St. Jude warns of heart device battery issue linked to two deaths

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

By Jim Finkle

(Reuters) – St. Jude Medical Inc warned on Tuesday that some of its implanted heart devices were at risk of premature battery depletion, a condition it said had been linked to two deaths.

News of the issue surfaced late on Monday when short-selling firm Muddy Waters tweeted a copy of a physician advisory on the matter from St. Jude, which agreed in April to sell itself for $25 billion to Abbott Laboratories.

The letter said problems with the lithium batteries that power the devices were rare and could be identified by patients using tools for monitoring battery levels at home.

Patients should seek immediate medical attention as soon as they get a low-battery alert from the monitoring devices, the U.S. Food and Drug Administration said, adding that St. Jude Medical had initiated a recall of the defibrillators.

St. Jude’s shares were down 2.4 percent at $79.35 in premarket trading on Tuesday, while Abbott’s were down 1.7 percent at $42.75. A spokesman for the drugmaker said it still expected to close the St. Jude deal by the end of the year.

The advisory comes as St. Jude is defending itself against unrelated allegations that its heart devices are riddled with defects that make them vulnerable to fatal cyber hacks.

Those claims were made by Muddy Waters and research firm MedSec Holdings. St. Jude has denied the allegations and sued both firms.

The FDA said on Tuesday its investigation into the cyber security vulnerabilities of the devices, including the Merlin@Home monitoring system, was continuing.

“Despite the allegations, at this time, the FDA strongly recommends that the Merlin@Home device be used to monitor the battery for these affected devices because the benefits of continued patient monitoring and the life-saving therapy these devices provide greatly outweighs any potential cybersecurity vulnerabilities,” the FDA said in a statement.

SMALL RISK

St. Jude said that out of nearly 400,000 devices manufactured through May last year, it had identified 841 failed implanted cardioverter defibrillators with lithium clusters, which can form after a device delivers electricity to the heart.

Lithium clusters sometimes cause battery power to deplete quickly, rendering devices unable to deliver doses of electricity when needed, St. Jude’s vice president of quality control, Jeff Fecho, said in a physician advisory.

“There have been two deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion,” Fecho wrote in the letter.

Cowen & Co analysts said in a note that while such letters were never a positive, they were common in the industry and there was little risk to St. Jude’s business.

St. Jude advised physicians to replace devices with damaged batteries immediately, but cautioned against swapping out devices that were operating normally because of the potential for complications.

“While this risk is very small, we have provided doctors with information so that they can discuss the most appropriate course of action for each individual patient,” St. Jude’s chief medical officer, Mark Carlson, said in a statement.

St. Jude advised patients to check its website for details on which devices were affected. (http://www.sjm.com/batteryadvisory).

The site tells patients how they can monitor battery activity, look for vibrating alerts when batteries are low and connect to the Merlin.net remote monitoring service.

Battery-depletion advisories have issued in the past by Boston Scientific Corp and Medtronic Plc .

(Reporting by Jim Finkle in Boston and Ankur Banerjee and Natalie Grover in Bengaluru; Editing by Paul Tait and Ted Kerr)

Briefly standing, or being active, reduces blood sugar across the day

People walk and exercise by a lake in Yangon at sunrise

By Kathryn Doyle

(Reuters Health) – For obese people who sit for most of the day, replacing some sitting time with standing, slow walking or slow cycling reduces average blood sugar across the day and into the night, a small study finds.

“Anything you can do to bring down glucose readings throughout the day is a good thing,” said senior author Glenn Gaesser of the School of Nutrition and Health Promotion at Arizona State University in Phoenix

“We chose a typical workday because a large number of Americans spend a lot of time sitting at an office desk, and a number of (studies) indicate sitting is a health hazard, so we reckoned that trying to alleviate that by either standing or walking or cycling would help,” Gaesser told Reuters Health.

The researchers studied nine overweight or obese adults who wore continuous blood sugar monitors and blood pressure monitors during their regular, mostly-sitting eight-hour workday. One week later, participants gradually replaced some of that sitting time with standing, in intervals of 10 to 30 minutes for a total of two and half hours per day.

The following week, the same amount of sitting time was replaced with walking at a treadmill desk at a pace of one mile per hour. In the fourth week, the intervals were spent cycling on a stationary bike retrofitted to a workstation, also at an extremely slow pace with low energy expenditure.

Average 24-hour glucose was lower for standing and walking than for sitting, and was lowest on the cycling days, the researchers report in Medicine and Science in Sports and Exercise.

There was a similar pattern during the hours right after eating and even during overnight hours, with people having sustained lower blood sugar overnight after days they had cycled.

This is “not wholly surprising,” because other research in the last few years has shown that breaking up prolonged sitting has benefits on glucose over the course of a day, said Dr. Daniel Bailey of the University of Bedforshire in the U.K., who was not part of the study.

It’s uncertain if the difference in blood sugar would have clinical significance or reduce metabolic risk, but that would be more likely for walking and cycling than for standing, which only resulted in a small reduction, Bailey told Reuters Health by email.

“Studies with larger groups would be needed before we could say these findings would apply to overweight people in general,” he said. But it’s likely that overweight or prediabetic people may benefit more from breaking up periods of sitting than healthy-weight people, he said.

“We found that the overall reduction in blood sugar throughout the 24-hour day was typically 5 percent to 12 percent, with the greatest effect being in cycling,” Gaesser said.

After a meal of carbohydrates, most blood sugar is disposed of in skeletal muscle, and muscle contractions increase insulin activity and glucose uptake, which helps to lower blood sugar, he said.

“For low-level activity throughout the workday, the effect lasts well after the last exercise bout at 4:30 or 5:00 in the afternoon,” continuing into sleep, he said.

Breaks in sedentary time are good, even if you don’t have access to a walking or cycling workstation, Gaesser said.

SOURCE: http://bit.ly/2aORinW Medicine and Science in Sports and Exercise, online July 27, 2016.

U.S. government shifts $81 million to Zika vaccine research

Zika prevention kit for pregnant women

By Julie Steenhuysen and Toni Clarke

CHICAGO/WASHINGTON (Reuters) – The U.S. Department of Health and Human Services has shifted $81 million in funds from other projects to continue work on developing vaccines to fight Zika in the absence of any funding from U.S. lawmakers.

In a letter addressed to Nancy Pelosi, a Democrat and minority leader of the U.S. House of Representatives, HHS Secretary Sylvia Burwell said she was allocating $34 million in funding to the National Institutes of Health and $47 million to the Biomedical Advanced Research and Development Authority (BARDA) to work on Zika vaccines.

Burwell said the funding was intended to keep Zika vaccine research going despite the lack of funding from U.S. lawmakers, who left for summer recess before allocating any funding to Zika research and preparedness.

The mosquito-borne Zika virus has spread to more than 50 countries and territories since the outbreak began last year in Brazil. On Thursday, Governor Rick Scott said state health officials have identified three additional people in the affected area with locally transmitted Zika, bringing the total to 25.

The Obama administration in February requested $1.9 billion to fight Zika, but congressional lawmakers have been considering a much smaller sum. A bill providing $1.1 billion was blocked by Democrats after Republicans attached language to stop abortion-provider Planned Parenthood from using that government funding for healthcare services, mainly in U.S. territories like Puerto Rico.

The Republican legislation also would siphon off unused money under President Barack Obama’s signature 2010 healthcare law to combat Zika. In addition, Democrats balked at a Republican provision that they said would gut clean water protections.

The new bolus of funds from HHS comes on top of the $589 million in repurposed funds previously allocated for Ebola efforts. HHS has said these funds will run out at the end of August.

At a press briefing in Washington, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he needs $33 million to prepare to move the first potential Zika vaccine to the second phase of human clinical trials. The first phase of that testing is expected to end in late November or December.

Fauci said the health secretary has the authority to transfer 1 percent of NIH’s $33 billion budget per year from one Institute to the other. He said the director of the NIH, Dr. Francis Collins, will decide which existing programs the funds will be drawn from.

“He will probably do it on a prorated basis across the Institutes,” he said.

Fauci said the budget transfer will not fill the longer-term NIH funding needs to fight the virus and to develop a second or third potential vaccine candidate. Drugs frequently fail to realize the promise they show in early trials.

“We still need about $196 million more,” he said.

Fauci said the health secretary’s action was essentially one of desperation given the failure of Congress to authorize additional funding.

Taking money from other research programs “is extremely damaging to the biomedical research enterprise,” he said. “We’re taking money away from cancer, diabetes, all those things.”

Dr. LaMar Hasbrouck, executive director of the National Association of County and City Health Officials, said at the briefing that local health authorities are similarly siphoning off money from other programs.

“We’re robbing Peter to pay Paul,” he said.

In her letter, Burwell said the $47 million in funding for BARDA will allow the agency to enter into contracts with key partners to develop vaccines. But, she said BARDA will need an estimated $342 million in additional funding to continue its work with outside partners in the development of vaccines, diagnostics and pathogen inactivation technology used to protect the U.S. blood supply.

(Reporting by Julie Steenhuysen in Chicago and Toni Clarke in Washington; editing by Grant McCool and Bernard Orr)

Parents who insist vegan diet for children may risk jail in Italy

Italy's member of parliament and PDL party Savino and Prime Minister Berlusconi attend debate in the upper house of Parliament in Rome

By Philip Pullella

ROME (Reuters) – If parliamentarian Elvira Savino has her way, Italian parents who insist on a vegan diet for their children will risk up to four years in jail.

Savino, from the conservative Forza Italia party, has put forward a law that would hold parents legally responsible for feeding their children on “a diet devoid of elements essential for healthy and balanced growth”, according to its text.

“I have nothing against vegans or veganism as long as it is a free choice by adults,” she told Reuters in a telephone interview on Wednesday, days after she presented the proposed law in the lower house Chamber of Deputies.

“I just find it absurd that some parents are allowed to impose their will on children in an almost fanatical, religious way, often without proper scientific knowledge or medical consultation,” she said.

“Do-it-yourself on these matters terrorizes me.”

Some pediatricians advise against feeding children on a vegan diet, which they say can lack sufficient nutrition.

Vegetarians do not eat meat, fish, or poultry and vegans also do not eat animal products such as eggs and dairy foods.

The law proposes jail sentences of a year for raising a child on a vegan diet, up to four years if the child develops a permanent health problem and up to seven years if the child dies as a result.

It would apply to children under 16 and penalties would increase by a year if the child is under three.

Savino, 39, who has a seven-year-old son and who eats meat “but not too much”, said she proposed the law after being shocked by several recent incidents in Italy.

Last month in the northern city of Milan, doctors determined that a one-year-old boy who was taken to a hospital had the weight of a three-month-old because of a vegan diet.

In 2015, an Italian court ordered a divorced mother to stop raising her 12-year-old son on a vegan diet after the boy’s father filed a complaint that it was stunting his growth.

“If even only one child ends up in a hospital because of this behavior, I feel we have to protect them all,” said Savino, noting that she believes pediatricians should be obliged to report vegan parents to authorities just as they would if they noticed signs of physical abuse on a child.

The draft will be discussed by parliamentary committees before it goes to the floor for debate. That is expected this year.

(Editing by Louise Ireland)

Future of health, drug pricing: paying for benefits not per pill

A customer waits at the counter of a CVS Pharmacy store in Pasadena, U.S

By Ben Hirschler

LONDON (Reuters) – Global pressure on health spending is forcing the $1 trillion-a-year pharmaceutical industry to look for new ways to price its products: charging based on how much they improve patients’ health, rather than how many pills or vials are sold.

In the United States, both parties are promising fresh action on drug prices whoever wins the White House. In Europe, economies are stalled, squeezing state health budgets. And in China and other Asian markets, governments are getting tougher with suppliers.

Pricing drugs based on clinical outcomes is one way to ensure that limited funds bring the most benefits to patients now and pay for the most promising medical advances in future. Some experiments in pricing have already been made.

But shifting the overall industry to a new model requires improvements in data collection and a change in thinking, say drug pricing experts.

“Eventually, we are going to get there,” said Kurt Kessler, managing principal at ZS Associates in Zurich, which advises companies on sales and marketing strategies. “But it is a long, tough slog because it’s difficult to get the right data and agree on what the right outcomes are to measure.”

In the past, governments and insurers made room in their budgets for new drugs by switching to cheap generics as patents expired on older drugs. But today generics already account for nearly nine out of every 10 prescriptions in key markets like the United States, and fewer big drugs are going off patent.

That leaves little headroom for pricey new medicines for cancer and other hard-to-treat diseases, even as they come to market in growing numbers. The U.S. Food and Drug Administration has already approved 16 new drugs this year.

Investors got a wake-up call on the issue last Friday when $10 billion was lopped off the market value of Novo Nordisk <NOVOb.CO> as the world’s biggest diabetes firm warned of falling U.S. prices.

Pharmacy benefit managers administering U.S. health plans are pushing back hard by excluding some drugs deemed too expensive – including Novo’s – leading to a crunch in areas like diabetes, a disease that now accounts for 12 percent of global healthcare spending.

The Danish group has an unusually high exposure to the U.S. market, but it is not alone in signaling tough times ahead.

The chief executives of Novartis, Eli Lilly and GlaxoSmithKline have all warned recently that pricing will become increasingly challenging across the board.

Accounting for 40 percent of global drug sales, the fate of the U.S. market is front and center in the minds of drug company executives, some of whom privately admit to preparing for a “confrontational” period in relations with politicians.

Both Hillary Clinton and Donald Trump have suggested new measures to curb prices, including allowing imports from lower-cost countries, while individual U.S. states, starting with Vermont, are working on transparency legislation that would require firms to disclose costs to justify drug prices.

Novartis CEO Joe Jimenez believes drugmakers must develop value-for-money pricing models, like the performance-based deal the Swiss drugmaker recently struck with two U.S. insurers for its new heart failure drug.

Under that deal, payments for Novartis’ Entresto pill are to be calculated in future based on the proven reduction in the proportion of the insurers’ patients admitted to hospital for heart failure, not on the number of pills they consume.

The aim is a flexible pricing system that rebates healthcare providers when a drug doesn’t work as planned and charges more when it works well.

EUROPE IN VANGUARD

Europe is in the vanguard of such moves. Britain agreed an early performance-based deal for a Johnson & Johnson blood cancer drug back in 2007 and Italy also uses patient data to pay for cancer drugs based on actual patient responses.

GSK CEO Andrew Witty sees this outcomes-based approach slowly becoming the norm in more disease areas and geographies.

“Whoever wins the election in the U.S., and also in Europe, we will see those conversations play out over the next few years,” he told Reuters. “I am not particularly expecting anything dramatic in 2017. I would say it is worth keeping an eye open for evolution of change, probably in ’18 and ’19.”

The pharmaceutical industry’s European trade association is already discussing ways to shift to outcomes pricing, following price curbs in Germany that have caused some companies to pull products off the market, and effective rationing in Britain, where strict cost-effectiveness rules apply.

Authorities in Asia’s two biggest markets, China and Japan, are also intervening in new ways to cap runaway costs.

Dani Saurymper, manager of the AXA Framlington Health fund, believes the issue is going to move up the agenda for investors, not least with the arrival of gene and cell therapies. These could cure diseases like haemophilia and certain cancers, but at a cost of hundreds of thousands or even $1 million a patient.

“Pay for performance is going to become much more relevant,” he said.

Still, the obstacles are formidable. Drug companies and healthcare providers will need to work together to develop systems that capture and prove a medicine’s clinical value, ideally using computerized systems that are only just emerging.

There are also potential legal pitfalls, given the need to establish clear-cut clinical outcomes for patients and determine how much of an effect should be attributed to the medicine or other healthcare inputs.

“Overall, it is the right direction but there are many practical difficulties,” said Helen Roberts, a specialist in healthcare at law firm BonelliErede. “There may well be legal challenges if there is disagreement as to whether an outcome has actually been achieved.”

(Additional reporting by Simon Jessop)

China’s ‘mosquito factory’ aims to wipe out Zika, other diseases

mosquitoes being released

GUANGZHOU, China (Reuters) – Every week, scientists in southern China release 3 million bacteria-infected mosquitoes on a 3 km (two-mile) long island in a bid to wipe out diseases such as dengue, yellow fever and Zika.

The scientists inject mosquito eggs with wolbachia bacteria in a laboratory, then release infected male mosquitoes on the island on the outskirts of the city of Guangzhou.

The bacteria, which occurs naturally in about 28 percent of wild mosquitoes, causes infected males to sterilize the females they mate with.

“The aim is trying to suppress the mosquito density below the threshold which can cause disease transmission,” said Zhiyong Xi, who is director of the Sun Yat-sen University Centre of Vector Control for Tropical Diseases and pioneered the idea.

“There are hot spots,” Xi said. “This technology can be used at the beginning to target the hot spots … it will dramatically reduce disease transmission.”

Mosquito-borne diseases are responsible for more than one million deaths worldwide every year and Zika has become a concern for athletes at this year’s Olympic Games, which open in Rio de Janeiro on Friday.

Some athletes, including the top four ranked male golfers, have declined to take part.

An outbreak of the Zika virus in Brazil last year has spread through the Americas and beyond, with China confirming its first case in February.

U.S. health officials have concluded that Zika infections in pregnant women can cause microcephaly, a birth defect marked by small head size that can lead to severe developmental problems in babies.

The World Health Organization has said there is strong scientific consensus that Zika can also cause Guillain-Barre, a rare neurological syndrome that causes temporary paralysis in adults.

Sun Yat-sen’s Xi said that several countries had expressed interest in his experiments, especially Brazil and Mexico.

In the laboratory, mosquito eggs are collected from breeding cages containing 5,000 females and 1,600 males and injected with the wolbachia bacteria. Xi’s facility has the capacity to breed up to five million mosquitoes a week.

While a female mosquito that acquires wolbachia by mating is sterile, one that is infected by injection will produce wolbachia-infected offspring. Dengue, yellow fever and Zika are also suppressed in wolbachia-injected females, making it harder for the diseases to be transmitted to humans.

Xi set up his 3,500 square meter (38,000 sq ft) “mosquito factory” in 2012 and releases the males into two residential areas on the outskirts of Guangzhou.

Xi said the mosquito population on the island has been reduced by more than 90 percent.

One villager on the island, 66 year-old Liang Jintian, who has lived there for six decades, said the study was so effective he didn’t have to sleep with a mosquito net any longer.

“We used to have a lot of mosquitoes in the past. Back then some people were worried that if mosquitoes were released here, we would get even more mosquitoes,” he said. “We have a lot less mosquitoes now compared to the past.”

(Reporting by Reuters TV; Writing by Clare Baldwin; Editing by Robert Birsel)

Study finds cosmic rays increased heart risks among astronauts

Astronaut Edwin E. Aldrin Jr., lunar module pilot, walks on the surface of the moon near the leg of the Lunar Module (LM) "Eagle" during the Apollo 11 extravehicular activity (EVA in this NASA handout photo

By Irene Klotz

CAPE CANAVERAL, Fla. (Reuters) – Apollo astronauts who ventured to the moon are at five times greater risk of dying from heart disease than shuttle astronauts, U.S. researchers said on Thursday, citing the dangers of cosmic radiation beyond the Earth’s magnetic field.

The study by researchers at Florida State University and NASA found that three Apollo astronauts, including Neil Armstrong, the first person to walk on the moon, or 43 percent of those studied, died from cardiovascular disease, a finding with implications for future human travel beyond Earth.

The research, published in the journal Scientific Reports, was the first to look at the mortality of Apollo astronauts, the only people so far to travel beyond a few hundred miles (km) of Earth.

It found that the chief health threat to the Apollo astronauts came from cosmic rays, which are more prevalent and powerful beyond the magnetic bubble that surrounds Earth.

NASA disputed the findings, saying it was too early to draw conclusions about the effect of cosmic rays on Apollo astronauts because the current data is limited.

The results of the study have implications for the United States and other countries, as well as private companies, such as Elon Musk’s SpaceX, which are planning missions to Mars and other destinations beyond Earth.

For the study, the researchers examined the death records of 42 astronauts who flew in space, including seven Apollo veterans, and 35 astronauts who died without ever going into space.

They found the Apollo astronauts’ mortality rate from cardiovascular disease was as much as five times higher than for astronauts who never flew, or for those who flew low-altitude missions aboard the space shuttle that orbited a few hundred miles above Earth.

A companion study simulated weightlessness and radiation exposure in mice and showed that radiation exposure was far more threatening to the cardiovascular system than other factors, lead scientist Michael Delp said in an interview.

“What the mouse data show is that deep space radiation is harmful to vascular health,” he said.

So far, only 24 astronauts have flown beyond Earth’s protective magnetic shield, in missions spanning a four-year period from December 1968 to December 1972.

Of those, eight have died, seven of whom were included in the study. The cause of death of the eighth astronaut, Apollo 14’s Edgar Mitchell, who died in February 2016, has not been released, so he was excluded from the study, Delp said. Mitchell was the sixth person to walk on the moon.

Delp and colleagues are working on a follow-up study that includes more detail on family medical histories, smoking and other factors.

(Reporting by Irene Klotz; Editing by Julie Steenhuysen and Peter Cooney)

Doctors devise care plan for babies as Zika threat looms in U.S.

mosquito under microscope

By Julie Steenhuysen

CHICAGO (Reuters) – As U.S. public health officials try to determine whether Zika has arrived in the country, doctors are establishing guidelines on how to care for the rising number of babies whose mothers were infected with the virus during pregnancy.

Florida said it is investigating two possible cases of Zika not related to travel to an area where Zika is active, raising the possibility of the first incidence of local transmission of the mosquito-borne virus.

On Thursday, the Florida Department of Health said it was investigating a non travel-related case of Zika in Broward County, marking the second such case. Florida has asked the U.S. Centers for Disease Control and Prevention to assist in its investigation that must also rule out sexual transmission.

So far, 400 pregnant women in the continental United States have evidence of Zika infection, up from 346 from a week ago, the CDC reported on Thursday. All of those were related to travel or sex with an infected person who had traveled.

Three more babies have been born in the United States with birth defects linked to Zika infections in their mothers, bringing the total to 12, CDC said.

Zika has been proven to cause microcephaly, a severe birth defect marked by small head size and undersized brains that requires a complex network of care providers and social workers to treat and provide support to parents.

But microcephaly is just the tip of the iceberg, according to experts speaking at a CDC-sponsored workshop on Thursday. They said many babies exposed in utero who appear normal at birth may have developmental problems down the road, including hearing and vision problems.

For example, babies born without a functional sucking reflex may never develop the ability to swallow and will need to be fed through a feeding tube. These infants will have a higher risk of pneumonia, said Dr. Edwin Trevathan, a pediatrician and child neurologist at Vanderbilt University Medical Center.

Less obvious damage to structures on only one side of the brain may cause seizure disorders that do not appear until adolescence, Trevathan said.

Pediatric experts at the workshop are reviewing the potential consequences of Zika infection and plan to make recommendations on ways to treat Zika-exposed infants.

The connection between Zika and microcephaly first came to light last fall in Brazil, which has now confirmed more than 1,600 cases of microcephaly that it considers related to Zika infections in the mothers.

FLORIDA PROBE

The recommendations come as Florida officials investigate what may be the first cases of Zika in the continental United States caused by the bite of a local mosquito.

Florida officials will not elaborate on how a resident of Miami was infected and whether the first case under investigation was related to mosquitoes.

“We continue to investigate and have not ruled out travel or sexual transmission at this time,” Florida spokeswoman Mara Gambineri said in an email on Thursday. However, she said the state still suspects the case is not related to travel to a Zika-infected area.

The White House on Wednesday released a statement saying President Barack Obama had spoken to Florida Governor Rick Scott regarding a suspected case of mosquito transmission of Zika and promised more money to fight the virus.

At the Zika workshop, Dr. Marc Fischer, chief of surveillance and epidemiology activity at the arboviral diseases branch of the CDC, said the agency has worked with state health departments to establish strategies to identify possible local transmission in the United States.

“When and if there is a case of local transmission, we work with local health departments to identify additional cases to define the geographic scope of the outbreak,” he said.

That includes surveying households and neighbors within a 150-yard radius around the residence of the person who has Zika.

“That’s basically the flying radius of the vector mosquitoes,” he said.

According to the U.S. Zika response plan, Zika local transmission is defined as two or more cases not due to travel or sex with an infected person that occur in a one-mile diameter over the course of a month.

CDC has given Florida $2 million for Zika preparedness, and on Thursday awarded another $5.6 million to assist the state with Zika as part of an additional $60 million in Zika funds to states announced on Thursday. U.S. lawmakers so far have not approved any of the White House’s $1.9 billion request for Zika.

CDC plans to award another $10 million to states and territories on Aug. 1 to speed identification of microcephaly and other birth defects linked to Zika.

(Additional reporting by Bill Berkrot in New York; Editing by Bernard Orr)

Florida health department investigates possible local Zika transmission

Mosquito being studied for Zika

(Reuters) – Florida health officials said on Tuesday they are investigating a case of Zika virus infection that does not appear to have stemmed from travel to another region with an outbreak.

The statement from the Florida Department of Health did not specify whether the Zika case was believed to have been transmitted via mosquito bite, sexual contact or other means.

The department said the case was reported in Miami-Dade County and that it is working with the U.S. Centers for Disease Control and Prevention on an epidemiological study.

The department also reiterated guidance to Florida residents on protecting themselves from mosquitoes that may carry the virus.

“Zika prevention kits and repellant will be available for pickup … and distributed in the area under investigation,” the health department said in a statement. “Mosquito control has already conducted reduction and prevention activities in the area of investigation.”

Zika, which can cause a rare birth defect and other neurological conditions, has spread rapidly through the Americas. A small number of cases of Zika transmitted between sexual partners have also been documented.

There has yet to be a case of local transmission by mosquitoes in the continental United States, though more than 1,300 people in the country have reported infections after traveling to a Zika outbreak area.

U.S. officials have predicted local outbreaks to begin as the weather warms, particularly in southern states such as Florida and Texas.

(Reporting by Michele Gershberg in New York; Editing by Matthew Lewis and Bernard Orr)

U.S. GMO food labeling bill passes Senate

A customer picks up produce near a sign supporting a ballot initiative in Washington state that would require labelling of foods containing genetically modified crops at the Central Co-op in Seattle, Washington October 29, 2013. REUTERS/Jason Redmond

By Chris Prentice

(Reuters) – The U.S. Senate on Thursday approved legislation that would for the first time require food to carry labels listing genetically-modified ingredients, which labeling supporters say could create loopholes for some U.S. crops.

The Senate voted 63-30 for the bill that would display GMO contents with words, pictures or a bar code that can be scanned with smartphones. The U.S. Agriculture Department (USDA) would decide which ingredients would be considered genetically modified.

The measure now goes to the House of Representatives, where it is expected to pass.

Drawing praise from farmers, the bill sponsored by Republican Senator Pat Roberts of Kansas and Democrat Senator Debbie Stabenow of Michigan is the latest attempt to introduce a national standard that would override state laws, including Vermont’s that some say is more stringent, and comes amid growing calls from consumers for greater transparency.

“This bipartisan bill ensures that consumers and families throughout the United States will have access, for the first time ever, to information about their food through a mandatory, nationwide label for food products with GMOs,” Stabenow said in a statement.

A nationwide standard is favored by the food industry, which says state-by-state differences could inflate costs for labeling and distribution. But mandatory GMO labeling of any kind would still be seen as a loss for Big Food, which has spent millions lobbying against it.

Farmers lobbied against the Vermont law, worrying that labeling stigmatizes GMO crops and could hurt demand for food containing those ingredients, but have applauded this law.

Critics like Senator Bernie Sanders, an independent from Vermont, say the bill’s vague language and allowance for electronic labels for scanning could limit its scope and create confusion.

“When parents go to the store and purchase food, they have the right to know what is in the food their kids are going to be eating,” Sanders said on the floor of the Senate ahead of the vote.

He said at a news conference this week that major food manufacturers have already begun labeling products with GMO ingredients to meet the new law in his home state.

Another opponent of the bill, Democratic Senator Jeff Merkley of Oregon, said it would institute weak federal requirements making it virtually impossible for consumers to access information about GMOs.

LOOPHOLES

Food ingredients like beet sugar and soybean oil, which can be derived from genetically-engineered crops but contain next to no genetic material by the time they are processed, may not fall under the law’s definition of a bioengineered food, critics say.

GMO corn may also be excluded thanks to ambiguous language, some said.

The U.S. Food and Drug Administration (FDA) raised concerns about the involvement of the USDA in a list of worries sent in a June 27 memo to the Senate Agriculture Committee.

In a letter to Stabenow last week, the USDA’s general counsel tried to quell those worries, saying it would include commercially-grown GMO corn, soybeans, sugar and canola crops.

The vast majority of corn, soybeans and sugar crops in the United States are produced from genetically-engineered seeds. The domestic sugar market has been strained by rising demand for non-GMO ingredients like cane sugar.

The United States is the world’s largest market for foods made with genetically altered ingredients. Many popular processed foods are made with soybeans, corn and other biotech crops whose genetic traits have been manipulated, often to make them resistant to insects and pesticides.

“It’s fair to say that it’s not the ideal bill, but it is certainly the bill that can pass, which is the most important right now,” said American Soybean Association’s (ASA) director of policy communications Patrick Delaney.

The association was part of the Coalition for Safe and Affordable Food, which lobbied for what labeling supporters termed the Deny Americans the Right to Know, or DARK Act, that would have made labeling voluntary. It was blocked by the Senate in March.

(Reporting by Chris Prentice in New York; Additional reporting by Karl Plume in Chicago, Lisa Baertlein in Los Angeles and Kouichi Shirayanagi and Eric Beech in Washington; Editing by Marguerita Choy and Ed Davies)