vaccination may be ineffective or may theoretically even increase the future risk of hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination regardless of age.”

Singapore’s Health Sciences Authority said last week that it flagged risks when Dengvaxia was approved there in October 2016, and was working with Sanofi to strengthen risk warnings on the drug’s packaging.

According to Sanofi in Manila, 19 licences were granted for Dengvaxia, and it was launched in 11 countries, two of which – the Philippines and Brazil – had public vaccination programs.

Brazil’s healthcare regulator Anvisa said in a statement that it now recommends that people who have never been infected with dengue not take the vaccine, which was approved for use in Brazil at the end of 2015.

It was not known whether many people have taken the vaccine, if it was part of any government immunization program or if any illnesses or deaths linked to the drug have been reported to the government.

Anvisa did not immediately respond to a request for comment, nor did the Health Ministry.

A spokesman for Sanofi in Paris was not immediately available for comment. “A SHAMELESS SCAM” A spokesman for Philippines President Rodrigo Duterte said on Sunday the government would hold to account those responsible for the program.

Former Health Secretary Janette Garin, who implemented the program under the administration of then-President Benigno Aquino, said she welcomed the investigation.

“In the event that there will be authorities who will point culpability to me, I am ready to face the consequences,” she told ANC TV. “We implemented it in accordance with WHO guidance and recommendations.”

Presidential spokesman Harry Roque said there had been no reported case of severe dengue infection since the vaccine was administered and urged the public “not to spread information that may cause undue alarm.”

Volunteers Against Crime and Corruption, an NGO, said it was checking a report that three children on the northern island of Luzon had died since being vaccinated in April 2016 but the Department of Health said the deaths were not due to Dengvaxia.

“When we evaluated the clinical records, it was not related to the dengue vaccination,” Bayugo said.

A prominent senator, Richard Gordon, told Reuters he was aware of two deaths – but gave no details – and said approval and procurement for the program was done with “undue haste.”

Dengue is a mosquito-borne tropical disease. Although it is not as serious as malaria, it is spreading rapidly in many parts of the world, killing about 20,000 people a year and infecting hundreds of millions.

While Sanofi’s Dengvaxia is the first-ever approved vaccine for dengue, scientists already recognized it was not perfect and did not protect equally against the four different types of the virus in clinical tests.

A new analysis from six years of clinical data showed Dengvaxia vaccine provides persistent protective benefit against dengue fever in those who had prior infection.

But for those not previously infected by the virus, more cases of severe disease could occur in the long term following vaccination, Sanofi said.

(Additional reporting by Karen Lema in Manila, John Geddie in Singapore and Brad Brooks in Sao Paulo and Anthony Boadle in Brasilia; Writing by John Chalmers; Editing by Raju Gopalakrishnan and Bill Trott)

Exclusive: U.S. health regulator Verma eyes new methods for drug pricing

FILE PHOTO – U.S. Administrator of the Centers for Medicare and Medicaid Services (CMS) Seema Verma (C) is joined by Concerned Women for America CEO Penny Nance (L) as she talks to reporters about President Trump’s signing of House Resolution 43, which allows states to withhold federal funds from facilities that provide abortion services, at the White House in Washington, U.S., April 13, 2017. REUTERS/Jonathan Ernst

By Caroline Humer

NEW YORK (Reuters) – The U.S. government is considering setting new payment methods aimed at curbing costs for Medicare and Medicaid coverage of breakthrough medical treatments with very high prices, particularly novel gene-based therapies for cancer and other diseases, a top health official said on Thursday.

Seema Verma, head of the Centers for Medicare and Medicaid Services (CMS), made the comments in an interview with Reuters on the sidelines of the Forbes Healthcare Summit in New York.

CMS, part of the U.S. Department of Health and Human Services (HHS), spends hundreds of billions of dollars annually on medicines for seniors, disabled people and low-income households through the huge Medicare and Medicaid programs. CMS does not negotiate prices or purchase drugs, but sets ground rules for the managed care companies and state Medicaid agencies that do.

“We are trying to do whatever we can to increase competition and give the (health insurance) plans more tools so that they can be better negotiators on our behalf,” Verma said.

Roughly 125 million Americans are covered by Medicare and Medicaid.

The United States is the world’s most expensive market for prescription drugs. Government agencies and private sector companies are struggling to cover the costs of new medicines that have made the most progress to date in treating cancer and rare genetic disorders, some with annual price tags of nearly $500,000.

Verma said one model under consideration was paying different prices for a single drug based on its success treating a particular condition, such as paying more for a therapy that works better for breast cancer than it does for lung cancer or liver cancer.

A second method would be to extend the payment of an extremely expensive medicine over a longer time-frame, rather than immediately after it is given to a patient, Verma added, saying both are being tested by private sector pharmacy benefit managers.

That approach could be particularly useful for gene-based therapies aimed at small patient populations, she said. One such treatment expected to be approved by early next year is Spark Therapeutics’ <ONCE.O> therapy for a genetic mutation that causes blindness in around 1,000 to 2,000 patients. Some industry experts expect it to carry a list price of as much as $1 million.

Earlier this year, drugmaker Novartis <NOVN.S> said it reached an agreement with CMS over its revolutionary new blood cancer drug Kymriah, which has a list price of $475,000. Novartis is paid based on the outcomes achieved among pediatric and young adult leukemia patients by the end of the first month.

A similar treatment that harnesses the immune system’s CAR-T cells from Gilead Sciences Inc’s <GILD.O> Kite Pharma unit was approved last month and costs $373,000. Other companies including Juno Therapeutics <JUNO.O> and BlueBird Bio <BLUE.O> have similar treatments in advanced clinical trials, all of which aim to cure the disease with a one-time treatment.

President Donald Trump has promised to curb drug costs, but little concrete action has been taken so far. CMS has begun seeking information from insurance plans and drug companies as it considers possible changes, Verma said.

Alex Azar, Trump’s nominee for HHS secretary, on Wednesday promised to address drug prices if confirmed to the job, where he would be Verma’s boss.

Some Democratic and Republican lawmakers, as well as healthcare experts, have urged Congress to enact new laws allowing the government to negotiate drug prices directly with manufacturers. In the meantime, Verma is focusing on what she is already authorized to do.

“We are trying to do whatever we can within the regulatory structure,” she said.

(Reporting by Caroline Humer; Editing by Michele Gershberg and Will Dunham)

FDA clears first medical device accessory for Apple Watch

Apple watches are seen at a new Apple store in Chicago, Illinois, U.S., October 19, 2017. REUTERS/John Gress

(Reuters) – The U.S. Food and Drug Administration on Thursday cleared a device embedded in an Apple Inc watch band that monitors a user’s heart rate, detects when something is amiss and prompts the user to take an electrocardiogram.

The device, made by AliveCor, pairs the ability to take a personal 30 second electrocardiogram (EKG) with a feature that uses artificial intelligence to continuously evaluate the correlation between heart and physical activity.

When the device, known as KardiaBand, detects that a user’s heart rate and activity are out of sync, it prompts the user to capture an EKG by touching the band. The results display instantly on the watch face.

The device is designed to capture information that can help doctors help manage atrial fibrillation, the most common heart arrhythmia that is a leading cause of stroke and affects more than 30 million people worldwide.

The device costs $199 and requires a subscription to the company’s premium service for $99 a year.

AliveCor said in a statement it uses advanced artificial intelligence, mobile, cloud and micro-electrode technology to change the dynamic in cardiac care.

(Reporting by Toni Clarke in Washington; editing by Diane Craft)

New vaccine, long-acting drug trials buoy hopes in HIV fight

A nurse (L) hands out a red ribbon to a woman, to mark World Aids Day, at the entrance of Emilio Ribas Hospital, in Sao Paulo December 1, 2014. REUTERS/Nacho Doce

By Ben Hirschler

LONDON (Reuters) – Researchers announced the launch of two big studies in Africa on Thursday to test a new HIV vaccine and a long-acting injectable drug, fuelling hopes for better ways to protect against the virus that causes AIDS.

The start of the three-year vaccine trial involving 2,600 women in southern Africa means that for the first time in more than a decade there are now two big HIV vaccine clinical trials taking place at the same time.

The new study is testing a two-vaccine combination developed by Johnson & Johnson <JNJ.N> (J&J) with the U.S. National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. The first vaccine, also backed by NIH, began a trial last November.

At the same time, GlaxoSmithKline’s <GSK.L> majority-owned ViiV Healthcare unit is starting another study enrolling 3,200 women in sub-Saharan Africa to evaluate the benefit of giving injections every two months of its experimental drug cabotegravir.

The ViiV initiative, which is expected to run until May 2022, also has funding from the NIH and the Gates Foundation.

Women are a major focus in the fight against the sexually transmitted disease since in Africa they account for more than half of all new HIV infections.

ViiV is also running another large study with its long-acting injection in HIV-uninfected men and transgender women who have sex with men. That study started in December 2016.

Although modern HIV drugs have turned the disease from a death sentence into a chronic condition and preventative drug treatment can help, a vaccine is still seen as critical in rolling back the pandemic.

The latest vaccine experiments aim to build on the modest success of a trial in Thailand in 2009, when an earlier vaccine showed a 31 percent reduction in infections.

“We’re making progress,” said J&J Chief Scientific Officer Paul Stoffels, who believes it should be possible to achieve effectiveness above 50 percent.

“That is the goal. Hopefully, we get much higher,” he told Reuters.

The new vaccines require one dose to prime the immune system and a second shot to boost the body’s response.

Significantly, J&J’s latest vaccine uses so-called mosaic technology to combine immune-stimulating proteins from different HIV strains, representing different types of virus from around the world, which should produce a “global” vaccine.

One reason why making an HIV vaccine has proved so difficult in the past is the variability of the virus.

Initial clinical results reported at an AIDS conference in Paris in July showed the mosaic vaccine was safe and elicited a good immune response in healthy volunteers.

Some 37 million individuals around the world currently have HIV and around 1.8 million became newly infected last year.

(Reporting by Ben Hirschler; editing by Andrew Heavens and Jason Neely)

WHO fears complacency as progress against malaria stalls

FILE PHOTO: An Anopheles stephensi mosquito obtains a blood meal from a human host through its pointed proboscis in this undated handout photo obtained by Reuters November 23, 2015. A known malarial vector, the species can found from Egypt all the way to China. REUTERS/Jim Gathany/CDC/Handout via Reuters

By Kate Kelland

LONDON (Reuters) – Progress in the global fight against malaria has stalled amid signs of flatlining funding and complacency that the mosquito-borne disease is less of a threat, the World Health Organization said on Wednesday.

Malaria infected around 216 million people in 91 countries in 2016, an increase of 5 million cases over the previous year, the WHO said in its annual World Malaria Report. It killed 445,000 people, about the same number as in 2015.

The vast majority of deaths were in children under the age of five in the poorest parts of sub-Saharan Africa.

“Globally … after an unprecedented period of success, we are no longer making progress,” said Abdisalan Noor, a WHO expert on malaria and lead author of the report. “I am concerned that we have become complacent.”

WHO Director-General Tedros Adhanom Ghebreyesus added that “in some countries and regions, we are beginning to see reversals in the gains achieved”.

Pedro Alonso, director of the WHO’s global malaria program, said that partly due to funding, and partly due to governments shifting focus away from malaria, the progress seen in the past decade is no longer being sustained.

“We want (this to be) a wake-up call to the malaria community,” he told reporters on a teleconference. “We are not on track, and we need to get back on track.”

Overall funding for malaria has leveled off since 2010. In 2016, an estimated $2.7 billion was invested in malaria control and elimination efforts globally. In 2015, funding totaled $2.9 billion – almost the same as in 2010.

The WHO says a minimum annual investment of $6.5 billion is needed by 2020 to meet targets on controlling malaria by 2030.

The WHO report found that when analyzed on a country-by-country per capita basis, funding in countries where there is a high threat of malaria has fallen to an average of less than $2 per year per person at risk.

Noor said that alongside stagnating funding, the report found “equally concerning” gaps in access to and use of vital malaria prevention, diagnostic and treatment tools such as bed nets, indoor spraying and primary healthcare.

Fewer than half of households in countries in sub-Saharan Africa have enough bed nets to protect against mosquito bites, and only about a third of children in Africa with a fever have access to free public health sector medical care.

Tedros, who spent many years as a government minister fighting malaria in Ethiopia before coming to the WHO, said it would take robust financial resources and political leadership to swing the pendulum back towards a malaria-free world

“We are up against a tough adversary. But I am also convinced that this is a winnable battle,” he said.

(Editing by Alison Williams and William Maclean)

Sign-up pace much slower in week 4 of 2018 Obamacare enrollment

FILE PHOTO: A sign on an insurance store advertises Obamacare in San Ysidro, San Diego, California, U.S., October 26, 2017. REUTERS/Mike Blake/File Photo

NEW YORK (Reuters) – The pace of people signing up for individual insurance under Obamacare slowed significantly during the fourth week of 2018 enrollment, as nearly 37 percent fewer people signed up for the health care plans than in the previous week, a U.S. government agency reported on Wednesday.

The U.S. Department of Health and Human Services said that 504,181 people signed up for 2018 Obamacare individual insurance in the 39 states that use the federal government website HealthCare.gov for the week ended Nov. 25, down from 798,829 people in the previous week. New consumer sign-ups fell to 152,243 from 220,323 in the previous week.

Total sign-ups reached 2.78 million during the first four weeks of enrollment, which lasts through Dec. 15.

The figures do not include enrollment in Washington, D.C. or the 11 states that run their own enrollment and websites. The subsidized individual insurance is part of former President Barack Obama’s healthcare law, often known as Obamacare.

(Reporting by Michael ErmanEditing by Chizu Nomiyama)

Health secretary nominee Azar says drug pricing a top priority

Alex Azar testifies during a Senate Health, Education, Labor and Pensions Committee hearing on his nomination to be Health and Human Services secretary on Capitol Hill in Washington, U.S., November 29, 2017. REUTERS/Yuri Gripas

By Yasmeen Abutaleb

WASHINGTON (Reuters) – Alex Azar, a former drug industry executive who Republicans have nominated to run the U.S. Department of Health and Human Services, on Wednesday promised to lower drug prices that he said are too high, saying he would look at abuse of patent laws that delays generic competition.

Azar, who worked at Eli Lilly & Co, said his top priorities would be drug pricing, affordable healthcare, Medicare innovation and the opioid crisis that has killed tens of thousands of Americans.

“The current system of pricing insulin and other medicines … that system is not working for the patients who have to pay out of pocket, and we have to recognize that impact,” Azar told members of the U.S. Senate Committee on Health, Education, Labor & Pensions during a hearing that is part of the confirmation process.

Both Democratic and Republican senators repeatedly pressed Azar, who is also a former drug industry lobbyist, on how he would rein in rising prescription drug prices.

The hearing grew contentious when Democratic Senator Elizabeth Warren pressed him on whether drug company chief executives should be held personally accountable for actions like price fixing and Azar declined to answer the question.

Two Democratic lawmakers last year called for a federal probe into whether Eli Lilly, Sanofi SA, Merck & Co and Novo Nordisk A/S colluded to set prices on insulin and other diabetes drugs.

Azar also said he would support a bipartisan Senate bill that would help stabilize the Affordable Care Act, Democratic former President Barack Obama’s signature domestic policy achievement. But he said he did not think the measure was a long-term solution to “problems inherent in the Affordable Care Act.”

(Reporting by Yasemeen Abutaleb, Writing by Caroline Humer; Editing by Chizu Nomiyama and Jonathan Oatis)

Europe’s HIV epidemic growing at alarming rate, WHO warns

FILE PHOTO: HIV self tests are displayed in a pharmacy in Bordeaux, France, September 15, 2015. REUTERS/Regis Duvignau

By Kate Kelland

LONDON (Reuters) – The number of people newly diagnosed with HIV in Europe reached its highest level in 2016 since records began, showing the region’s epidemic growing “at an alarming pace”, health officials said on Tuesday.

That year, 160,000 people contracted the virus that causes AIDS in the 53 countries that make up the World Health Organization’s European region, the agency said in a joint report with the European Center for Disease Prevention and Control (ECDC).

Around 80 percent of those were in eastern Europe, the report found.

“This is the highest number of cases recorded in one year. If this trend persists, we will not be able to achieve the … target of ending the HIV epidemic by 2030,” the WHO’s European regional director, Zsuzsanna Jakab, said in a statement.

The trend was particularly worrying, the organizations said, because many patients had already been carrying the HIV infection for several years by the time they were diagnosed, making the virus harder to control and more likely to have been passed on to others.

Early diagnosis is important with HIV because it allows people to start treatment with AIDS drugs sooner, increasing their chances of living a long and healthy life.

“Europe needs to do more in its HIV response,” said ECDC director Andrea Ammon. She said the average time from estimated time of infection until a person is diagnosed is three years, “which is far too long”.

The report said new strategies were needed to expand the reach of HIV testing – including self-testing services and testing provided by lay providers.

Almost 37 million people worldwide have the human immunodeficiency virus that causes AIDS. The majority of cases are in poorer regions such as Africa, where access to testing, prevention and treatment is more limited, but the HIV epidemic has also proved stubborn in wealthier regions like Europe.

The WHO European Region comprises 53 countries, with a population of nearly 900 million people.

The ECDC/WHO report found that over the past ten years, the rate of newly diagnosed HIV infections in this region has risen by 52 percent from 12 in every 100,000 of population in 2007 to 18.2 for every 100,000 in 2016.

That decade-long increase was “mainly driven by the continuing upward trend in the East,” the report said.

An ECDC study published earlier this year also found that around one in six new cases of HIV diagnosed in Europe are in people over the age of 50.

(Reporting by Kate Kelland; Editing by Andrew Heavens)

UK gives Pfizer world’s first over-the-counter Viagra approval

FILE PHOTO: The Pfizer logo is seen at their world headquarters in New York April 28, 2014. REUTERS/Andrew Kelly/File Photo

LONDON (Reuters) – Pfizer’s big-selling erectile dysfunction drug Viagra has been given a green light for sale without a prescription in Britain, the first country to grant it over-the-counter status.

The U.S. drugmaker said on Tuesday it was working on plans to launch the non-prescription version of the medicine, known as Viagra Connect, in the United Kingdom in the spring of 2018.

The drug will only be available in pharmacies and its supply will depend on pharmacists’ assessment of its suitability for each individual.

Viagra has been one of the pharmaceutical industry’s most successful prescription products since its launch in 1998, following a serendipitous discovery of its effects by researchers who had been studying it as a heart medicine.

It achieved peak worldwide sales of more than $2 billion in 2012 but sales have since declined as patents have expired, prompting Pfizer to explore extending its brand value as a non-prescription drug.

Viagra is so far the only erectile dysfunction medicine to be reclassified from “prescription only medicine” to “pharmacy” status in Britain. The change follows a lengthy review by the Medicines and Healthcare products Regulatory Agency (MHRA).

Pfizer will continue to make Viagra available as a prescription drug but the option of also buying it over-the-counter is likely to reduce demand for potentially ineffective and dangerous fakes.

“It’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side effects,” said Mick Foy, the MHRA’s group manager in vigilance and risk management of medicines.

(Reporting by Ben Hirschler; Editing by Alexander Smith and Mark Potter)

Teva Pharm overhauls structure and top management

FILE PHOTO: The logo of Teva Pharmaceutical Industries, the world’s biggest generic drugmaker and Israel’s largest company, is seen in Jerusalem February 8, 2017. REUTERS/Ronen Zvulun/File Photo

By Tova Cohen and Ari Rabinovitch

TEL AVIV (Reuters) – Teva Pharmaceutical Industries is streamlining its company structure and making sweeping changes to senior management as part of an overhaul it hopes will please investors worried about the company’s massive debt.

Shares in the world’s largest generic drugmaker, which have been in a year-long freefall due to narrowing profit margins in generics and a series of pricey acquisitions, jumped 5.5 percent to $14.46 in early New York trade on Monday following the announcement.

Teva said it was combining its generics and specialty medicine groups into one commercial business and was doing the same for its research and development activities. Three senior officers will be stepping down as well.

“Our new company structure will enable stronger alignment and integration between R&D, operations and the commercial regions, allowing us to become a more agile, lean and profitable company,” said Chief Executive Kare Schultz, who joined the company at the start of November.

Teva is saddled with nearly $35 billion in debt since its $40.5 billion acquisition of Allergan’s generic drug business Actavis last year. That deal has not paid off and investors have been pushing for clarity regarding the future.

“Teva is taking decisive and immediate action to address external pressures and internal inefficiencies,” Schultz said, adding the company was working on a detailed restructuring plan to be unveiled in mid-December.

Hours earlier the Israeli company made a more vague promise for changes in a letter to the Israeli parliament, following media reports the company was set to cut thousands of jobs.

Parliament’s State Control Committee had called an emergency meeting to discuss reports that Teva was planning to cut up to a quarter of its 6,860-strong workforce in Israel, and a few thousand more staff in the United States.

Teva, which has already been selling off assets to help meet its debt payments, said in the letter it needed “deep, meaningful steps around the world,” but did not give details.

In its later statement, Teva said Chief Scientific Officer Michael Hayden, head of global specialty medicines Rob Koremans and Dipankar Bhattacharjee, head of the global generic medicines group, would retire at the end of the year.

The company also appointed Michael McClellan as permanent chief financial officer, after he held the role on an interim basis since July, and made five other executive changes at the top of the company.

(Editing by Mark Potter)

Founder of Germany’s failed Schlecker drugstore convicted, children jailed

Anton Schlecker arrives for the trial at a regional court in Stuttgart, Germany, November 27, 2017. REUTERS/Michaela Rehle

STUTTGART (Reuters) – The founder of Germany’s failed Schlecker drugstore chain got a suspended sentence and his two children got jail terms on Monday for offences relating to the company’s collapse.

Workers who lost their jobs when the firm shut its stores in 2012 cheered in court when the prison sentences were read out.

Anton Schlecker, 73, received a suspended two-year prison sentence and a 54,000-euro ($64,487) fine for intentional bankruptcy.

Prosecutors had demanded a three year-prison term, accusing him of siphoning off millions of euros from the company even as its financial situation worsened.

Under German law, removing assets from a company that faces imminent bankruptcy is illegal.

“He knew that company had reached the end of the line, and still kept hoping,” presiding judge Roderich Martis said in the regional court in Stuttgart.

Schlecker’s 46-year-old son Lars and daughter Meike, 44, were jailed for 33 and 32 months, respectively, for the more serious charge of embezzlement, alongside delaying insolvency proceedings and being an accessory to bankruptcy.

Unlisted Schlecker, a household name in Germany, filed for insolvency in January 2012, hit by competition from rivals Rossmann and dm and after failing to secure funding to upgrade its stores.

All 2,800 outlets closed that year, leaving around 23,000 employees out of work and draining the Schlecker family’s multi-billion-euro fortune.

Anton Schlecker, who went bankrupt after his company’s collapse, had told the court in March that he never saw the insolvency coming and had not intended to misuse company funds for his family’s personal gain.

Lawyers representing his two children had also rejected the charges brought against them.

But judge Martis told the court in his closing statement that Schlecker had only 7 million euros of liquidity left by early 2011 and had no chance of obtaining loans to invest in its stores and pay its suppliers.

The company’s chances of survival were worsened further by the fact that Schlecker paid logistics company LDG, controlled by his children Lars and Meike, excessive rates to transport goods from warehouses to Schlecker’s stores, Martis said.

And only days before the insolvency filing, Anton Schlecker transferred 7 million euros of proceeds from commercial real estate sales to his children as a distribution of profits, Martis added.

The Schlecker family agreed in 2013 to return around 10 million euros to creditors and paid another 4 million euros this month as “reparation”, Anton Schlecker had told the court.

“But no former Schlecker worker will get a new job or lost wages from that money,” German labor union Verdi said on Monday.

(Reporting by Alexander Huebner; Writing by Maria Sheahan; Editing by Jason Neely and Andrew Heavens)

Facebook to expand artificial intelligence to help prevent suicide

FILE PHOTO: A 3D plastic representation of the Facebook logo is seen in this photo illustration May 13, 2015. REUTERS/Dado Ruvic/Illustration/File Photo

By David Ingram

SAN FRANCISCO (Reuters) – Facebook Inc will expand its pattern recognition software to other countries after successful tests in the U.S. to detect users with suicidal intent, the world’s largest social media network said on Monday.

Facebook began testing the software in the United States in March, when the company started scanning the text of Facebook posts and comments for phrases that could be signals of an impending suicide.

Facebook has not disclosed many technical details of the program, but the company said its software searches for certain phrases that could be clues, such as the questions “Are you ok?” and “Can I help?”

If the software detects a potential suicide, it alerts a team of Facebook workers who specialize in handling such reports. The system suggests resources to the user or to friends of the person such as a telephone help line. Facebook workers sometimes call local authorities to intervene.

Guy Rosen, Facebook’s vice president for product management, said the company was beginning to roll out the software outside the United States because the tests have been successful. During the past month, he said, first responders checked on people more than 100 times after Facebook software detected suicidal intent.

Facebook said it tries to have specialist employees available at any hour to call authorities in local languages.

“Speed really matters. We have to get help to people in real time,” Rosen said.

Last year, when Facebook launched live video broadcasting, videos proliferated of violent acts including suicides and murders, presenting a threat to the company’s image. In May Facebook said it would hire 3,000 more people to monitor videos and other content.

Rosen did not name the countries where Facebook was deploying the software, but he said it would eventually be used worldwide except in the European Union due to sensitivities, which he declined to discuss.

Other tech firms also try to prevent suicides. Google’s search engine displays the phone number for a suicide hot line in response to certain searches.

Facebook knows lots about its 2.1 billion users – data that it uses for targeted advertising – but in general the company has not been known previously to systematically scan conversations for patterns of harmful behavior.

One exception is its efforts to spot suspicious conversations between children and adult sexual predators. Facebook sometimes contacts authorities when its automated screens pick up inappropriate language.

But it may be more difficult for tech firms to justify scanning conversations in other situations, said Ryan Calo, a University of Washington law professor who writes about tech.

“Once you open the door, you might wonder what other kinds of things we would be looking for,” Calo said.

Rosen declined to say if Facebook was considering pattern recognition software in other areas, such as non-sex crimes.

(Reporting by David Ingram; Editing by Susan Thomas)

Venezuelans suffer as malaria outbreak spreads in drug-short nation

People gather outside a health center as they wait to get treatment for malaria, in San Felix, Venezuela November 3, 2017. REUTERS/William Urdaneta

By Maria Ramirez

CIUDAD GUAYANA, Venezuela (Reuters) – On a recent morning in Venezuela’s southern jungle state of Bolivar, Amanda Santamaria, her two sons, one daughter-in-law, and a granddaughter lined up in front of a shabby community health center in the hope of receiving treatment for malaria.

All five of them are afflicted by the mosquito-borne disease, which is rapidly spreading through Venezuela as an economic meltdown strips the country of medicine and doctors.

“We don’t know if this is a curse, but the entire area is awash in malaria,” said Santamaria, 56, suffering her second bout of the illness in the last three months and relying on palliative herbal teas because she has not found regular drugs.

The family was waiting with some 500 others under the scorching sun in the hope of receiving treatment.

Unsanitary conditions in Bolivar are thought to have led to a recent flare-up in malaria, a life-threatening disease that had been largely brought under control in Venezuela in the 1990s.

The outbreak was likely initially caused by illegal mining. The miners cut down rainforests and often work in pools of stagnant water, which favors the spread of mosquitoes and malaria.

In a rare release of data earlier this year, government statistics showed there were 240,613 cases of malaria last year, up 76 percent compared with 2015, with most in Bolivar.

The former Health Minister was fired after the data was published, and it has not been updated since.

The government did not respond to a request for comment on the malaria outbreak.

On a visit to Bolivar in early November, the vice minister for health, Moira Tovar, said the outbreak in the state would be controlled within three months. She said that 32 people had died during just one week in late October.

“What are (these deaths) due to? They’re due to people who are infected and who know about the illness but don’t visit health centers on time. Instead they wait for the condition to worsen before seeking attention,” she said.

MALARIA SPREADS TO CITIES

The government has not given an overall death toll.

But health activists and doctor groups estimate that around 200 people have died from malaria over the last year nationwide, and fear the illness is starting to afflict populated urban centers.

“The mines have a high proportion of young adults, but their kids and pregnant partners are in the cities, and that’s a bigger problem: the entire family is at risk of falling ill,” said doctor and former health minister Jose Felix Oletta, a government critic.

The regional arm of the World Health Organization last month announced the arrival of over one million anti-malarial pills, which doctors deem insufficient. Patients must visit their nearest health center up to four times to complete treatment in what officials say is an attempt to avoid feeding the black market for drugs.

Still, in Venezuela’s shortages-hit economy, there is a black market for nearly everything.

“In the mines they offer you pills for a gram and a half of gold,” said Yudith Sanchez, a 28 year-old cook in an illegal gold mine.

Others have turned to brewing bark from cinchona trees, which was popular during the colonial era for its antiseptic properties.

“We’re going to die because there is no treatment,” said homemaker Yaritza Figuera, 29. Suffering from malaria, her nine year-old son sat on the floor in a health center because the waiting room was full.

(Reporting by Maria Ramirez, Writing by Eyanir Chinea and Alexandra Ulmer, Editing by Rosalba O’Brien)

U.S. approves digital pill that tracks when patients take it

A digital pill with an embedded sensor to track if patients are taking their medication. REUTERS/Proteus Digital Health

(Reuters) – U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health.

The system offers doctors an objective way to measure if patients are swallowing their pills on schedule, opening up a new avenue for monitoring medicine compliance that could be applied in other therapeutic areas.

Shares in Otsuka rose 2.5 percent on Tuesday after news of the U.S. Food and Drug Administration (FDA) late on Monday.

The FDA said that being able to track ingestion of medicines prescribed for mental illness may be useful “for some patients”, although the ability of the digital pill to improve patient compliance had not been proved.

“The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers,” said Mitchell Mathis of the FDA’s Center for Drug Evaluation and Research.

The system works by sending a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone.

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.

Poor compliance with drug regimens is a common problem in many disease areas, especially when patients suffer from chronic conditions.

Proteus has been working on the pill tracking system for many years and the sensor used in Abilify MyCite was first cleared for use by the FDA in 2012.

The unlisted Californian company has attracted investments from several large healthcare companies, including Novartis AG, Medtronic Inc and St. Jude Medical Inc, as well as Otsuka.

Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

(Reporting by Vibhuti Sharma and Ben Hirschler, Editing by Rosalba O’Brien and Louise Heavens)

Counting the costs: U.S. hospitals feeling the pain of physician burnout

Dr. Brian Halloran. a vascular surgeon at Saint Joseph Mercy Ann Arbor, shows the canned vegetables from his garden across from Saint Joseph Mercy hospital in Ypsilanti, Michigan, U.S., August 23, 2017. REUTERS/Rebecca Cook

By Julie Steenhuysen

ANN ARBOR, Mich. (Reuters) – Dr. Brian Halloran, a vascular surgeon at St. Joseph Mercy Ann Arbor, starts planning his garden long before spring arrives in southeast Michigan.

His tiny plot, located in the shadow of the 537-bed teaching hospital, helps Halloran cope with burnout from long hours and the stress of surgery on gravely ill patients.

“You really have to find the balance to put it a little more in perspective,” he said.

Hospitals such as St. Joseph Mercy Ann Arbor have been investing in programs ranging from yoga classes to personal coaches designed to help doctors become more resilient. But national burnout rates keep rising, with up to 54 percent of doctors affected.

Some leading healthcare executives now say the way medicine is practiced in the United States is to blame, fueled in part by growing clerical demands that have doctors spending two hours on the computer for every one hour they spend seeing patients.

What’s more, burnout is not just bad for doctors; it’s bad for patients and bad for business, according to interviews with more than 20 healthcare executives, doctors and burnout experts.

“This really isn’t just about exercise and getting enough sleep and having a life outside the hospital,” said Dr. Tait Shanafelt, a former Mayo Clinic researcher who became Stanford Medicine’s first chief physician wellness officer in September.

“It has at least as much or more to do with the environment in which these folks are practicing,” he said.

Shanafelt and other researchers have shown that burnout erodes job performance, increases medical errors and leads doctors to leave a profession they once loved.

Hospitals can ill afford these added expenses in an era of tight margins, costly nursing shortages and uncertainty over the fate of the Affordable Care Act, which has put capital projects and payment reform efforts on hold.

“Burnout decreases productivity and increases errors. It’s a big deal,” said Cleveland Clinic Chief Executive Dr. Toby Cosgrove, one of 10 U.S. healthcare CEOs who earlier this year declared physician burnout a public health crisis.

WHAT TO DO?

Hospitals are just beginning to recognize the toll of burnout on their operations.

Experts estimate, for example, that it can cost more than a $1 million to recruit and train a replacement for a doctor who leaves because of burnout.

But no broad calculation of burnout costs exists, Shanafelt said. Stanford, Harvard Business School, Mayo and the American Medical Association are working on that. They have put together a comprehensive estimate of the costs of burnout at the organizational and societal level, which has been submitted to a journal for review.

In July, the National Academy of Medicine (NAM) called on researchers to identify interventions that ease burnout. Meanwhile, some hospitals and health insurers are already trying to lighten the load.

Cleveland Clinic last year increased the number of nurse practitioners and other highly trained providers by 25 percent to 1,600 to handle more routine tasks for its 3,600 physicians. It hired eight pharmacists to help with prescription refills.

Atrius Health, Massachusetts’ largest independent physicians group, is diverting unnecessary email traffic away from doctors to other staffers and simplifying medical records, aiming to cut 1.5 million mouse “clicks” per year.

Insurer UnitedHealth Group, which operates physician practices for more than 20,000 doctors through its Optum subsidiary, launched a program to help doctors quickly determine whether drugs are covered by a patient’s insurance plan during the patient visit. It is also running a pilot program for Medicare plans in eight states to shrink the number of procedures that require prior authorization.

Similarly, Aetna Inc this year began a behavioral health program that eliminates prior authorization requirements for admission to some high-performing hospitals.

DOCTOR OVERLOAD

Experts define burnout as a syndrome marked by emotional exhaustion, cynicism and decreased effectiveness. Many burned out doctors cut back their hours to cope, and a disturbing number commit suicide.

A landmark 2015 Mayo Clinic study found that more than 7 percent of nearly 7,000 doctors had considered suicide within the prior 12 months, compared with 4 percent of other workers. About 400 a year go through with it.

Driving the burnout symptoms is the burden of data entry on clumsy electronic medical records systems that doctors must use to prove the quality of their care, said Dr. Christine Sinsky, vice president of professional satisfaction at the American Medical Association.

Sinsky recently conducted an experiment in her own internal medicine practice in Dubuque, Iowa. She asked a staff member how many mouse clicks it takes to order and record a single patient’s flu shot in their electronic medical record. The answer: 32.

She has visited some practices where a doctor had to record flu shots for more than 1,000 patients because only the doctor was allowed to enter the order.

Such mandates reflect an overly strict interpretation of federal health reforms designed to encourage doctors to use electronic medical records, such as the 2009 Health Information Technology for Economic and Clinical Health Act that required doctors to demonstrate “meaningful use” of the systems.

“We have to recognize the exacting toll that the first generation of electronic health records have had on physicians,” Sinsky said. “I would identify it as one of the most important drivers of physician burnout.”

Pre-approval requirements from health insurers for many services and quality metrics built into Obamacare have added to doctors’ administrative duties.

“We’ve got this measurement mania. We’ve got to back off of that,” said Dr. Paul Harkaway, chief accountable care officer for Michigan’s St. Joseph Mercy Health System, a part of Trinity Health, a national not-for-profit Catholic healthcare system.

As a result of these requirements, primary care physicians spend more than half of their 11.4 hour workday performing data entry and other tasks, according to a September AMA/University of Wisconsin study published in the Annals of Family Medicine.

To manage, doctors often finish work at home in the evening, a part of the day known as “pajama time.”

COSTS TO THE HEALTHCARE SYSTEM

Doctors’ suffering can take a direct toll on patients. In a 2010 study, Shanafelt and colleagues found that the more burned out a surgeon was, the more likely he or she was to report a major medical error. Other studies have shown that burnout drives up rates of unnecessary testing, referrals to specialists and hospital admissions.

When doctors quit, it costs an estimated $800,000 to $1.3 million in recruitment, training and productivity costs, depending on the specialty.

Even when physicians don’t leave, they can contribute thousands of dollars in costs each year “just as a matter of inefficient functioning,” said Dr. Colin West of the Mayo Clinic.

The trend has medical malpractice experts concerned. CRICO, the malpractice carrier for Harvard University’s two dozen affiliated hospitals, recently had to settle a handful of cases because doctors were too burned out to fight, even though CRICO believed it could win.

“The clinician just wanted it to go away,” said Dr. Luke Sato, CRICO’s chief medical officer. Sato estimates that an average breast or colorectal cancer malpractice case might cost $750,000 to $1 million to settle.

The crisis has Harkaway worried for his colleagues in Michigan, and for his profession.

“Working with doctors every day, you see it,” he said. “They are just beat down.”

(Reporting by Julie Steenhuysen; Editing by Michele Gershberg and Editing by Edward Tobin)

Roche stock up $12 billion on cancer, hemophilia trials; rivals hit

FILE PHOTO: FILE PHOTO: Swiss drugmaker Roche’s logo is seen at their headquarters in Basel, Switzerland January 28, 2016. REUTERS/Arnd Wiegmann/File Photo

By John Miller

ZURICH (Reuters) – Roche shares were lifted on Monday by two trial wins for its new cancer and hemophilia drugs, potential blockbusters that the Swiss drugmaker is counting on to offset shrinking revenue from older medicines.

Along with Roche’s multiple sclerosis medicine Ocrevus, the drugs are pillars of Chief Executive Severin Schwan’s plan to offset the patent expiry of top-sellers Rituxan, Avastin and Herceptin which account for $20 billion in annual sales.

Roche said Tecentriq had cut the risk of lung cancer worsening when mixed with other treatments, while hemophilia agent Hemlibra had reduced bleeds in a new group of patients. This weighed on other pharmaceutical stocks – Shire, a rival in the hemophilia market, fell 3 percent, while Merck & Co and Bristol-Myers Squibb, key competitors in cancer, fell 2.5 and 1.3 percent respectively.

Roche’s shares were up 6.5 percent at 1555 GMT, adding more than $12 billion to the company’s market capitalization.

Analysts said the trial results put Roche’s defense strategy on firmer ground.

“We view these results as likely sufficient to begin turning the tide of biosimilar pessimism,” Barclays analyst Emmanuel Papadakis, who has an “overweight” rating on the shares, said.

Biosimilars — biological drugs with the same effectiveness as the older name-brand medicines they mimic — are quickly winning approval and denting Roche’s revenue. Samsung Bioepis on Sunday won approval for a Herceptin copy in Europe.

CANCER COCKTAIL

With lung cancer easily the largest oncology market, Roche’s trial of Tecentriq, Avastin and chemotherapy has been closely watched as it seeks to catch rivals in cancer immunotherapy.

The mixture “provided a statistically significant and clinically meaningful reduction” in the risk of disease worsening or death compared to Avastin plus chemotherapy in first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC), Roche said.

Initial observations on improving overall survival were “encouraging” and will be reported in the first half of 2018, it added.

“We are extremely encouraged by these results and will submit these data to health authorities globally with the goal of bringing a potential new standard of care for the initial treatment of lung cancer,” Sandra Horning, Roche’s chief medical officer, said.

So far, Tecentriq’s sales – expected at around $500 million this year – pale compared to Keytruda from Merck and Opdivo from Bristol-Myers.

Keytruda, which has an edge in lung cancer after U.S. approval as a first-line treatment, should hit $3.7 billion in sales this year, analysts estimate, while Opdivo revenue is on track to rise nearly four-fold to $4.8 billion.

Monday’s readout from Roche, while giving only bare details, may help the Basel-based drugmaker make up ground, since results from Merck’s and BMS’s own combination lung cancer trials are still some way off.

Meanwhile, AstraZeneca’s immuno-oncology drug cocktail against lung cancer failed earlier this year, raising concerns about the approach as chemotherapy combinations like Roche’s rack up trial wins.

Hemlibra’s latest trial result comes after the $482,000-per-year medicine was approved last week in the United States for patients who have developed resistance to clotting factors.

In Monday’s readout, Roche’s drug reduced the risk of treated bleeds in patients without resistance.

Peak sales of Hemlibra, estimated by some analysts at more than $4 billion, will hinge on getting approval for all hemophilia patients.

“Hemlibra is poised to become a major product in the hemophilia A market … while Tecentriq could now become an important first-line option in non-small-cell lung carcinoma,” said Berenberg analyst Alistair Campbell.

(Additional reporting by Ben Hirschler in London; Editing by Michael Shields and Andrew Heavens)

Injured defector’s parasites and diet hint at hard life in North Korea

FILE PHOTO: A North Korean flag flutters on top of a tower at the propaganda village of Gijungdong in North Korea, in this picture taken near the truce village of Panmunjom, South Korea, August 26, 2017. REUTERS/Kim Hong-Ji

By Josh Smith and Hyonhee Shin

SEOUL (Reuters) – Parasitic worms found in a North Korean soldier, critically injured during a desperate defection, highlight nutrition and hygiene problems that experts say have plagued the isolated country for decades.

At a briefing on Wednesday, lead surgeon Lee Cook-jong displayed photos showing dozens of flesh-colored parasites – including one 27 cm (10.6 in) long – removed from the wounded soldier’s digestive tract during a series of surgeries to save his life.

“In my over 20 year-long career as a surgeon, I have only seen something like this in a textbook,” Lee said.

The parasites, along with kernels of corn in his stomach, may confirm what many experts and previous defectors have described about the food and hygiene situation for many North Koreans.

“Although we do not have solid figures showing health conditions of North Korea, medical experts assume that parasite infection problems and serious health issues have been prevalent in the country,” said Choi Min-Ho, a professor at Seoul National University College of Medicine who specializes in parasites.

The soldier’s condition was “not surprising at all considering the north’s hygiene and parasite problems,” he said.

The soldier was flown by helicopter to hospital on Monday after his dramatic escape to South Korea in a hail of bullets fired by North Korean soldiers.

He is believed to be an army staff sergeant in his mid-20s who was stationed in the Joint Security Area in the United Nations truce village of Panmunjom, according to Kim Byung-kee, a lawmaker of South Korea’s ruling party, briefed by the National Intelligence Service.

North Korea has not commented on the defection.

While the contents of the soldier’s stomach don’t necessarily reflect the population as a whole, his status as a soldier – with an elite assignment – would indicate he would at least be as well nourished as an average North Korean.

He was shot in his buttocks, armpit, back shoulder and knee among other wounds, according to the hospital where the soldier is being treated.

‘THE BEST FERTILIZER’

Parasitic worms were also once common in South Korea 40 to 50 years ago, Lee noted during his briefing, but have all but disappeared as economic conditions greatly improved.

Other doctors have also described removing various types of worms and parasites from North Korean defectors.

Their continued prevalence north of the heavily fortified border that divides the two Koreas could be in part tied to the use of human excrement, often called “night soil.”

“Chemical fertilizer was supplied by the state until the 1970s, but from the early 1980s, production started to decrease,” said Lee Min-bok, a North Korean agriculture expert who defected to South Korea in 1995. “By the 1990s, the state could not supply it anymore, so farmers started to use a lot of night soil instead.”

In 2014, supreme leader Kim Jong Un personally urged farmers to use human faeces, along with animal waste and organic compost, to fertilize their fields.

A lack of livestock, however, made it difficult to find animal waste, said Lee, the agriculture expert.

Even harder to overcome, he said, is the view of night soil as the “best fertilizer in North Korea,” despite the risk of worms and parasites.

“Vegetables grown in it are considered more delicious than others,” Lee said.

LIMITED DIETS

The medical briefing described the wounded soldier as being 170 cm (5 feet 5 inches) and 60 kg (132 pounds) with his stomach containing corn. It’s a staple grain that more North Koreans may be relying on in the wake of what the United Nations has called the worst drought since 2001.

Imported corn, which is less preferred but cheaper to obtain than rice, has tended to increase in years when North Koreans are more worried about their seasonal harvests.

Between January and September this year, China exported nearly 49,000 tonnes of corn to North Korea, compared to only 3,125 tonnes in all of 2016, according to data released by Beijing.

Despite the drought and international sanctions over Pyongyang’s nuclear program, the cost of corn and rice has remained relatively stable, according to a Reuters analysis of market data collected by the defector-run Daily NK website.

Since the 1990s, when government rations failed to prevent a famine hitting the country, North Koreans have gradually turned to markets and other private means to feed themselves.

The World Food Programme says a quarter of North Korean children 6-59 months old, who attend nurseries that the organization assists, suffer from chronic malnutrition.

On average North Koreans are less nourished than their southern neighbors. The WFP says around one in four children have grown less tall than their South Korean counterparts. A study from 2009 said pre-school children in the North were up to 13 cm (5 inches) shorter and up to 7 kg (15 pounds) lighter than those brought up in the South.

“The main issue in DPRK is a monotonous diet – mainly rice/maize, kimchi and bean paste – lacking in essential fats and protein,” the WFP told Reuters in a statement last month.

(Additional reporting by Seung-woo Yeom, James Pearson, Heekyong Yang, Hyunjoo Jin, Soyoung Kim, Writing by Josh Smith, Editing by Bill Tarrant)

$1 million price tag in spotlight as gene therapy becomes reality

FILE PHOTO: A DNA double helix is seen in an undated artist’s illustration released by the National Human Genome Research Institute to Reuters on May 15, 2012. REUTERS/National Human Genome Research Institute/Handout/File Photo

By Ben Hirschler

LONDON (Reuters) – Battle lines are being drawn as the first gene therapy for an inherited condition nears the U.S. market, offering hope for people with a rare form of blindness and creating a cost dilemma for healthcare providers.

Spark Therapeutics <ONCE.O>, whose Luxturna treatment has been recommended for U.S. approval, told investors last week there was a case for valuing it at more than $1 million per patient, although it has yet to set an actual price.

However, the U.S. Institute for Clinical and Economic Review (ICER) said this week “at a placeholder price of $1,000,000, the high cost makes this unlikely to be a cost-effective intervention at commonly used cost-effectiveness thresholds”.

The ICER analysis did concede Luxturna was likely to be more cost-effective for younger patients.

The expected U.S. approval of Luxturna by Jan. 12 is seen as kick-starting the sector, following disappointing sales of the first two gene therapies in Europe.

More treatments based on fixing faulty genes using viruses to carry DNA into cells are coming from companies like Bluebird Bio <BLUE.O>, BioMarin <BMRN.O> and Sangamo <SGMO.O>.

Spark’s Chief Financial Officer Stephen Webster said on Thursday that gene therapy was upending conventional thinking by offering a one-time cure, rather than years of repeat prescriptions, but health systems were struggling to keep pace.

“Gene therapy creates an unusual conundrum because we are fitting a round peg in a square hole … it’s tough,” he told a Jefferies healthcare conference in London.

Spark would like to say “if it works, pay us, and if it stops working, stop paying us”, Webster told the meeting.

But for Luxturna, which cost some $400 million to develop, such an offer was impractical, given the mechanics of the U.S. system and a reluctance by big health plans to move away from upfront payments for rare disease drugs.

Longer-term, pay-for-performance models could be adopted for haemophilia, where the benefits of one-time treatment can be weighed against the huge cost of regular infusions of blood-clotting factors, Webster said.

A one-off treatment would slash the need for such expensive care. But there are also indirect costs and quality of life benefits – especially in a condition like blindness – that manufacturers argue should be recognized.

Nightstar Therapeutics <NITE.O> CEO David Fellows, whose company is also developing gene therapies for eye disorders, said calculating gene therapy’s true value was not easy.

“Trying to capture all this into some sort of price algorithm is very challenging. But we are trying to quantify the emotional impact, the care-giver impact, the effect on careers and so on,” he told the conference.

(Reporting by Ben Hirschler; editing by Alexander Smith)

Johnson & Johnson hit with $247 million verdict in hip implant trial

FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake

By Tina Bellon

NEW YORK (Reuters) – A federal jury in Dallas on Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.

Delivering a third straight win to patients, the jury found that the metal-on-metal hip implants were defectively designed and that the companies failed to warn consumers about the risks.

Six New York residents implanted with the devices said they experienced tissue death, bone erosion and other injuries they blamed on design flaws.

J&J, which faces more than 9,700 Pinnacle lawsuits in state and federal courts across the United States, said in a statement it would immediately begin the appeal process.

A DePuy spokeswoman said the company was still “committed to the long-term defense of the allegations in these lawsuits,” adding that the metal-on-metal hip implants were backed by a strong record of clinical data showing they were effective.

Plaintiffs claimed the companies falsely promoted the device, most commonly used to treat joint failure caused by osteoarthritis, by saying it lasted longer than similar implants that include ceramic or plastic materials.

“We thank this jury for sending a very strong message about the responsibility the defendants have to take care of their consumers,” Mark Lanier, who represented the New York patients, said in a statement.

Thursday’s verdict came in the fourth test trial over the devices in Dallas federal court, where some 9,000 of the cases are pending. Test cases have been selected for trial, and their outcomes will help gauge the value of the remaining claims and inform potential settlement talks.

J&J won the first Pinnacle test trial in 2014, but subsequent juries determined the companies to be liable.

“This nine-week trial was a disservice to everyone involved because the verdict will do nothing to advance the ultimate resolution of this six-year old litigation,” attorney John Beisner, who represented the companies, said in a statement. He said the firms would seek further appellate guidance.

A jury in March 2016 awarded five Texas plaintiffs $500 million in damages. That award was later cut to $150 million.

J&J and DePuy were also found liable at a trial in March, during which a jury awarded six California patients $1 billion – a verdict that was later reduced to $543 million.

DePuy ceased selling the metal-on-metal Pinnacle devices in 2013 after the U.S. Food and Drug Administration strengthened its artificial hip regulations.

(Reporting by Tina Bellon; Editing by David Gregorio and Dan Grebler)

Johnson & Johnson wins California lawsuit claiming asbestos in talc caused cancer

FILE PHOTO: Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York October 15, 2015. REUTERS/Lucas Jackson/File Photo

By Nate Raymond

(Reuters) – A California jury on Thursday ruled in favor of Johnson & Johnson in a lawsuit by a woman who said she developed the cancer mesothelioma after being exposed to asbestos in the company’s talc-based products including J&J’s Baby Powder.

The Los Angeles Superior Court jury’s verdict, watched by a Reuters reporter through an online broadcast by Courtroom View Network, came in the first trial centering on claims that J&J’s talc products contained asbestos.

J&J is separately battling thousands of cases claiming those products can cause ovarian cancer.

The lawsuit was filed by Tina Herford, who said she developed mesothelioma after using J&J talcum powder products that her lawyers claimed contained asbestos.

J&J said in a statement it was pleased with the verdict. The company said it believed that setbacks dealt to individuals pursuing the ovarian cancer cases had “forced plaintiff attorneys to pivot to yet another baseless theory.”

“Johnson’s Baby Powder has been around since 1894 and it does not contain asbestos or cause mesothelioma or ovarian cancer,” J&J said.

The jury also found in favor of talc supplier Imerys Talc.

Chris Panatier, Herford’s lawyer, in an email cautioned against reading too much into a single verdict, adding that J&J “is still selling contaminated baby powder.”

“It is a matter of time before juries begin holding them to account,” he said. “We just missed on the first one.”

Mesothelioma is a deadly form of cancer closely associated with exposure to asbestos that arises in the delicate tissue that lines body cavities, most often around the lungs, but also in the abdomen and elsewhere.

Herford’s lawyers contended that internal J&J documents showed the New Jersey-based company for decades was aware of the presence of asbestos in the talc that was used in its products but nonetheless continued to sell it.

J&J continues to fight lawsuits by around 5,500 plaintiffs nationally asserting talc-related claims. Most of the plaintiffs are women who say J&J failed to warn them about the risk of developing ovarian cancer from the products.

In five trials in Missouri involving ovarian cancer lawsuits, juries found J&J liable four times and awarded the plaintiffs $307 million. In California, a jury awarded a now-deceased woman $417 million.

But in October, J&J scored major victories when a Missouri appellate court threw out the first verdict there for $72 million and a California judge tossed the $417 million verdict.

The case is Herford et al v. AT&T Corp et al, Los Angeles Superior Court, No. BC646315.

(Reporting by Nate Raymond in Boston; Editing by Jeffrey Benkoe)

Billionaire founder of Insys to plead not guilty to opioid bribe scheme

FILE PHOTO: The billionaire founder of Insys Therapeutics Inc. John Kapoor, exits the federal court house after a bail hearing in Phoenix, Arizona , U.S., October 27, 2017. REUTERS/Conor Ralph/File Photo

By Nate Raymond

BOSTON (Reuters) – The billionaire founder of Insys Therapeutics Inc was expected to appear in federal court in Boston on Thursday to plead not guilty to charges that he participated in a scheme to bribe doctors to prescribe a fentanyl-based cancer pain drug.

John Kapoor, who stepped down as Insys’ chief executive officer and chairman in January but remains the majority shareholder, was charged last month with engaging in conspiracies to commit racketeering, mail fraud and wire fraud.

Brian Kelly, a lawyer for Kapoor, said on Monday that his client would plead not guilty. In court papers filed ahead of the hearing, lawyers for Kapoor, 74, called the allegations against the billionaire “thin, vague and conclusory.”

Kapoor’s arrest in Phoenix on Oct. 26 came as U.S. authorities have been fighting a national opioid addiction epidemic that the U.S. Centers for Disease Control and Prevention linked to more than 33,000 deaths in 2015, the latest year for which statistics are available.

The charges marked a major escalation of probes centered on Chandler, Arizona-based Insys’ flagship product Subsys, an under-the-tongue spray that contains fentanyl, an addictive synthetic opioid.

Following Kapoor’s arrest, Insys on Oct. 29 announced he had resigned from its board and it had recorded $150 million as its best estimate for the minimum amount it would have to pay to settle the U.S. Department of Justice probe.

Kapoor, who founded Insys in 2002, was charged in an indictment that added him as a defendant in a case against six former Insys executives and managers, including ex-CEO Michael Babich, who were initially charged in December 2016.

The indictment said that, beginning in 2012, Kapoor, Babich and others devised a scheme to pay speaker fees and other bribes to medical practitioners to prescribe Subsys and to defraud insurers into approving payment for it.

Federal charges have also been filed in several other states against other ex-Insys employees and medical practitioners who prescribed Subsys.

Insys also faces lawsuits by attorneys general in Arizona and New Jersey. It previously paid $9.45 million to resolve investigations by attorneys general in Oregon, New Hampshire, Illinois and Massachusetts.

(Reporting by Nate Raymond in Boston; Editing by David Gregorio)

Pope denounces healthcare inequality, says all should be protected

Pope Francis waves as he arrives to lead his Wednesday general audience in Saint Peter’s square at the Vatican, November 15, 2017. REUTERS/Tony Gentile

VATICAN CITY (Reuters) – Pope Francis condemned on Thursday inequality in healthcare, particularly in rich countries, saying governments had a duty to protect all citizens.

“Increasingly sophisticated and costly treatments are available to ever more limited and privileged segments of the population,” Francis said in an address to a conference of European members of the World Medical Association.

“This raises questions about the sustainability of healthcare delivery and about what might be called a systemic tendency toward growing inequality in healthcare,” he said.

The tendency was clearly apparent when you compared healthcare cover between countries and continents, the pope said, adding that it was also visible within more wealthy countries, “where access to healthcare risks being more dependent on individuals’ economic resources than on their actual need for treatment.”

Francis did not mention any countries. Healthcare is a big issue in the United States, where President Donald Trump has vowed to get rid of the Affordable Care Act, introduced by his predecessor, Barack Obama, which aimed to make it easier for lower-income households to get health insurance.

The pope said “the state cannot renounce its duty to protect all those involved, defending the fundamental equality whereby everyone is recognized under law as a human being living with others in society”.

He said healthcare legislation needed a “broad vision and a comprehensive view of what most effectively promotes the common good in each concrete situation.”

(Reporting by Philip Pullella; Editing by Robin Pomeroy)

Monsanto, U.S. farm groups sue California over glyphosate warnings

Monsanto Co’s Roundup is shown for sale in Encinitas, California, U.S., June 26, 2017. REUTERS/Mike Blake

By Tom Polansek

CHICAGO (Reuters) – Monsanto Co and U.S. farm groups sued California on Wednesday to stop the state from requiring cancer warnings on products containing the widely used weed killer glyphosate, which the company sells to farmers to apply to its genetically engineered crops.

The government of the most populous U.S. state added glyphosate, the main ingredient in Monsanto’s herbicide Roundup, to its list of cancer-causing chemicals in July and will require that products containing glyphosate carry warnings by July 2018.

California acted after the World Health Organization’s International Agency for Research on Cancer (IARC) concluded in 2015 that glyphosate was “probably carcinogenic”.

For more than 40 years, farmers have applied glyphosate to crops, most recently as they have cultivated genetically modified corn and soybeans. Roundup and Monsanto’s glyphosate-resistant seeds would be less attractive to customers if California requires warnings on products containing the chemical.

In the lawsuit, filed in federal court in California, Monsanto and groups representing corn, soy and wheat farmers reject that glyphosate causes cancer. They say the state’s requirement for warnings would force sellers of products containing the chemical to spread false information.

“Such warnings would equate to compelled false speech, directly violate the First Amendment, and generate unwarranted public concern and confusion,” Scott Partridge, Monsanto’s vice president of global strategy, said in a statement.

California’s Office of Environmental Health Hazard Assessment (OEHHA), which is named in the lawsuit, said it generally does not comment on pending litigation.

The controversy is an additional headache for Monsanto as it faces a crisis around a new version of an herbicide based on another chemical known as dicamba that was linked to widespread U.S. crop damage this summer. The company, which is being acquired by Bayer AG for $63.5 billion, developed the product as a replacement for glyphosate following an increase of weeds resistant to the chemical.

Monsanto has already suffered damage to its investment of hundreds of millions of dollars in glyphosate products since California added the chemical to its list of products known to cause cancer, according to the lawsuit.

U.S. farmers apply glyphosate to fields to kill weeds before planting corn fed to livestock, spray it on genetically engineered soybeans while they are growing and sometimes on wheat before it is harvested. The crops are then shipped across the country in food products.

“Everything that we grow is probably going to have to be labeled,” said Blake Hurst, president of the Missouri Farm Bureau, a plaintiff in the lawsuit.

Certain goods that meet a standard for containing low amounts of glyphosate, known as a No Significant Risk Level (NSRL), may be able to be sold without warnings under a proposal California is considering, said Sam Delson, a state spokesman.

“We do not anticipate that food products would cause exposures that exceed the proposed NSRL,” he said. “However, we cannot say that with certainty at this point and businesses make the determination.”

A large, long-term study on glyphosate use by U.S. agricultural workers, published last week as part of a project known as the Agricultural Health Study (AHS), found no firm link between exposure to the chemical and cancer.

Reuters reported in June that an influential scientist was aware of new AHS research data while he was chairing a panel of experts reviewing evidence on glyphosate for IARC in 2015. He did not tell the panel about it because the data had not been published, and IARC’s review did not take it into account.

A 2007 study by OEHHA also concluded the chemical was unlikely to cause cancer.

Still, flour mills have started asking farmers to test wheat for glyphosate in anticipation of California’s requirement, said Gordon Stoner, president of the National Association of Wheat Growers, another plaintiff.

Such tests add costs for farmers and could push up food prices or unnecessarily scare consumers away from buying products that contain crops grown with glyphosate, he said.

The case is National Association of Wheat Growers et al v. Lauren Zeise, director of the OEHHA, et al, U.S. District Court, Eastern District of California, No. 17-at-01224.

(Reporting by Tom Polansek; Editing by Tom Brown)

U.S. approves digital pill that tracks when patients take it

A digital pill with an embedded sensor to track if patients are taking their medication. REUTERS/Proteus Digital Health

(Reuters) – U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health.

The system offers doctors an objective way to measure if patients are swallowing their pills on schedule, opening up a new avenue for monitoring medicine compliance that could be applied in other therapeutic areas.

Shares in Otsuka rose 2.5 percent on Tuesday after news of the U.S. Food and Drug Administration (FDA) late on Monday.

The FDA said that being able to track ingestion of medicines prescribed for mental illness may be useful “for some patients”, although the ability of the digital pill to improve patient compliance had not been proved.

“The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers,” said Mitchell Mathis of the FDA’s Center for Drug Evaluation and Research.

The system works by sending a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone.

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.

Poor compliance with drug regimens is a common problem in many disease areas, especially when patients suffer from chronic conditions.

Proteus has been working on the pill tracking system for many years and the sensor used in Abilify MyCite was first cleared for use by the FDA in 2012.

The unlisted Californian company has attracted investments from several large healthcare companies, including Novartis AG, Medtronic Inc and St. Jude Medical Inc, as well as Otsuka.

Abilify MyCite is not approved to treat patients with dementia-related psychosis and contains a boxed warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

(Reporting by Vibhuti Sharma and Ben Hirschler, Editing by Rosalba O’Brien and Louise Heavens)

FDA warns against using kratom for opioid addiction

FILE PHOTO: Tablets of the opioid-based Hydrocodone at a pharmacy in Portsmouth, Ohio, June 21, 2017. REUTERS/Bryan Woolston/File Photo

(Reuters) – The U.S. Food and Drug Administration warned on Tuesday about the usage of kratom, citing reports of 36 deaths, and said there is no reliable evidence to support its use to treat opioid withdrawal symptoms.

Kratom, which is a naturally growing plant in Thailand, Malaysia, Indonesia and Papua New Guinea, is increasingly being used to treat pain, anxiety, depression and opioid addiction in the United States, at a time when the country is already battling an ongoing opioid epidemic.

Kratom has similar effects to narcotics like opioids and carries similar risks of abuse, addiction and in worst cases, death, the FDA noted.

There have been 36 deaths linked to the use of kratom-containing products, the FDA said, adding that the substance is also being laced with other opioids like hydrocodone for marketing purposes.

Leaves of the kratom tree are usually brewed into a tea, chewed, smoked or ingested in capsules and can be used as either a stimulant or sedative.

The regulator said there are currently no approved therapeutic uses of kratom, which is linked to serious side effects such as seizures and liver damage.

Kratom is already a controlled substance in 16 countries worldwide and is also banned in states such as Alabama, Arkansas, Indiana, Tennessee and Wisconsin.

The FDA said it is working to prevent shipments of kratom in the United States and has detained hundreds of these packages at international mail facilities.

The health regulator has also taken action against kratom-containing dietary supplements.

(Reporting by Divya Grover in Bengaluru; Editing by Martina D’Couto)

Biotech firms race to recruit good bugs in war on cancer

A cancer cell (white) being attacked by two cytotoxic T cells (red), part of a natural immune response. REUTERS/Courtesy NIH

By Ben Hirschler

(Reuters) – Biotech companies are competing to develop medicines using “bugs as drugs” to fight cancer, building on the latest scientific findings that patients with high levels of good gut bacteria are more likely to respond to modern immunotherapy.

Certain bacteria seem to help in cancer by priming immune cells and smoothing the path for immunotherapy drugs known as PD-1 drugs that work by taking the brakes off the immune system.

Seres Therapeutics hopes to become the first company to leverage this discovery through a collaboration with the MD Anderson Cancer Center in Texas and the Parker Institute for Cancer Immunotherapy that will see its microbe medicine tested in a clinical trial.

The Cambridge, Massachusetts-based firm has an exclusive option to license patent rights under the deal announced on Tuesday.

MD Anderson scientists were among two groups of cancer researchers who reported on the benefits of good gut microbes in the journal Science earlier this month.

The work underscores the importance of the microbiome – the vast community of microbes living inside us – which has been linked to everything from digestive disorders to depression.

Seres Chief Executive Roger Pomerantz told Reuters the aim was to start the randomized, placebo-controlled clinical trial in metastatic melanoma in 2018, evaluating the impact of giving a newly developed Seres microbiome drug alongside a PD-1 therapy.

There are currently two approved PD-1 drugs, Merck & Co’s Keytruda or Bristol-Myers Squibb’s Opdivo, but Pomerantz declined to say which would be used.

Seres, which is backed by Swiss food giant Nestle, became the first microbiome drug developer to go public in June 2015 but it suffered a setback last year when its leading drug candidate failed in a trial against C. difficile, a debilitating gut infection.

BEYOND THE GUT

Other companies are competing hard. Like Seres, some are also eyeing the new opportunity in cancer, as microbiome science moves beyond the initial focus on gastrointestinal conditions like C. difficile, ulcerative colitis and inflammatory bowel disease.

Vedanta Biosciences, another U.S. biotech firm that is an affiliate of PureTech Health, plans to file for approval to start a clinical trial in immuno-oncology in 2018, while Synlogic is also working on experimental cancer therapies.

French biotech company Enterome, meanwhile, is working with Bristol-Myers on microbiome-derived diagnostic tests and potential drugs to use with the U.S. drugmaker’s immunotherapy medicines.

“This shift makes sense,” said Vedanta CEO Bernat Olle of the latest focus on cancer.

“About 80 percent of your immune system cells are in the intestine … but cells that are educated in the gut don’t stay there. Every day they cycle several times throughout the body and some of them will go to tumors.”

Advocates argue that microbiome medicine offers a smart way to both tone down the immune system response – useful for conditions like rheumatoid arthritis and allergies – or ramp it up, which is needed for the body to fight back against cancer.

The first wave of microbiome drugs rely on faecal microbiota transplantation (FMT), or samples of microbes distilled from human faeces, delivered either as a capsule or by enema. But companies are also working on synthetically fermented versions.

Seres boss Pomerantz believes microbiome science will open up a major new treatment field, like monoclonal antibodies did when they were pioneered by Centocor, now part of Johnson & Johnson, three decades ago.

“Just as Centocor started monoclonals back in the 1980s, we think we are the Centocor of the microbiome – but of course there will be other companies.”

(Reporting by Ben Hirschler; Editing by Hugh Lawson)

New blood pressure range means nearly half of Americans have hypertension

FILE PHOTO: A photo illustration shows a stethoscope and blood-pressure machine of a French general practitioner displayed in a doctor’s office in Bordeaux January 7, 2015. REUTERS/Regis Duvignau

By Deena Beasley

(Reuters) – Tighter blood pressure guidelines from U.S. heart organizations mean millions more people need to make lifestyle changes, or start taking medication, in order to avoid cardiovascular problems.

Americans with blood pressure of 130/80 or higher should be treated, down from the previous trigger of 140/90, according to new guidelines announced on Monday at the annual meeting of the American Heart Association in Anaheim, California.

At the new cutoff, around 46 percent, or more than 103 million, of American adults are considered to have high blood pressure, compared with an estimated 72 million under the previous guidelines in place since 2003.

High blood pressure accounts for the second-largest number of preventable heart disease and stroke deaths in the United States, second only to smoking.

The guidelines, also endorsed by the American College of Cardiology and 11 other organizations, do not change the definition of normal blood pressure as 120/80 or lower.

Potentially deadly high blood pressure can be brought under control with a wide array of medications, many sold as relatively inexpensive generics. The drug classes include angiotensin receptor blockers, such as Novartis AG’s Diovan, calcium channel blockers, like Pfizer Incs’s Norvasc, ACE inhibitors, including Pfizer’s Altace, and diuretics, such as Merck & Co Inc’s Hyzaar.

But the drugs have side effects and the new guidelines emphasize lifestyle changes including weight loss, diet and exercise as the first tool for combating hypertension.

“We see lifestyle modification as the cornerstone for treatment,” said Dr. Bob Carey, vice-chair of the guidelines committee and professor of medicine at the University of Virginia Health System School of Medicine.

Under the new threshold for initiating treatment, patients assessed to be at higher risk of cardiovascular problems will also be started on medication, he said.

A large, government-sponsored study of hypertension patients aged 50 and older showed in 2015 that death from heart-related causes fell 43 percent and heart failure rates dropped 38 percent when their systolic blood pressure was lowered below 120 versus those taken to a target of under 140.

But patients in the 120 systolic blood pressure group had a higher rate of kidney injury or failure, as well as fainting.

Concerns about those side effects, as well as the fact that the close monitoring seen in a clinical trial is hard to replicate, led the AHA, ACC and other groups to select the 130 systolic blood pressure target.

The new guidelines also emphasize the importance of accurate blood pressure measurements, using an average of different readings at different times.

Adults with blood pressure of 130/80 “already have double the risk of heart attack compared to someone in the normal range,” said Dr. Paul Whelton, professor at Tulane University School of Public Health and Tropical Medicine and School of Medicine in New Orleans and lead author of the new guidelines. “It doesn’t mean you need medication, but it’s a yellow light that you need to be lowering your blood pressure, mainly with non-drug approaches.”

(Reporting by Deena Beasley; Editing by James Dalgleish)

Chipotle denies link to ‘Supergirl’ actor’s illness

Cast member Jeremy Jordan attends the premiere of “The Last Five Years” in Los Angeles February 11, 2015. REUTERS/Phil McCarten

(Reuters) – Chipotle Mexican Grill Inc on Monday denied allegations by actor Jeremy Jordan that eating at one of its restaurants landed him in the hospital.

Jordan, who plays Winn Schott on TV show “Supergirl,” posted an Instagram video on Thursday of himself on a hospital bed, saying that food he ate at a Chipotle made him severely sick and that he “almost died,” according to a People.com report.

“There have been no other reported claims of illness at the restaurant where (Jordan) dined. We take all claims seriously, but we can’t confirm any link to Chipotle, given the details he shared with us,” Chipotle spokesman Chris Arnold said via email.

Chipotle is still recovering from a string of food safety lapses that started in late 2015, including a recent norovirus outbreak at a Virginia restaurant.

Jordan, through a spokesman, declined further comment.

The Denver-based burrito chain’s stock has fallen about 60 percent since an E. coli outbreak in 2015.

Shares of Chipotle fell as much as 6 percent to a near five-year low of $263.11 on Monday morning, but recouped most losses by afternoon. The stock closed down 0.7 percent.

(Reporting by Gayathree Ganesan and Uday Sampath Kumar in Bengaluru; additional reporting by Lisa Baertlein in Los Angeles; editing by Sai Sachin Ravikumar and Meredith Mazzilli)

Trump to tap ex-pharma executive Azar as health secretary

Alex Azar in an undated photo.
REUTERS/HHS

WASHINGTON (Reuters) – President Donald Trump on Monday said he will nominate former pharmaceutical executive Alex Azar to serve as U.S. Health and Human Services secretary, saying Azar would push to lower the price of medicines.

If confirmed, Azar also would take the lead in implementing Trump’s campaign promise to dismantle the Affordable Care Act, the 2010 healthcare overhaul passed under former Democratic President Barack Obama.

Trump, who is in the Philippines on a diplomatic trip, announced his intention to nominate Azar on Twitter by saying he would “be a star for better healthcare and lower drug prices.”

Azar worked at Eli Lilly <LLY.N> for a decade, including five years as president of its USA affiliate Lilly USA unit, and left the company in January, according to his LinkedIn page.

He also served several years on the board of directors of the Biotechnology Innovation Organization, a drug industry lobbying group, and earlier was general counsel and deputy secretary for Health and Human Services under former Republican President George W. Bush.

In February, Azar founded a consulting agency that specialized in biopharmaceutical and healthcare companies, his LinkedIn page said.

Azar’s nomination comes after Trump’s initial health secretary, former U.S. Representative Tom Price, resigned in September amid criticism over his use of expensive taxpayer-funded private charter jets for government travel instead of cheaper commercial flights.

Azar’s nomination must be approved by the U.S. Senate, which is controlled by Trump’s fellow Republicans. Democrats and other critics are likely to raise questions about the administration’s seriousness about lowering drug prices with a former industry executive leading such a charge.

(Reporting by Susan Heavey; Editing by Chizu Nomiyama and Bill Trott)

Bill Gates makes $100 million personal investment to fight Alzheimer’s

FILE PHOTO: Microsoft co-founder and philanthropist Bill Gates talks with a colleague before the Berkshire Hathaway annual meeting in Omaha, Nebraska, U.S. May 6, 2017. REUTERS/Rick Wilking/File Photo

By Kate Kelland, Health and Science Correspondent

LONDON, Nov 13 (Reuters) – Billionaire Microsoft co-founder Bill Gates is to invest $50 million in the Dementia Discovery Fund, a venture capital fund that brings together industry and government to seek treatments for the brain-wasting disease.

The investment – a personal one and not part of Gates’ philanthropic Bill & Melinda Gates Foundation – will be followed by another $50 million in start-up ventures working in Alzheimer’s research, Gates said.

With rapidly rising numbers of people suffering from Alzheimer’s and other forms of dementia, the disease is taking a growing emotional and financial toll as people live longer, Gates told Reuters in an interview.

“It’s a huge problem, a growing problem, and the scale of the tragedy – even for the people who stay alive – is very high,” he said.

Despite decades of scientific research, there is no treatment that can slow the progression of Alzheimer’s. Current drugs can do no more than ease some of the symptoms.

Gates said, however, that with focused and well-funded innovation, he’s “optimistic” treatments can be found, even if they might be more than a decade away.

“It’ll take probably 10 years before new theories are tried enough times to give them a high chance of success. So it’s very hard to hazard a guess (when an effective drug might be developed).

“I hope that in the next 10 years that we have some powerful drugs, but it’s possible that won’t be achieved.”

Dementia, of which Alzheimer’s is the most common form, affects close to 50 million people worldwide and is expected to affect more than 131 million by 2050, according to the non-profit campaign group Alzheimer’s Disease International.

The DDF, which was launched in 2015 and involves drugmakers GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer and Biogen Idec as well as the UK government, has already invested in at least nine start-up companies investigating potential ways to stop or reverse the biological processes that lead to dementia.

Gates told Reuters the additional $50 million would be put into start-ups working on some “less mainstream” approaches to the disease, but said he had not yet identified these companies.

The philanthropist, whose usual focus is on infectious diseases in poorer countries, said Alzheimer’s caught his interest partly for personal reasons, and partly because it has so far proved such a tough nut to crack.

“I know how awful it is to watch people you love struggle as the disease robs them of their mental capacity … It feels a lot like you’re experiencing a gradual death of the person that you knew,” he said in a blog post about the dementia investments.

“Some of the men in my family have suffered from Alzheimer’s, but I wouldn’t say that’s the sole reason” (for this investment),” he added.

Jeremy Hughes, chief executive of the Alzheimer’s Society charity, welcomed Gates’ “significant personal investment”, saying it would speed up progress toward a cure and help reduce stigma around dementia: “With Bill Gates now joining all those already united against dementia, there is new hope for advances in the care and cure of dementia,” he said in a statement.

Through talking to experts in the field over the past year, Gates said he had identified five areas of need: Understanding better how Alzheimer’s unfolds, detecting and diagnosing it earlier, pursuing multiple approaches to trying to halt the disease, making it easier for people to take part in clinical trials of potential new medicines, and using data better.

“My background at Microsoft and my (Gates) Foundation background say to me that a data-driven contribution might be an area where I can help add some value,” he said.

Alongside the $50 million investment in DDF and the additional $50 million planned for start-ups, Gates said he would like to award a grant to build a global dementia data platform. This would make it easier for researchers to look for patterns and identify new pathways for treatment, he said.

(Editing by Dan Grebler and Andrew Heavens)

U.S. top court to hear dispute over California pregnancy center law

An activist holds a rosary while ralling against abortion outside City Hall in Los Angeles, California September 29, 2015. REUTERS/Mario Anzuoni

By Lawrence Hurley

WASHINGTON (Reuters) – The U.S. Supreme Court on Monday agreed to decide whether a California law requiring private facilities that counsel pregnant women against abortion to post signs telling clients how to get state-funded abortions and contraceptives violates free speech rights.

The justices will hear an appeal brought by Christian-based non-profit facilities sometimes called “crisis pregnancy centers” of a lower court ruling that upheld the Democratic-backed 2015 California law. The challengers argue that the law, by forcing them to post the information, violates the U.S. Constitution’s First Amendment guarantee of free speech.

California argued that the Reproductive FACT Act, passed by a Democratic-led legislature and signed by Democratic Governor Jerry Brown, is justified by its responsibility to regulate the healthcare industry and is needed to ensure that women know the state has programs providing abortions and birth control.

The law requires licensed healthcare facilities to post a notice saying that the state has programs for “immediate free or low-cost access to comprehensive family planning services … prenatal care, and abortion for eligible women.” For non-licensed medical facilities, an additional notice is required stating that the center “has no licensed medical provider who provides or directly supervises the provision of services.”

The facilities had asked the high court to hear their appeal of a ruling last year by the San Francisco-based 9th U.S. Circuit Court of Appeals upholding the law.

In 2014, the U.S. Supreme Court declined to take up a challenge to similar law in New York City, although that case differed from the California dispute because the lower court had struck down several provisions, including one that required centers to disclose whether they provide abortions and other reproductive care.

The “crisis pregnancy centers” counsel women not to have abortions. These facilities, according to critics, often are located near hospitals and abortion clinics, offer ultrasounds and are staffed by people wearing medical garb. Some are medically licensed facilities, others are not.

Challengers included the National Institute of Family and Life Advocates, an umbrella group for anti-abortion pregnancy crisis centers that said its members include 73 centers in California that are medically licensed and 38 that are not.

The other plaintiffs are two centers in San Diego County: Pregnancy Care Center and Fallbrook Pregnancy Resource Center. The court did not act on three other cases brought by other centers making similar claims.

The Supreme Court found that women have a constitutional right to an abortion in the landmark 1973 case Roe v. Wade. The court most recently backed abortion rights in 2016 when it struck down a Texas law that imposed strict regulations on clinics that provided abortions.

(Reporting by Lawrence Hurley; Editing by Will Dunham)

Legionnaires sickens 12 in California, including 9 at Disneyland

By Dan Whitcomb

LOS ANGELES (Reuters) – Disneyland has shut down and decontaminated two cooling towers following an outbreak of Legionnaires disease that sickened 12 people, nine of them guests or employees at the theme park in Anaheim, county health officials said on Saturday.

One of the three cases of the respiratory illness not linked to Disneyland was fatal in an individual who had additional health issues, said Jessica Good of the Orange County Health Care Agency.

The chief medical officer for Walt Disney Parks and Resorts, Pamela Hymel, said in a written statement that after learning of the Legionnaires cases, park officials ordered the cooling towers treated with chemicals to destroy the bacteria and shut them down.

Cooling towers provide cold water for various uses at Disneyland and give off a vapor or mist that could have carried the Legionnella bacteria.

Disneyland, which opened in 1955 and attracts tens of thousands of visitors a day, is owned by The Walt Disney Company <DIS.N>.

Hymel said that local health officials had assured them that there was no longer any risk to guests or employees of the park.

There was no information on the condition of the remaining 11 victims, due to patient confidentiality laws.

Good said an investigation of Legionnaires cluster discovered that the 12 people sickened by the serious lung disease had traveled to, lived in, or worked in Anaheim during the month of September.

Ten of the victims, who ranged in age from 52 to 94, were hospitalized.

Legionnaires disease is caused by the Legionella bacteria and can cause potentially fatal respiratory illness and pneumonia. Older people and those with health issues are particularly at risk.

According to the Orange County health agency Legionella is becoming more common in the United States and in Orange County, where 55 cases have been reported through October 2017, compared with 53 for all of 2016 and 33 in 2015.

Symptoms develop 2 to 10 days after exposure, the OCHCA said, and include fever, chills, cough, muscle aches, and headaches. It is treated with antibiotics, which can improve symptoms and shorten the length of illness.

The disease is not contagious.

(Reporting by Dan Whitcomb; Editing by James Dalgleish)

Eurek-baa: Scientists find sheep can recognize human faces

A picture taken from undated video shows a sheep approaching a photo of Emma Watson during a Cambridge University experiment, in Cambridge, Britain. Jenny Morton/University of Cambridge handout via REUTERS

LONDON (Reuters) – Sheep have been trained to recognize the faces of celebrities, including former U.S. President Barack Obama, by University of Cambridge scientists who hope it may help with understanding neurodegenerative diseases.

In a specially equipped pen, sheep were shown pictures of people on two computer screens, on one side would be an unknown person and on the other would be one of four celebrities.

The animal would receive a reward of food for choosing the photograph of the celebrity by breaking an infrared beam near the screen displaying it. If they chose the wrong photograph, a buzzer would sound and they would receive no reward.

The sheep eventually managed to identify the familiar face eight times out of every 10.

The group of celebrities the sheep were trained to recognize included actors Emma Watson and Jake Gyllenhaal, BBC newsreader Fiona Bruce and Obama.

“We’ve shown that sheep have advanced face-recognition abilities, comparable with those of humans and monkeys,” Professor Jenny Morton, who led the study, said in a statement.

In addition to being shown images of the celebrities facing forward, scientists also tested the animals’ ability to recognize the faces in photographs taken from other angles.

The animals’ success rate fell by around 15 percent when presented with the faces at a new angle, an amount researchers said was comparable to that seen when humans perform the task.

Scientists aim to use the sheep as models to understand disorders of the brain, such as Huntington’s disease, that develop over a long time and affect cognitive abilities.

(Writing by Mark Hanrahan in London Editing by Jeremy Gaunt)

Fire trucks to spray Indian capital amid deepening smog emergency

A woman wearing a scarf to cover her face looks on as she waits for a passenger bus on a smoggy morning in New Delhi. REUTERS/Saumya Khandelwal

By Rupam Jain

NEW DELHI (Reuters) – India plans to use fire trucks to spray water over parts of its capital to combat toxic smog and dust that has triggered a pollution emergency, with conditions expected to worsen over the weekend.

Illegal crop burning in farm states surrounding New Delhi, vehicle exhausts and swirling construction dust have contributed to what has become an annual crisis.

Authorities will use the fire trucks in areas with high concentrations of toxic dust, said Ritesh Kumar Singh, an environment ministry official, after a meeting of civil servants from the city government and four neighboring states.

Another ministry official who did not wish to be identified said water cannon – usually used by police for riot control – would also be employed.

“Sprinkling water is the only way to bring down the dangerous pollution levels,” said Shruti Bhardwaj, an environmental official charged with monitoring air quality.

The thick blanket of grey air and pollutants has enveloped Delhi for four days. A U.S. embassy measure of tiny PM 2.5 particles, showed a reading of 523 at nine a.m. on Friday. The upper limit of “good” air is just 50.

PM 2.5 is about 30 times finer than a human hair. The particles can be inhaled deep into the lungs, causing heart attacks, strokes, cancer and respiratory diseases.

Delhi’s air has been consistently in the “hazardous” zone for days, despite measures such as a halt to construction and restrictions on car use including raising parking charges fourfold and a license plate “odd-even” rule on alternate days. Commercial trucks are banned from the city unless they are transporting essential commodities.

AIR PURIFIERS AND MASKS

Chief Minister Arvind Kejriwal, the leader of Delhi, has called the capital a “gas chamber”. Affluent residents and large companies have been placing bulk orders for air purifiers and masks.

“I have installed six air purifiers in my home and closed all the windows, but my eyes are still watering,” said Ranveer Singhal, a commodity trader living in a leafy neighborhood of the city.

Organizers of music festivals and open air parties canceled events after the Central Pollution Control Board said air quality could deteriorate further during the weekend.

Pronab Sarkar, president of the Indian Association of Tour Operators, said air pollution had also hit tourism.

The National Green Tribunal has directed the Delhi government and neighboring states to stop farmers from burning crop residue, but many have no choice, unable to afford machinery to clear fields instead.

The federal government said the states of Punjab and Rajasthan had failed to use funds allocated to them to help them in crop residue management and farm mechanization.

Punjab, known as India’s grain bowl, disputed the claims. A state government official said the funds were specifically meant for farm mechanization, not for stopping the burning of straw.

(Additional reporting by Manoj Kumar and Mayank Bhardwaj; Writing by Rupam Jain; Editing by Andrew Roche)

Novartis posts eye drug data amid play for Eylea’s turf

Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann

By John Miller

ZURICH (Reuters) – Novartis’s bid to move in on Bayer’s and Regeneron’s eye-drug turf was buoyed on Friday by data showing patients on the Swiss drugmaker’s new RTH258 drug showed less disease activity than those on its rivals’ drug Eylea.

Active disease was observed in 23.5 percent of RTH258 patients versus 33.5 percent of Eylea patients at 16 weeks, Novartis said, of its investigational treatment for wet age-related macular degeneration (AMD), where abnormal, leaky blood vessels can cause blindness.

A second, similar study found active disease in 21.9 percent of RTH258 patients versus 31.4 percent of those on Eylea for the condition affecting 20-25 million people worldwide.

Novartis in June touted initial data showing its drug may require fewer injections directly into the eye than Eylea, while matching it on vision and safety measures.

The Basel-based drugmaker hopes this latest analysis lends RTH258 additional muscle when matched head-to-head with Eylea as well as Lucentis, which Roche sells in the United States.

“When you take all of that together … we believe we have a very compelling proposition,” Vas Narasimhan, Novartis’s chief drug developer who will become CEO in 2018, said on a conference call.

Novartis, which released the data at the American Academy of Opthalmology conference in New Orleans, predicts RTH258 annual sales will top $1 billion and aims to file for U.S. approval in late 2018.

Making it a success is by no means clear sailing.

For one, Novartis owns Lucentis rights in Europe where it has contractual obligations to continue marketing that drug. Analysts say cannibalization from RTH258 will be a challenge.

Competition abounds, too: Eylea, with $5 billion in annual sales, has made inroads against the $3.2 billion-per-year Lucentis, whose 2020 U.S. patent expiration will expose it to cheaper copies.

Moreover, Roche’s cancer drug Avastin is effective in off-label AMD use and has won favor because it costs a fraction of Lucentis and Eylea. In Britain, Novartis and Bayer are fighting doctor groups aiming to switch to Avastin.

NEEDLE IN THE EYE

Other would-be rivals are racing to market, too.

Allergan, whose investigational Abicipar is in Phase III trials, is also trumpeting prospects of reduced injections compared to Lucentis. Gene therapies may also be on the distant horizon.

Still, Novartis’s Narasimhan remains optimistic for RTH258’s reception when it hits the market, likely in 2019.

“When you actually see an image of a patient having a needle inserted into their eye, this is something patients definitely want to avoid,” he said.

“Retinal surgeons have busy offices and want to do more complex retinal surgery. Today, they have offices filled with patients waiting for injections.”

(Reporting by John Miller; Editing by Adrian Croft)

Opioid abuse crisis takes heavy toll on U.S. veterans

FILE PHOTO: Needles used for shooting heroin and other opioids along with other paraphernalia litter the ground in a park in the Kensington section of Philadelphia, Pennsylvania, U.S. October 26, 2017. REUTERS/Charles Mostoller/File Photo

By Barbara Goldberg

NEW YORK (Reuters) – Opioid drug abuse has killed more Americans than the Iraq, Afghanistan and Vietnam wars combined, and U.S. veterans and advocates this Veteran’s Day are focusing on how to help victims of the crisis.

Veterans are twice as likely as non-veterans to die from accidental overdoses of the highly addictive painkillers, a rate that reflects high levels of chronic pain among vets, particularly those who served in the wars in Iraq and Afghanistan, according to federal data.

U.S. government and healthcare officials have been struggling to stem the epidemic of overdoses, which killed more than 64,000 Americans in the 12 months ending last January alone, a 21 percent increase over the previous year, according to the Centers for Disease Control. About 65,000 Americans died in Vietnam, Iraq and Afghanistan.

President Donald Trump named opioids a national public health emergency and a White House commission last week recommended establishing a nationwide system of drug courts and easier access to alternatives to opioids for people in pain.

“Our veterans deserve better than polished sound bites and empty promises,” said former Democratic Congressman Patrick Kennedy, a recovering addict and a member of the president’s opioid commission.

Kennedy said in an e-mail that more funding was needed for treatment facilities and medical professionals to help tackle the problem.

One effort to address the issue has stalled in Congress – the proposed Veterans Overmedication Prevention Act, sponsored by Senator John McCain. That measure is aimed at researching ways to help Veterans Administration doctors rely less on opioids in treating chronic pain.

“The Veterans Administration needs to understand whether overmedication of drugs, such as opioid pain-killers, is a contributing factor in suicide-related deaths,” McCain, one of the nation’s most visible veterans, said in an e-mail on Thursday. He noted that 20 veterans take their lives each day, a suicide rate 21 percent higher than for other U.S. adults.

The VA system has stepped up its efforts to address the crisis, having treated some 68,000 veterans for opioid addiction since March, said Department of Veterans Affairs spokesman Curtis Cashour.

The department’s Louis Stokes VA Center in Cleveland has also begun testing alternative treatments, including acupuncture and yoga, to reduce use of and dependency on the drugs, the VA said.

A delay in naming a Trump administration “drug czar” to head the effort, however, has fueled doubts about immediate action on the opioid crisis. Last month the White House nominee, Representative Tom Marino, withdrew from consideration following a report he spearheaded a bill that hurt the government’s ability to crack down on opioid makers.

(Reporting by Barbara Goldberg; Editing by Dan Grebler)

U.S. drug agency to toughen stance on illicit fentanyl analogues

FILE PHOTO: A used needle sits on the ground in a park in Lawrence, Massachusetts, U.S., May 30, 2017, where individuals were arrested earlier in the day during raids to break up heroin and fentanyl drug rings in the region, according to law enforcement officials. REUTERS/Brian Snyder/File Photo

By Sarah N. Lynch

WASHINGTON (Reuters) – The U.S. Drug Enforcement Administration said on Thursday that it would classify illicit versions of the synthetic opioid fentanyl at the same level as heroin, allowing criminal prosecution of anyone who possesses, distributes or manufactures illicit versions of the drug.

The action is the Justice Department’s latest effort to address the country’s opioid epidemic.

According to the U.S. Centers for Disease Control and Prevention, opioids were responsible for more than 33,000 U.S. deaths in 2015. Fentanyl is 50 times more potent than heroin and 100 times more potent than morphine.

Legally prescribed fentanyl is currently classified as a Schedule II drug, meaning it is highly addictive but has a medical purpose.

Naming illicit fentanyl as a Schedule 1 drug, along with heroin, means that is addictive and has no medicinal purpose.

Under the new DEA order, any new alternative chemical versions of fentanyl will be listed as Schedule 1 drugs, effectively making them illegal.

Many types of fentanyl analogues have made their way into communities across the United States in recent years, with many coming from China.

These drugs are chemically similar to fentanyl and have similar effects on the human body, but chemists tweak their molecular structure so that they fall outside of the DEA’s scheduling regime, thereby skirting the law.

To combat these chemical look-alikes, prosecutors have traditionally relied on the Federal Analogue Act. But the law presents some cumbersome challenges.

Although the government can prosecute people for making or selling analogues not listed on a DEA schedule, it needs to prove they are structurally similar to other scheduled drugs and have the same effects on the body.

The Justice Department has typically brought such cases in a piecemeal fashion, and each case has often entailed a battle among scientific expert witnesses about the chemical make-up of the drug or drugs at issue.

That approach has led to a “game of whack-a-mole,” one Justice Department official said on Thursday, because criminals are able to simply make another molecular tweak and concoct a new version of the drug that is not listed in the schedule.

The newly announced emergency scheduling of the fentanyl analogues is only temporary, but the DEA can take such a step if the public is facing an imminent safety threat.

It will last for two years, and potentially can be extended an additional year.

(Reporting by Sarah N. Lynch; Editing by Susan Thomas and Leslie Adler)

Large U.S. farm study finds no cancer link to Monsanto weedkiller

FILE PHOTO: Monsanto’s research farm is pictured near Carman, Manitoba, Canada August 3, 2017. REUTERS/Zachary Prong/File Photo

By Kate Kelland

LONDON, (Reuters) – A large long-term study on the use of the big-selling weedkiller glyphosate by agricultural workers in the United States has found no firm link between exposure to the pesticide and cancer, scientists said on Thursday.

Published in the Journal of the National Cancer Institute (JNCI), the study found there was no association between glyphosate, the main ingredient in Monsanto’s popular herbicide RoundUp, “and any solid tumors or lymphoid malignancies overall, including non-Hogkin Lymphoma (NHL) and its subtypes”.

It said there was “some evidence of increased risk of acute myeloid leukemia (AML) among the highest exposed group”, but added this association was “not statistically significant”.

The findings are likely to impact legal proceedings in the United States against Monsanto, in which more than 180 plaintiffs are claiming exposure to RoundUp gave them cancer – allegations that Monsanto denies.

The findings may also influence a crucial decision due by the end of the year on whether glyphosate should be re-licensed for sale across the European Union.

EU countries had been due to vote on the issue on Thursday, but again failed to agree to a proposal for a five-year extension.

The EU decision has been delayed for more than a year after the World Health Organization’s International Agency for Research on Cancer (IARC) reviewed glyphosate in 2015 and concluded it was “probably carcinogenic” to humans. Other bodies, such as the European Food Safety Authority, have concluded glyphosate is safe to use.

The research is part of a large and important project known as the Agricultural Health Study (AHS), which has been tracking the health of tens of thousands of agricultural workers, farmers and their families in Iowa and North Carolina.

Since the early 1990s, it has gathered and analyzed detailed information on the health of participants and their families, and their use of pesticides, including glyphosate.

David Spiegelhalter, a professor of the Public Understanding of Risk at Britain’s Cambridge University who has no link to the research, said Thursday’s findings were from a “large and careful study” and showed “no significant relationship between glyphosate use and any cancer”.

He added that the possible association with AML “is no more than one would expect by chance” and was not a concern.

Reuters reported in June how an influential scientist was aware of new AHS data while he was chairing a panel of experts reviewing evidence on glyphosate for the International Agency for Research on Cancer (IARC) in early 2015.

But since it had not at that time been published, he did not tell the expert panel about it and IARC’s review did not take it into account.

The publication of the study on Thursday comes more than four years since drafts based on the AHS data on glyphosate and other pesticides were circulating in February and March 2013.

In a summary of the results, the researchers, led by Laura Beane Freeman, principal investigator of the AHS at the U.S. National Cancer Institute, said that among 54,251 (pesticide) applicators studied, 44,932, or 82.9 percent, used glyphosate.

“Glyphosate was not statistically significantly associated with cancer at any site,” the summary said.

Scott Partridge, Monsanto’s vice president of strategy, said the study results clearly showed the weedkiller was safe.

“This is the largest study of agricultural workers in history, over the longest period of time,” he told Reuters. “It is the gold standard,… and it definitively demonstrates in a real-world environment that glyphosate doesn’t cause cancer.”

(Reporting by Kate Kelland, Editing by Gareth Jones)

Amid Trump cuts, Uber kicks off campaign to enroll drivers in Obamacare

FILE PHOTO: An Uber sign is seen in a car in New York, U.S. June 30, 2015. REUTERS/Eduardo Munoz/File Photo

By Salvador Rodriguez

SAN FRANCISCO (Reuters) – Uber Technologies Inc [UBER.UL] and some smaller technology companies are launching campaigns to publicize Obamacare enrollment among their contract workers after the Trump administration slashed government marketing for the health program by 90 percent.

Freelance and contract workers are an important part of the workforce for many Silicon Valley companies, including drivers at Uber and rival Lyft Inc, and technology companies also have been among the most vocal in confronting Trump administration policies – particularly immigration – that they perceive as hurting their workforce.

Uber describes its program as a response to a growing need for drivers rather than a political act. The program is part of an effort started in June by Uber to improve the company’s relationship with drivers by rolling out new initiatives and features, such as tipping, that better serve them.

Starting on Friday, Uber will hold events for drivers in 28 U.S. cities, from Los Angeles to Indianapolis, to offer in-person assistance in signing up for insurance plans offered through the Affordable Care Act, commonly known as Obamacare. Uber did not disclose a budget for the initiative.

The Uber program is an expansion of a partnership with Stride Health, a health consultant startup that specializes in helping independent workers choose health, dental and vision insurance plans. Stride said it is also working separately with a group of companies, including Etsy Inc <ETSY.O>, DoorDash Inc and Postmates Inc, to sign up independent contractors for insurance.

Uber has had a difficult year in the face of a federal probe into whether it broke bribery laws, allegations of sexual harassment, and other issues that led the company to bring in a new chief executive and promise to take better care of drivers.

Former CEO Travis Kalanick also drew criticism for joining President Donald Trump’s business advisory council. Kalanick left the council in February.

Across the United States, Obamacare enrollment for 2018 is clouded by uncertainty as experts expect reduced participation amid bitter political debate around the program’s future.

Republicans in Congress have repeatedly failed to repeal and replace former President Barack Obama’s healthcare law, which they have said drives up costs for consumers and interferes with personal medical decisions. Democrats have warned that repeal would leave millions of Americans without health coverage.

Meghan Joyce, regional general manager of the United States and Canada for Uber, said in a phone interview this week that there was an appetite for healthcare among drivers. Nearly 150,000 Uber drivers enrolled for insurance plans through Stride Health last year. “This year we’re doubling down on that,” Joyce said.

The Trump administration has shortened the Affordable Care Act enrollment period, which is currently open. It also has cut the advertising budget to $10 million and slashed by 40 percent the budget for support staff, known as navigators, who help people choose policies.

“Those are gone in most parts of the country,” said Stride Health Chief Executive Noah Lang in a phone interview on Friday.

The enrollment period ends on Dec. 15. in most states.

“There’s independent contractors who need coverage right now. The law of the land says they have access to it. It’s our No. 1 job to make sure they get it,” Lang said.

(Reporting by Salvador Rodriguez; Editing by Peter Henderson and Matthew Lewis)

Maine governor will not expand Medicaid, ignoring voters

FILE PHOTO — Maine Governor Paul LePage speaks at the 23rd Annual Energy Trade & Technology Conference in Boston, Massachusetts, November 13, 2015. REUTERS/Gretchen Ertl/File Photo

By Gina Cherelus

(Reuters) – Maine Republican Governor Paul LePage said on Wednesday he will not expand the state’s Medicaid program under Obamacare, ignoring a ballot initiative widely backed by voters, calling it “ruinous” for the state’s budget.

Maine looked set to become the first state in the nation to expand Medicaid by popular vote.

About 60 percent of voters in Maine approved the ballot proposal in Tuesday’s election, according to the Bangor Daily News newspaper.

Republicans in Washington have failed several times to pass legislation that would dismantle former President Barack Obama’s signature healthcare law.

LePage said he will not implement the expansion until it is fully funded by the Maine legislature.

“Credit agencies are predicting that this fiscally irresponsible Medicaid expansion will be ruinous to Maine’s budget,” LePage said in a statement. “I will not support increasing taxes on Maine families, raiding the rainy day fund or reducing services to our elderly or disabled.”

LePage said a previous Medicaid expansion in Maine in 2002 had created $750 million in debt to hospitals and took resources away from vulnerable people.

Maine has been prominent in the nation’s healthcare debate. U.S. Senator Susan Collins, a moderate Republican from Maine, helped block her party’s efforts to repeal Obamacare. Collins did not immediately respond to a request for comment on LePage’s decision.

Maine voters were asked to approve or reject a plan to provide healthcare coverage under Medicaid for adults under age 65 with incomes at or below 138 percent of the federal poverty level, which in 2017 is about $16,000 for a single person and about $22,000 for a family of two.

If implemented, about 70,000 additional state residents would be eligible for the Medicaid program, local media reported, in addition to the roughly 268,000 people who are currently eligible.

(Reporting by Gina Cherelus in New York; Editing by Daniel Wallis and Jeffrey Benkoe)

CBO revises deficit estimate from Obamacare individual mandate repeal

FILE PHOTO: A sign on an insurance store advertises Obamacare in San Ysidro, San Diego, California, U.S., October 26, 2017. REUTERS/Mike Blake/File Photo

WASHINGTON (Reuters) – The Congressional Budget Office on Wednesday said that repealing the individual mandate for health insurance would reduce the federal budget deficit less than first forecast as it readied a revised analysis of a policy shift favored by Republicans.

The CBO, the nonpartisan budget-scoring agency, said in a statement on its website that eliminating the mandate in the Affordable Care Act, also often dubbed Obamacare, would lower the deficit by $338 billion over the next decade, not $416 billion, its previous estimate.

It will release a fuller revised analysis conducted with the congressional Joint Committee on Taxation later on Wednesday that will also estimate the impact on health insurance coverage and premiums.

“The agencies are in the process of revising their methods to estimate the repeal of the individual mandate,” the CBO said, adding that work on updating the methodology was not yet complete.

The Obamacare mandate requiring Americans to buy health insurance has proved to be among the most controversial portions of the law.

Some Republicans want to include a repeal of the mandate in legislation to reform the tax code. The U.S. House of Representatives unveiled its tax plan last week, and the Senate’s plan is expected to be released on Thursday.

(Reporting by Makini Brice; Editing by Susan Heavey and Jeffrey Benkoe)

U.S. senators press Allergan for details on patent deal with tribe

FILE PHOTO: A sign marks Allergan’s offices in Medford, Massachusetts, U.S., July 31, 2017. REUTERS/Brian Snyder/File Photo

By Jan Wolfe

(Reuters) – A group of U.S. senators on Tuesday asked drugmaker Allergan Plc to produce documents relating to its agreement to transfer patents to a Native American tribe to shield them from review by an administrative court.

Democratic Senators Sherrod Brown, Maggie Hassan, Amy Klobuchar, Al Franken and Patty Murray made the request for documents in a letter to Allergan Chief Executive Brent Saunders.

The letter was critical of Allergan’s deal with New York’s Saint Regis Mohawk Tribe, saying “it is difficult to conceive of Allergan’s transaction as anything other than a sham to subvert the existing intellectual property system.”

Allergan contends the tribe’s status as a sovereign entity places the patents outside the jurisdiction of the U.S. Patent Trial and Appeal Board, or PTAB.

Allergan on Sept. 8 transferred patents on its dry eye medication Restasis to the tribe, which agreed to license them exclusively back to the company in exchange for ongoing payments. A federal court invalidated Allergan’s Restasis patents on Oct. 16, rendering the tribal deal mostly meaningless. Allergan has appealed that ruling.

In Tuesday’s letter, the senators said they were concerned that tribes could reach similar deals with other manufacturers of brand-name prescription drugs.

They asked Allergan to disclose the terms of its agreement with the tribe and explain whether it has plans for similar patent transactions.

The lawmakers also demanded to see “any legal briefs or memos prepared by Allergan regarding sovereign immunity,” particularly memos on the question of whether Allergan’s agreement could immunize patents from review by federal courts.

The lawmakers gave Allergan a December 1 deadline to produce the requested documents.

A bipartisan group of representatives from the House Oversight and Government Committee made a similar request for documents from Allergan in October.

Allergan spokesman Mark Marmur said the company welcomes the opportunity to continue to brief lawmakers about the deal.

Marmur also defended Allergan’s bid to avoid PTAB review, saying “experts across the legal, biopharmaceutical and business communities” have raised concerns about the fairness of the administrative process.

Allergan has said it does not object to its patents being reviewed in federal court, which it called a fair and time-tested process.

(Reporting by Jan Wolfe in New York; Editing by Dan Grebler)

The battle for minds: Britain expands project on mental health in terrorism

FILE PHOTO: Police officers and forensics investigators and police officers work on Westminster Bridge the morning after an attack by a man driving a car and weilding a knife left five people dead and dozens injured, in London, Britain, March 23, 2017. REUTERS/Darren Staples/File Photo

By Michael Holden

LONDON (Reuters) – A project looking at links between mental health and terrorism in three English cities has been expanded nationwide after it found a significant number of people referred to counter-radicalization programs suffer some form of mental illness.

Studies have suggested the prevalence of mental health issues among militants working together on major strikes is very low but a string of killings by so-called lone wolves has fueled concerns mental illness could be a factor behind some attacks.

Authorities say some of those involved in four attacks in Britain this year blamed on Islamist militants appeared to people who had self-radicalized via the internet and whose mental state had been questioned.

To look more closely at the issue, British police launched pilot programs in April last year in England’s three biggest urban areas – London, Birmingham and Manchester – to embed mental health experts with counter-terrorism officers.

The aim was to give psychiatrists the chance to identify people referred to Britain’s counter-radicalization program Prevent who had mental health issues, and treat them.

“Anecdotally, I am surprised that there appears to be a much higher prevalence of people with mental health problems than you would expect,” said Professor Jennifer Shaw, the mental health lead for Greater Manchester Police, referring to the people her team had dealt with since the pilot was launched.

The hubs are considered so successful by the government they have been expanded nationwide, Shaw, professor of forensic psychiatry at the University of Manchester, told Reuters.

But such is the secrecy around the work of Prevent and Channel – a de-radicalization program within the overall project – there are few details about its successes or failings and Shaw’s work has not previously been discussed in the media.

Some psychiatrists argue that no scientific link between mental health issues and terrorist attacks has yet been established and they worry the programs risk stigmatizing people suffering from mental illnesses.

Another psychiatrist gathering data under the pilot programs told Reuters that Britain’s Office for Security and Counter-Terrorism had told them not to disclose any details of their findings ahead of a final report.

Those findings are expected to be among a raft of data about people referred to Prevent due to be released this week.

Britain’s interior ministry did not respond to requests for comment.

‘WE WANT THE FACTS’

Dr Adrian James, registrar at Britain’s Royal College of Psychiatrists (RCP), said the link between mental health problems and terrorist acts had not been established.

He said a lack of evidence, partly because militant attacks were so rare, was at the heart of the problem, adding that an unnecessary level of secrecy about Prevent also meant many psychiatrists viewed the program with suspicion.

“If it is true that there is a link, we need to know and then need to look at the causes of that and what we can do about them,” James told Reuters. “We just want the facts.”

Past studies have disagreed about the significance of mental health issues among lone wolf attackers, with some academics concluding that such illnesses are blamed to try to explain often complex reasons for attacks.

British police decided to launch the pilot programs because they believed that roughly half the 7,500 people referred to Prevent each year had a broad range of mental health and psychological difficulties.

Those working on the pilot projects hope the information being gathered will now help experts assess any possible links between mental health issues and attacks.

Shaw said determining who might be a potential attacker from mental health problems alone was not really feasible and fraught with problems, but she said it might be possible to ascertain the characteristics of people most likely to be at risk and ensure they got appropriate help.

“That doesn’t mean you can’t manage the risks. Trying to nip it in the bud, that’s all you can do. But that’s good if you can achieve that, it’s going a long way,” said Shaw.

Police officers say they have struggled in the past to reach medical practitioners when they had concerns about some people and Shaw said the pilot was designed to address those worries.

According to one of Shaw’s case studies, a man went to a hospital saying he monitored Islamic State websites, had been walking around the city center working out how many people he could kill in a gun attack, and wanted to behead his mother.

Shaw’s team discovered the man had no contact with mental health services and no diagnosis of any illness. An urgent assessment concluded his anger stemmed from experiences in his childhood and safeguarding measures were put in place.

‘TERRORIST METHODOLOGY’

British police have no doubts about the importance of the work, especially given the global shift from carefully planned spectacular attacks by militant networks to unsophisticated, strikes by individuals using cars and knives as weapons.

Mark Rowley, Britain’s most senior counter-terrorism officer, told the British Medical Journal in April that a disproportionate number of suspects in 13 attacks foiled by British police since 2013 had mental health issues.

“If part of the terrorist methodology is to prey on the vulnerable … then it stands to reason that there will be people with certain mental health conditions who will be … susceptible to that,” he said.

“Radicalizing and inciting someone who is vulnerable to go and carry out some ghastly attack seems to be part of their tactics, and that has brought in a whole load of vulnerability issues, including mental health, that we now have to wrestle with,” said Rowley.

A study by University College London’s (UCL) Department of Security and Crime Science looked at 55 attacks involving 76 individuals between May 2014 and September 2016 where reports had shown the perpetrators may have been influenced by IS.

The study found 34 percent of those involved in attacks inspired by Islamic State – rather than actually directed by the militant group – had mental health issues.

Health experts estimate about one in four people will suffer some form of mental health issue and those with mental illnesses are generally less likely to commit violent crimes than the overall population.

STIGMATIZATION CONCERNS

Shaw said those with mental health issues and developmental disorders referred to her team at Prevent were more likely to be suffering from psychosis and autism, adding that people with serious mental illnesses often had tiny social networks.

“They can therefore, when unwell, be influenced by messages that go out that say come and belong to our group. It can be quite compelling. The same for people with autism. The internet kind of way of getting the message out makes those people, particularly vulnerable. So I think that’s a big issue.”

Psychiatrists worry that all people with mental health issues could be stigmatized and considered potential militants, possibly deterring them from seeking help.

Prevent, one of the four strands of Britain’s counter-terrorism strategy known as Contest launched in 2003, has also been dogged by claims it is used to spy on Muslim communities.

A government edict in 2015 instructing public bodies such as schools, health workers and universities to raise any concerns they have about individuals with the authorities has exacerbated those concerns.

Shaw acknowledged more work was needed on the outcomes of their mental health interventions under the Prevent pilot programs to determine what made a difference.

Asked if people her team had treated might have committed violent acts if their conditions had not been addressed, she said: “That is the obvious question. You can’t say that in any kind of scientific way.

“We’re attempting to try and get at that. Is it completely to do with their mental illness, half to do with it, or not at all?” said Shaw.

“We have had cases where people have had ideologies, they have also had a mental health problem, and they are not linked at all. The last thing we need is ‘all these bombers are nutters’. We don’t want that going on.”

(Editing by David Clarke)

Massachusetts court to weigh universities’ suicide prevention role

FILE PHOTO: A man walks through Killian Court at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts, U.S. May 13, 2016. REUTERS/Brian Snyder/File Photo

By Nate Raymond

BOSTON (Reuters) – The top court in Massachusetts is expected to hear arguments on Tuesday in a closely watched lawsuit against the Massachusetts Institute of Technology questioning to what extent universities and colleges can be held responsible when students commit suicide.

The Massachusetts Supreme Judicial Court will weigh whether to revive a lawsuit by the father of Han Nguyen, a PhD candidate who at the age of 25 jumped to his death from the top of a building on the prestigious university’s campus in 2009.

The lawsuit has drawn the interest of other Massachusetts schools, including Harvard University and Tufts University, which say a ruling against MIT would unreasonably require non-clinical faculty and staff to secure students against harming themselves.

The 18 schools said in a brief that such a requirement could expose them to discrimination lawsuits if they exclude such a student from a program to prevent harm and would have a “chilling effect on students with mental health conditions and other concerns.”

In court papers, a lawyer for Nguyen’s father contends that MIT and its employees owed a duty of care to Nguyen, whose mental health status was declining, yet officials at the school did nothing despite knowing he was a suicide risk.

The lawyer, Jeffrey Beeler, argues that MIT faculty and employees were well-aware of the risk of suicide among its students generally and foresaw the possibility that Nguyen would take his own life, but did nothing to ensure he got help.

As early as 2008, faculty members warned of his suicide risk while deciding to modify his exams, the lawyer said. Four months before Nguyen died, a professor recommended colleagues avoid failing him because they might have “blood on their hands.”

The day he died, that professor “read him the riot act” over an email Nguyen sent another professor expressing concerns about a possible position for him after he lost out on another school’s summer program, Beeler said in court papers.

MIT urged the court to uphold a lower-court judge’s decision to dismiss the case, saying a ruling against it would transform the relationship between faculty and their students and impose unreasonable demands on non-clinicians.

In a statement, MIT said regardless of the legal issues before the court, it “remains committed to the wellbeing of its students, offering a robust network of support resources, including comprehensive mental health services.”

(Reporting by Nate Raymond in Boston; Editing by Dan Grebler)

Insurers step up pitch for Obamacare as government slashes its effort

FILE PHOTO: A sign on an insurance store advertises Obamacare in San Ysidro, San Diego, California, U.S., October 26, 2017. REUTERS/Mike Blake/File Photo

By Caroline Humer

NEW YORK (Reuters) – President Donald Trump’s 90 percent cut to Obamacare advertising has U.S. health insurers in many states digging deeper into their pockets to get the word out about 2018 enrollment, which opened last week.

Independence Blue Cross, a health insurer in Pennsylvania, has commissioned a tractor trailer truck to bring insurance consultants out to shopping centers and other neighborhood spots around Philadelphia.

Centene Corp <CNC.N>, best known for its Medicaid health insurance, is expanding TV and print advertising for Obamacare as it ventures into three new states: Kansas, Missouri and Nevada. Tech-savvy newcomer Oscar Health has four different TV commercials running in six states including Texas and Ohio that espouse “easy health insurance” with video shots of patients text-messaging with Oscar.

Trump cut $90 million in advertising and outreach spending for the 2018 enrollment period, which opened on Nov. 1, part of his promise to let Democratic President Barack Obama’s signature healthcare law “implode” until Congress can repeal it.

Republicans say the Affordable Care Act, the law that created Obamacare, drives up costs for consumers, while Democrats warn that millions of Americans will be left without healthcare if it is dismantled.

The advertising serves two roles: It helps draw in the young, healthy customers who keep overall member costs down and it addresses confusion among many people over whether the subsidies that help make coverage affordable to many and Obamacare itself still exist in the wake of Trump’s actions.

The government’s advertising budget is now just $10 million for the 39 states that rely on the federal Healthcare.gov website to enroll consumers. The 11 states that run their own exchanges, like California and New York, set their own advertising budgets.

“Our member plans are generally ramping up their efforts to kind of plug that hole,” said Kelley Turek, an executive policy director at industry lobbyist America’s Health Insurance Plans. “A decrease of $90 million is a big hole to plug.”

News headlines about changes in the government’s support of Obamacare and Trump’s tweets have raised fears that all program subsidies are ending. The government has also cut the enrollment period in half, to six weeks. (http://tmsnrt.rs/2k1HAlV)

Adding to the confusion, insurers like Anthem Inc <ANTM.N> have sharply raised monthly premiums on the most popular Obamacare plans to account for reduced government funding, or pulled out of dozens of U.S. counties. As a result, many Obamacare customers may need to change health plans for 2018, either to work with a different insurer or in response to price increases.

“I still run into people who are wondering, am I still going to have a plan next year?” Independence Blue Cross Chief Executive Officer Daniel Hilferty said in an interview.

Hilferty said the company is increasing its advertising this year in part because of that confusion.

IMBALANCED MARKET

In September, the Congressional Budget Office said it expected 2018 enrollment to reach 11 million people versus about 10 million this year. It cut its previous projection by 4 million as Trump threatened the law and later cut the estimated $10 billion in government subsidies to insurers to cover customer out-of-pocket costs in 2018.

To make up for the reduced subsidies, which apply to the most common “silver” plans – the middle tier of the plans offered – insurers raised premiums by about 20 percent on those plans.

Others say total sign-ups will drop. Get America Covered, an outreach group founded by former Obama administration officials, predicts 1.1 million fewer people will sign up during the enrollment period. Lori Lodes, a co-founder of the group, said the effort by insurers focused on local markets could not match the impact of a national campaign.

Various insurers say they are trying.

Blue Cross Blue Shield of North Dakota, the sole Obamacare insurer in most of North Dakota, increased online advertising for 2018, while traditional TV and radio advertising remained about flat, spokeswoman Andrea Dinneen said.

Florida Blue, which has about 1 million members in Obamacare plans throughout Florida, is increasing its grass roots efforts this year. It has hired 700 temporary employees to help with enrollment and is planning to take part in more than 1,000 enrollment events, such as county fairs or educational sessions, spokesman Paul Kluding said.

On the other hand, Blue Cross Blue Shield of Michigan said it would spend less on wooing customers because of the financial pressures from the lowered subsidies, which went into effect this month. Instead it will focus on helping existing customers select plans that may keep premium costs down, rather than automatically re-enrolling in the silver plans.

“We decided to try to be as lean as possible,” said Rick Notter, director of the individual business.

(Reporting by Caroline Humer; Editing by Michele Gershberg and Leslie Adler)

Valeant to sell female libido pill business back to former owners

FILE PHOTO: A sign for the headquarters of Valeant Pharmaceuticals International Inc is seen in Laval, Quebec June 14, 2016. REUTERS/Christinne Muschi/File Photo

(Reuters) – Valeant Pharmaceuticals International Inc <VRX.TO> <VRX.N> said on Monday it will sell its female libido-pill business Sprout Pharmaceuticals back to its former owners, two years after buying the company for about $1 billion.

Addyi, the controversial pink pill made by Sprout, was touted as a possible blockbuster drug that would command much of what analysts had said could be a $2 billion market.

But sales of the pill has been sluggish and last year Valeant was sued on behalf of former Sprout investors over its alleged failure to market Addyi successfully.

The complaint had said that sales of the pill may have totaled less than $10 million in 2016, far short of the $1 billion targeted by July, 2017.

Approved by the U.S. Food and Drug Administration in August 2015 under intense pressure from patient advocacy groups, Addyi is meant to activate sexual impulses in the brain and is taken daily.

But it carries a strong warning about potentially dangerous low blood pressure and fainting, especially when taken with alcohol.

Valeant said on Monday it would get 6 percent royalty on global sales of Addyi beginning 18 months from the signing of the deal, which is expected to close before the end of the year.

Valeant said it will provide a $25 million loan to fund initial operating expenses.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Sayantani Ghosh)

Bayer in bid to broaden use of anti-clotting drug Xarelto

The logo of Bayer AG is pictured at the Bayer Healthcare subgroup production plant in Wuppertal, Germany February 24, 2014. REUTERS/Ina Fassbender/File Photo

By Ludwig Burger

FRANKFURT (Reuters) – German drugmaker Bayer on Monday moved to tap a potentially lucrative new market opportunity for its blockbuster clot prevention drug Xarelto, requesting approval in Europe to make atherosclerosis patients eligible for treatment.

Xarelto is already approved for a number of cardiovascular conditions and prevention of strokes caused by atrial fibrillation, a type of irregular heart beat common among the elderly, is the main profit driver.

The drug, in which partner Johnson & Johnson holds U.S. marketing rights, was earlier this year shown to cut the risk of potentially deadly strokes and heart attacks in patients with severe atherosclerosis by 24 percent, raising the prospects of billions more in sales.

Bayer, which is buying U.S. seed maker Monsanto, has said about 30 million additional patients could potentially benefit from the drug, once regulators give their go-ahead for the atherosclerosis indication.

That would come on top of a population of roughly 25 million patients in atrial fibrillation.

In the irregular heart beat market, Xarelto is head to head with rival pill Eliquis, owned by Pfizer and Bristol-Myers Squibb, and also competes with Boehringer Ingelheim’s Pradaxa, but none of them has been tested in the atherosclerosis setting.

The EU filing covers patients suffering coronary artery disease (CAD) or peripheral artery disease (PAD), which are common forms of gradually constricting arteries in the legs, neck and around the heart. They are typically given much cheaper aspirin to prevent cardiovascular knock-on diseases.

(Reporting by Ludwig Burger)

U.S. House approves funding for children’s healthcare program

FILE PHOTO: A pregnant woman stands on a scale before receiving a prenatal exam at the Maternity Outreach Mobile in Phoenix, Arizona October 8, 2009. REUTERS/Joshua Lott

By Susan Cornwell

WASHINGTON (Reuters) – The U.S. House of Representatives on Friday approved legislation to continue a federal insurance program for millions of lower-income children and pregnant women, but with an ongoing funding battle it could be weeks before the program gets more money.

The House Republican measure was approved 242-174 largely along party lines. It would continue the Children’s Health Insurance Program (CHIP) for five years. But Democrats warned the partisan House approach would not fly in the Senate, further delaying cash for the program that expired over a month ago.

“This bill is going nowhere … the Senate will not take it up, and we will be waiting around until Christmas” to get funding, Democratic Representative Frank Pallone warned. Republicans control 52 of the Senate’s 100 seats, and 60 votes are needed for passage there.

CHIP, which provides health insurance to about 9 million children, has been a bipartisan program since its creation 20 years ago and reauthorizing funding has not been contentious – until now.

Under President Donald Trump and a Republican-controlled Congress, healthcare issues have become highly politicized as Republicans have repeatedly failed to repeal and replace Obamacare, a top Trump campaign promise.

The program’s funding lapsed on Sept. 30, but most states have enough money to continue it past 2017. Still, 11 states, including Colorado, California, Utah, Ohio and Pennsylvania expect to exhaust their funding by the end of the year, according to the Kaiser Family Foundation.

Another 21 states anticipate running out of money by the end of March 2018.

The House bill extends the program for five years, and continues funding of community health centers for two years. It also includes $1 billion for Medicaid programs in Puerto Rico and the Virgin Islands, hard hit by recent hurricanes.

The bill became controversial after Republicans added provisions that would affect the Affordable Care Act, former Democratic President Barack Obama’s signature domestic policy achievement.

They include slashing funding from the law’s Prevention and Public Health Fund, which among other things helps fight the opioid epidemic, and making it easier to kick people off Obamacare plans for non-payment of premiums.

However, Republican Representative Greg Walden pointed out the bill would block for two years the Medicaid cuts for hospitals that would otherwise occur under Obamacare.

Democrats criticized the legislation for asking Medicare’s wealthiest one percent of beneficiaries, those who make more than $40,000 each month, to pay more to help fund health insurance for low-income children.

(Reporting by Susan Cornwell; Additional reporting by Yasmeen Abutaleb; Editing by Jeffrey Benkoe)

U.S. House approves funding for children’s healthcare program

FILE PHOTO: A pregnant woman stands on a scale before receiving a prenatal exam at the Maternity Outreach Mobile in Phoenix, Arizona October 8, 2009. REUTERS/Joshua Lott

By Susan Cornwell

WASHINGTON (Reuters) – The U.S. House of Representatives on Friday approved legislation to continue a federal insurance program for millions of lower-income children and pregnant women, but with an ongoing funding battle it could be weeks before the program gets more money.

The House Republican measure was approved 242-174 largely along party lines. It would continue the Children’s Health Insurance Program (CHIP) for five years. But Democrats warned the partisan House approach would not fly in the Senate, further delaying cash for the program that expired over a month ago.

“This bill is going nowhere … the Senate will not take it up, and we will be waiting around until Christmas” to get funding, Democratic Representative Frank Pallone warned. Republicans control 52 of the Senate’s 100 seats, and 60 votes are needed for passage there.

CHIP, which provides health insurance to about 9 million children, has been a bipartisan program since its creation 20 years ago and reauthorizing funding has not been contentious – until now.

Under President Donald Trump and a Republican-controlled Congress, healthcare issues have become highly politicized as Republicans have repeatedly failed to repeal and replace Obamacare, a top Trump campaign promise.

The program’s funding lapsed on Sept. 30, but most states have enough money to continue it past 2017. Still, 11 states, including Colorado, California, Utah, Ohio and Pennsylvania expect to exhaust their funding by the end of the year, according to the Kaiser Family Foundation.

Another 21 states anticipate running out of money by the end of March 2018.

The House bill extends the program for five years, and continues funding of community health centers for two years. It also includes $1 billion for Medicaid programs in Puerto Rico and the Virgin Islands, hard hit by recent hurricanes.

The bill became controversial after Republicans added provisions that would affect the Affordable Care Act, former Democratic President Barack Obama’s signature domestic policy achievement.

They include slashing funding from the law’s Prevention and Public Health Fund, which among other things helps fight the opioid epidemic, and making it easier to kick people off Obamacare plans for non-payment of premiums.

However, Republican Representative Greg Walden pointed out the bill would block for two years the Medicaid cuts for hospitals that would otherwise occur under Obamacare.

Democrats criticized the legislation for asking Medicare’s wealthiest one percent of beneficiaries, those who make more than $40,000 each month, to pay more to help fund health insurance for low-income children.

(Reporting by Susan Cornwell; Additional reporting by Yasmeen Abutaleb; Editing by Jeffrey Benkoe)

China disputes Trump’s claims of fentanyl ‘flood’ into United States

U.S. President Donald Trump speaks about administration plans to combat the nation’s opioid crisis in the East Room of the White House in Washington, U.S., October 26, 2017. REUTERS/Kevin Lamarque

By Philip Wen

BEIJING (Reuters) – China’s drug control agency disputed on Friday U.S. President Donald Trump’s claim that most of the synthetic drug fentanyl at the heart of the U.S. opioid crisis was produced in China.

Declaring the crisis a public health emergency, U.S. President Donald Trump said last week he would discuss as a “top priority” stopping the “flood of cheap and deadly” fentanyl “manufactured in China” when he meets President Xi Jinping during his state visit to Beijing next week.

Wei Xiaojun, the deputy secretary-general of China’s National Narcotics Commission, said China did not “deny or reject” that some fentanyl produced in China had made its way to the United States.

But the “intelligence and information exchanged between China and the United States is not enough to say that most of the fentanyl or other opioid substances originate from China”, Wei said at a joint news briefing with the U.S. Drug Enforcement Administration (DEA) in Beijing.

Opioids include prescription painkillers, heroin and fentanyl, a highly addictive synthetic drug 50 to 100 times more potent than morphine.

The Centers for Disease Control estimated that 20,000 Americans were killed by fentanyl last year, surpassing common painkillers and heroin for the first time.

American law enforcement agencies and drug control experts say most of the fentanyl distributed in the United States, as well as precursor chemicals, originate from China.

While Chinese officials dispute these claims, Beijing has taken steps to crack down on the production and export of synthetic drugs, and has placed fentanyl and 22 other related compounds on its list of controlled substances.

It had done so even though fentanyl was not widely abused in China, Wei said, primarily in the spirit of cooperating with the United States and the broader international community.

China and the United States have increased cooperation on drug control in recent years and are holding a bilateral meeting on the issue this week. The DEA opened its second country office in southern Guangzhou in January.

Lance Ho, who heads the DEA’s Country Office in Beijing, said the cooperation between the two countries had generated good “momentum” and was focused on improving the real-time sharing of information.

“Once China controls a substance it has a dramatic effect on the United States in terms of lives saved,” Ho said.

The U.S. Department of Justice indicted two major Chinese drug traffickers last month on charges of making illegal versions of fentanyl and selling the highly addictive drug to Americans over the internet and through international mail.

Wei said it was “regrettable” that the United States decided to announce the case “unilaterally” because it would affect China’s ongoing investigations.

(Reporting by Philip Wen; Editing by Paul Tait)