Tag Archives: health

Abbott releases new round of cyber updates for St. Jude pacemakers

The ticker and trading information for St. Jude Medical is displayed where the stock is traded on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., April 28, 2016. REUTERS/Brendan McDermid/File Photo

By Michael Erman

NEW YORK (Reuters) – Abbott Laboratories said on Tuesday it would issue updates to reduce the risk of its St. Jude heart implants being hacked and to warn patients that the devices’ batteries may run down earlier than expected.

It was the second round of updates for the heart implants that Abbott has announced since buying medical device maker St. Jude Medical earlier this year.

The U.S. government launched a probe last year of claims the devices were vulnerable to potentially life-threatening hacks that could cause implanted devices to pace at potentially dangerous rates or cause them to fail by draining their batteries.

The company also identified a separate problem with lithium batteries in its heart devices last year. St. Jude recalled some of its 400,000 implanted heart devices last October due to risk of premature battery depletion, which was linked to two deaths in Europe.

The U.S. Food and Drug Administration said then that hospitals should return unused devices and warned patients with an already implanted device to seek immediate medical attention if they get a low-battery alert.

“Abbott is resolving all old St. Jude Medical issues,” Abbott spokeswoman Candace Steele Flippin said.

The new update will provide doctors with an earlier warning when the batteries in Abbott’s implantable cardioverter defibrillators are at risk of early depletion.

Abbott said it would also update the software embedded in pacemakers to reduce the risk of hacking. The company said there have been no reports of unauthorized access to any patient’s implanted device and that compromising the security of the devices would require a complex set of circumstances.

The FDA said it approved the update to ensure that it addresses the cyber security vulnerabilities, and reduces the risk of patient harm.

The FDA and the Department of Homeland Security confirmed in January that St. Jude devices were vulnerable to hacking. But they said they knew of no cyber attacks on patients with the company’s cardiac implants.

The FDA said the benefits of continuing treatment outweighed cyber risks, and DHS said only an attacker “with high skill” could exploit the vulnerability.

They launched the probe in August after short-selling firm Muddy Waters and cyber security firm MedSec Holdings said the devices were riddled with security flaws that made them vulnerable to potentially life-threatening hacks.

When Muddy Waters went public with the claims, it also disclosed it was shorting shares of St. Jude Medical, which was preparing to sell itself to Abbott. The short-selling firm said it believed that disclosure of the vulnerabilities could cause the $25 billion deal to fall apart, but Abbot completed the deal in January.

(Reporting by Michael Erman; Editing by Dan Grebler and Richard Chang)

Mylan, U.S. finalize $465 million EpiPen settlement

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo

By Nate Raymond

BOSTON (Reuters) – Mylan NV <MYL.O> has finalized a $465 million settlement resolving U.S. Justice Department claims it overcharged the government for its EpiPen emergency allergy treatment, which became the center of a firestorm over price increases.

The U.S. Attorney’s Office in Massachusetts on Thursday announced the accord, which was soon after criticized by some congressional members as being too easy on the drugmaker. It came 10 months after Mylan said it had reached a deal.

The settlement resolved claims that Mylan avoided higher rebates to state Medicaid programs by misclassifying EpiPen as a generic product, even though it was marketed and priced as a brand-name product.

“Taxpayers rightly expect companies like Mylan that receive payments from taxpayer-funded programs to scrupulously follow the rules,” Acting U.S. Attorney William Weinreb said in a statement.

Under the deal, Mylan did not admit wrongdoing. It will reclassify EpiPen and pay the rebate applicable to its new classification as of April 1, 2017.

“Bringing closure to this matter is the right course of action for Mylan and our stakeholders to allow us to move forward,” Mylan Chief Executive Heather Bresch said in a statement.

The deal followed a False Claims Act whistleblower lawsuit filed by French rival Sanofi SA <SASY.PA> in 2016, two years after it first raised the matter with authorities, Weinreb’s office said.

Sanofi, which formerly marketed a rival product called Auvi-Q, will receive nearly $38.8 million as a reward from the government.

Sanofi in a statement called pursuing the matter “the right thing to do.” It has a separate antitrust lawsuit pending alleging Mylan engaged in illegal conduct to squelch competition to EpiPen.

Mylan shares rose 2.10 percent to $31.11 on the Nasdaq.

The EpiPen, which Mylan acquired in 2007, is a handheld device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine.

Mylan came under fire last year after raising the price of a pair of EpiPens to $600, from $100 in 2008, enraging consumers and putting it in the center of the ongoing U.S. debate over the high cost of prescription medicines.

Mylan has since offered its own generic version for about $300. The company announced it had reached a Justice Department settlement in October.

Some congressional members previously criticized the $465-million settlement as too small. U.S. Senator Richard Blumenthal, a Democrat from Connecticut, renewed that position on Thursday, calling it “completely insufficient.”

A U.S. Department of Health and Human Services’ Office of Inspector General analysis released in May found the U.S. government may have overpaid for EpiPens by up to $1.27 billion between 2006 and 2016.

“Absolving Mylan from a finding of wrongdoing has cleared the way for the company to pocket the money it embezzled from an American public in desperate need of lifesaving and affordable medications,” Blumenthal said in a statement.

Republican Senator Chuck Grassley of Iowa in a statement called the accord a “disappointment,” saying it “looks like the settlement amount short-changes the taxpayers.”

Mylan shares were up 0.1 at $30.50 in late trading.

 

(Reporting by Nate Raymond in Boston; Editing by Nick Zieminski)

 

Anthem to pare back Obamacare offerings in Nevada and Georgia

FILE PHOTO: The office building of health insurer Anthem is seen in Los Angeles, California February 5, 2015. REUTERS/Gus Ruelas/File Photo

(Reuters) – U.S. health insurer Anthem Inc <ANTM.N> said on Monday it will no longer offer Obamacare plans in Nevada’s state exchange and will stop offering the plans in nearly half of Georgia’s counties next year.

The moves come after Republican senators last month failed to repeal and replace Obamacare, former President Barack Obama’s signature healthcare reform law, creating uncertainty over how the program providing health benefits to 20 million Americans will be funded and managed in 2018.

Hundreds of U.S. counties are at risk of losing access to private health coverage in 2018 as insurers consider pulling out of those markets in the coming months.

Nevada had said in June that residents in 14 counties out of 17 in the state would not have access to qualified health plans on the state exchanges. Anthem’s decision to leave the state entirely does not increase the number of “bare counties” in the state, Nevada Insurance Commissioner Barbara Richardson said in a statement.

The insurer will still offer “catastrophic plans,” which can be purchased outside the state’s exchange and are only available to consumers under 30 years old or with a low income.

Anthem also said it will only offer Obamacare plans in 85 of Georgia’s 159 counties. It said the counties it will continue to offer the plans in are mostly rural counties that would otherwise not have health insurance coverage for their residents.

It said these changes do not impact Anthem’s Medicare Advantage, Medicaid or employer-based plans in either state.

The company said last week that it will pull out of 16 of 19 pricing regions in California in 2018 where it offered Obamacare options this year.

Anthem blamed the moves in part on uncertainty over whether the Trump administration would maintain subsidies that keep costs down.

U.S. President Donald Trump last week threatened to cut off subsidy payments that make the plans affordable for lower-income Americans and help insurers to keep premiums down, after efforts to repeal the law signed by his predecessor, President Barack Obama, failed in Congress.

Trump has repeatedly urged Republican lawmakers to keep working to undo Obama’s Affordable Care Act.

(Reporting by Michael Erman and Bill Berkrot in New York; Editing by Chizu Nomiyama and Lisa Shumaker)

Chicago sugary drink tax to take effect next week after ruling

Soda in Walmart

By Julia Jacobs

CHICAGO (Reuters) – A sweetened beverage tax will take effect in Chicago on Wednesday after an Illinois judge threw out a lawsuit by retailers that argued the measure was vague and unlawful.

Cook County, which includes Chicago and surrounding suburbs, joins a growing number of localities across the United States that have adopted measures to cut consumption of sugary drinks for health reasons, including Seattle and San Francisco.

Cook County Circuit Court Judge Daniel Kubasiak decided in the county’s favor on Friday, about a month after he had halted implementation of the penny-per-ounce tax in response to the lawsuit by the Illinois Retail Merchants Association.

“We believed all along that our ordinance was carefully drafted and met pertinent constitutional tests,” Cook County Board President Toni Preckwinkle said in a statement released after the ruling.

The retailers had argued the tax was unlawful because it exempted custom-made sweetened beverages, such as coffee drinks made in a cafe, and only taxed pre-made beverages, such as sodas, sports drinks and flavored water.

In his order on Friday, Kubasiak agreed with the county that there was a significant distinction between taxing the two types of sugary beverages.

County attorneys had also argued that taxing custom-made beverages would put an excessive administrative burden on the county, and that taxing widely available pre-made beverages would be more effective in improving public health.

Preckwinkle said in the statement that the county, which passed the tax in November, lost at least $17 million in revenue in the weeks in which the measure was delayed.

Kubasiak said in his order that he was aware of the county’s “budgetary turmoil” as a result of the revenue loss but that it did not factor in to his decision making. “The Court is not party to the County’s budget matters and is not moved by its public airing of those matters,” he said.

In response to the plaintiffs’ claims that the technology needed to collect the tax would not be ready for quick implementation, Preckwinkle said the retailers should have been prepared to collect the tax a month ago.

David Ruskin, an attorney for the retailers’ association, said the plaintiffs are considering an appeal.

“We are disappointed with today’s ruling,” Rob Karr, president of IRMA, told reporters. “I can only imagine the outrage felt by consumers.”

(Editing by Patrick Enright and Matthew Lewis)

First editing of human embryos carried out in United States

(Reuters) – Technology that allows alteration of genes in a human embryo has been used for the first time in the United States, according to Oregon Health and Science University (OHSU) in Portland, which carried out the research.

The OHSU research is believed to have broken new ground both in the number of embryos experimented upon and by demonstrating it is possible to safely and efficiently correct defective genes that cause inherited diseases, according to Technology Review, which first reported the news.

None of the embryos were allowed to develop for more than a few days, according to the report.

Some countries have signed a convention prohibiting the practice on concerns it could be used to create so-called designer babies.

Results of the peer-reviewed study are expected to be published soon in a scientific journal, according to OHSU spokesman Eric Robinson.

The research, led by Shoukhrat Mitalipov, head of OHSU’s Center for Embryonic Cell and Gene Therapy, involves a technology known as CRISPR that has opened up new frontiers in genetic medicine because of its ability to modify genes quickly and efficiently.

CRISPR works as a type of molecular scissors that can selectively trim away unwanted parts of the genome, and replace it with new stretches of DNA.

Scientists in China have published similar studies with mixed results.

In December 2015, scientists and ethicists at an international meeting held at the National Academy of Sciences (NAS) in Washington said it would be “irresponsible” to use gene editing technology in human embryos for therapeutic purposes, such as to correct genetic diseases, until safety and efficacy issues are resolved.

But earlier this year, NAS and the National Academy of Medicine said scientific advances make gene editing in human reproductive cells “a realistic possibility that deserves serious consideration.”

(Reporting By Deena Beasley; Editing by Michael Perry)

Signs of brain disease in 99 percent of former NFL players: study

FILE PHOTO - New England Patriots linebacker Junior Seau celebrates sacking San Diego Chargers quarterback Philip Rivers in first quarter of the NFL's AFC championship football game in Foxborough, Massachusetts, U.S. on January 20, 2008. REUTERS/Brian Snyder/File Photo

By Scott Malone

BOSTON (Reuters) – The brains of 99 percent of former National Football League players showed signs of a disease linked to repeated hits to the head that can lead to aggression and dementia, according to research published in a leading medical journal on Tuesday.

The findings were based on the broadest review yet of the brains of former football players for signs of chronic traumatic encephalopathy. The condition, also known as CTE, is linked to the sort of head-to-head hits that were long a part of the sport, though the NFL and school leagues have been tweaking the game in recent years to limit blows to the head.

“The data suggest that there is very likely a relationship between exposure to football and risk of developing the disease,” said Jesse Mez, a Boston University School of Medicine assistant professor of neurology, who was lead author of the study published in the Journal of the American Medical Association.

The researchers studied the brains of 202 former athletes who had played football in the NFL, the Canadian Football League or at the college or high school level and found signs of CTE in the brains of 110 of the former 111 NFL players.

The condition, which currently can be diagnosed only by taking brain tissue from a dead subject, has been diagnosed in former players including Hall of Fame linebacker Junior Seau and Pro Bowl safety Dave Duerson, who both committed suicide.

The researchers noted that the study had limitations including that the subjects’ brains were donated by their families, and that families are more likely to opt into the study if the players had showed symptoms of CTE.

“We do not know what proportion of football players, or any group, for that matter, develop CTE,” said Dr. Munro Cullum, a neuropsychologist with the O’Donnell Brain Institute at the University of Texas Southwestern Medical Center in Dallas.

The NFL, which last year pledged $100 million for neuromedical research, said the study would help the league and players to understand the condition.

“The NFL is committed to supporting scientific research into CTE and advancing progress in the prevention and treatment of head injuries,” said NFL spokesman Brian McCarthy, in an e-mail.

The study found signs of CTE in the brains of 91 percent of the 53 former college players whose brains were studied and 21 percent of the former high school players.

(Reporting by Scott Malone, additional reporting by Lisa Rapaport in New York; Editing by Andrew Hay)

Dengue outbreak kills 300 in Sri Lanka, hospitals at limit

A mosquito landing on a person. Courtesy of Pixabay

COLOMBO (Reuters) – An outbreak of dengue virus has killed around 300 people so far this year in Sri Lanka and hospitals are stretched to capacity, health officials said on Monday.

They blamed recent monsoon rains and floods that have left pools of stagnant water and rotting rain-soaked trash — ideal breeding sites for mosquitoes that carry the virus.

The International Federation of Red Cross and Red Crescent Societies is scaling up emergency assistance to Sri Lanka with the Sri Lanka Red Cross to help contain the outbreak.

“Dengue patients are streaming into overcrowded hospitals that are stretched beyond capacity and struggling to cope, particularly in the country’s hardest hit western province,” Red Cross/Red Crescent said in a statement.

According to the World Health Organization, dengue is one of the world’s fastest growing diseases, endemic in 100 countries, with as many as 390 million infections annually. Early detection and treatment save lives when infections are severe, particularly for young children.

The Sri Lankan government is struggling to control the virus, which causes flu-like symptoms and can develop into the deadly hemorrhagic dengue fever.

The ministry of health said the number of dengue infections has climbed above 100,000 since the start of 2017, with 296 deaths.

“Ongoing downpours and worsening sanitation conditions raise concerns the disease will continue to spread,” Red Cross/Red Crescent said.

Its assistance comes a week after Australia announced programs to help control dengue fever in Sri Lanka.

“Dengue is endemic here, but one reason for the dramatic rise in cases is that the virus currently spreading has evolved and people lack the immunity to fight off the new strain,” Novil Wijesekara, head of health at the Sri Lanka Red Cross said in a statement.

(Reporting by Ranga Sirilal and Shihar Aneez Editing by Jeremy Gaunt.)

Senator McCain diagnosed with aggressive brain cancer

FILE PHOTO: U.S. Senator John McCain attends a news conference at the Benjamin Franklin Library in Mexico City, Mexico December 20, 2016. REUTERS/Henry Romero/File Photo

By Patricia Zengerle

WASHINGTON (Reuters) – U.S. Senator John McCain, the 2008 Republican presidential nominee known for political independence during more than three decades in the Senate, has been diagnosed with an aggressive form of brain cancer, his office said on Wednesday.

The 80-year-old lawmaker and former Navy pilot, who was re-elected to a sixth Senate term in November, has been recovering at home in Arizona since undergoing surgery at the Mayo Clinic in Phoenix last Friday to remove a blood clot from above his left eye.

Tissue analysis since that procedure revealed that a brain tumor known as a glioblastoma was associated with the clot, his office said.

McCain’s doctors said he was recovering from surgery “amazingly well” and that his underlying health was excellent. Treatment options include a combination of chemotherapy and radiation.

However, glioblastoma is considered a grade IV tumor, the most malignant of gliomas. Medical experts said it can be very aggressive and spread into other parts of the brain quickly.

“It takes people’s lives almost uniformly … The tumor cells are very resistant to conventional therapy, such as radiation and chemotherapy. It’s a poor prognosis,” said Dr. Richard Ellenbogen, who chairs the Department of Neurological Surgery at the University of Washington.

McCain’s daughter, Meghan McCain, said the family was shocked by the diagnosis but that her father was the “most confident and calm” of them all as he prepared for a new battle against cancer.

McCain has had non-invasive melanomas removed at least three times. He also overcame injuries suffered as a prisoner of war in Vietnam, where he endured beatings and torture by his North Vietnamese captors.

Questions about McCain’s health arose during a recent Senate hearing when the lawmaker, normally a keen interrogator of witnesses, rambled during questioning of former FBI Director James Comey. His doctors told CNN on Wednesday, however, that he had no sign of neurological impairment before or during his surgery.

His fellow members of Congress rushed to offer tributes to McCain and wishes for his quick recovery. Known for an independent political streak, ready wit and strong opinions, McCain is one of the best-known and most popular U.S. lawmakers among his peers and the media.

Senator Lindsey Graham, a long-time friend, said McCain was “resolved and determined” when they spoke by telephone. “This disease has never had a more worthy opponent.”

While known as a fierce advocate for strong U.S. military action overseas, McCain also has a reputation for working with Democrats on issues from clamping down on campaign finance abuses to immigration reform. This week, McCain called for a bipartisan approach to overhauling the U.S. healthcare system.

‘GIVE IT HELL, JOHN’

“Senator John McCain has always been a fighter,” said President Donald Trump. “Get well soon.”

Former Democratic President Barack Obama, who defeated McCain for the White House in 2008, called McCain “an American hero and one of the bravest fighters I’ve ever known. Cancer doesn’t know what it’s up against. Give it hell, John.”

McCain was one of Congress’ most vocal critics of Obama’s foreign policy, but he has also raised questions about Trump, a fellow Republican.

McCain found himself to be a brief side issue in the race for the 2016 Republican presidential nomination when he criticized Trump, who responded by saying McCain was not a war hero because he had been captured by the Vietnamese.

Senate Majority Leader Mitch McConnell called McCain, the chairman of the Armed Services Committee, a hero and said he looked forward to having him back in Washington.

McCain, the son and grandson of admirals, was a U.S. Navy pilot. His plane was shot down over Vietnam in 1967 and he spent 5-1/2 years as a prisoner of war.

One of McCain’s proudest moments as a U.S. senator was working to pass legislation banning torture in 2015.

When he was offered release because of his father’s rank, McCain refused to be freed before those who had been held captive longer. He finally returned to the United States in 1973, with other prisoners of war.

McCain’s absence this week has complicated efforts by Trump and his fellow Republicans to repeal Obama’s Affordable Care Act, popularly known as Obamacare. McCain’s absence from Washington makes it difficult for McConnell to gather the 50 votes he needs in a chamber where the party holds only a 52-48-seat margin.

His absence could also complicate progress toward passing the annual National Defense Authorization Act, a $700 billion piece of legislation setting policy for the Department of Defense that must pass every year.

(Reporting by Patricia Zengerle; Additional reporting by Steve Holland, Richard Cowan and Yasmeen Abutaleb in Washington, Eric M. Johnson in Seattle and Dan Whitcomb in Los Angeles; Editing by Kieran Murray and Peter Cooney)

Chipotle to reopen Virginia restaurant after norovirus reports

FILE PHOTO - A Chipotle Mexican Grill is seen in Los Angeles, California, U.S. on April 25, 2016. REUTERS/Lucy Nicholson/File Photo

BOSTON (Reuters) – Chipotle Mexican Grill Inc said it will reopen a Virginia restaurant on Wednesday, two days after it was closed due to reports that several customers had fallen ill with suspected norovirus.

Shares of the restaurant chain tumbled more than 4 percent on Tuesday after Chipotle reported the closure. The former high-flying chain is still fighting to repair its reputation and resuscitate its sales after a string of high-profile food safety lapses in late 2015.

Chipotle voluntarily closed the restaurant in Sterling, Virginia, on Monday, according to a health official for the Loudoun County Public Health Department, which has jurisdiction over the restaurant, about 30 miles (48 km) northwest of Washington.

About 13 people became sick last week, according to a website that follows incidents of foodborne illness. Test results are still pending.

Chipotle stock, which traded well above $700 prior to 2015 reports linking the chain to outbreaks of E. coli, salmonella and norovirus, was off 1.4 percent at $369.56 on Wednesday.

“It is unfortunate that anyone became ill after visiting our restaurant, and when we learned of this issue, we took aggressive action to correct the problem and protect our customers,” Chipotle Chief Executive Officer Steve Ells said in a statement.

“While the restaurant was closed, multiple teams performed complete sanitization of all surfaces,” Ells said.

Norovirus, is the leading cause of illness and outbreaks from contaminated food in the United States, according to the Centers for Disease Control and Prevention.

It can spread from person to person, as well as through food prepared by an infected person. It often hits closed environments such as daycare centers, schools and cruise ships. Most outbreaks happen from November to April in the United States.

(Reporting by Lisa Baertlein in Boston; Editing by Jeffrey Benkoe)

U.S. Senate Republicans set repeal vote as healthcare overhaul sinks

FILE PHOTO - U.S. Senate Majority Leader Mitch McConnell speaks to the media about plans to repeal and replace Obamacare on Capitol Hill in Washington, DC, U.S. on June 27, 2017. REUTERS/Aaron P. Bernstein/File Photo

By Susan Cornwell

WASHINGTON (Reuters) – U.S. Senate Republican leader Mitch McConnell set a vote on a straight repeal of Obamacare after efforts to overhaul the healthcare law collapsed, but the new approach unraveled within hours on Tuesday in a sharp setback for President Donald Trump and his Republican Party.

The disarray in the Republican-controlled Senate rattled financial markets and cast doubt on the chances for getting Trump’s other domestic policy priorities, such as tax reform, through a divided Congress.

Repealing and replacing Obamacare has been a top Republican goal for seven years, and Trump made the promise a centerpiece of his White House campaign. The overhaul’s failure calls into question not only his ability to get his agenda through Congress but that of the Republican Party to govern effectively.

Saying he was disappointed, Trump told reporters at the White House that “we’re probably in that position where we’ll just let Obamacare fail.”

“We’re not going to own it, I’m not going to own it. … Republicans are not going to own it. We will let Obamacare fail, and then the Democrats are going to come to us,” he said.

McConnell gave up on efforts to overhaul the 2010 Affordable Care Act late on Monday after it became clear he did not have the votes. Instead, he announced plans to vote in coming days on a two-year transition to simply repeal the healthcare law with no replacement.

“We will now try a different way to bring the American people relief from Obamacare,” McConnell said on Tuesday as he opened the Senate, where the Republicans hold a razor-thin 52-48 majority. “I think we owe them at least that much.”

But Republican Senators Shelley Moore Capito of West Virginia, Susan Collins of Maine and Lisa Murkowski of Alaska quickly announced they would not back repeal, dooming the fledgling effort. With Democrats united in opposition, Republicans can only afford to lose two votes to pass the measure in the Senate.

(Writing by John Whitesides; Additional reporting by Caroline Humer in New York and Ginger Gibson, Richard Cowan in Washington; Editing by Tom Brown, Nick Zieminski and Jonathan Oatis)