‘Bloodless’ Lung Transplants for Jehovah’s Witnesses

Eric Kayne for The New York Times

SHARING HOME AND FAITH A Houston couple hosted Gene and Rebecca Tomczak, center, in October so she could get care nearby.

HOUSTON — Last April, after being told that only a transplant could save her from a fatal lung condition, Rebecca S. Tomczak began calling some of the top-ranked hospitals in the country.

She started with Emory University Hospital in Atlanta, just hours from her home near Augusta, Ga. Then she tried Duke and the University of Arkansas and Johns Hopkins. Each advised Ms. Tomczak, then 69, to look somewhere else.

The reason: Ms. Tomczak, who was baptized at age 12 as a Jehovah’s Witness, insisted for religious reasons that her transplant be performed without a blood transfusion. The Witnesses believe that Scripture prohibits the transfusion of blood, even one’s own, at the risk of forfeiting eternal life.

Given the complexities of lung transplantation, in which transfusions are routine, some doctors felt the procedure posed unacceptable dangers. Others could not get past the ethics of it all. With more than 1,600 desperately ill people waiting for a donated lung, was it appropriate to give one to a woman who might needlessly sacrifice her life and the organ along with it?

By the time Ms. Tomczak found Dr. Scott A. Scheinin at The Methodist Hospital in Houston last spring, he had long since made peace with such quandaries. Like a number of physicians, he had become persuaded by a growing body of research that transfusions often pose unnecessary risks and should be avoided when possible, even in complicated cases.

By cherry-picking patients with low odds of complications, Dr. Scheinin felt he could operate almost as safely without blood as with it. The way he saw it, patients declined lifesaving therapies all the time, for all manner of reasons, and it was not his place to deny care just because those reasons were sometimes religious or unconventional.

“At the end of the day,” he had resolved, “if you agree to take care of these patients, you agree to do it on their terms.”

Ms. Tomczak’s case — the 11th so-called bloodless lung transplant attempted at Methodist over three years — would become the latest test of an innovative approach that was developed to accommodate the unique beliefs of the world’s eight million Jehovah’s Witnesses but may soon become standard practice for all surgical patients.

Unlike other patients, Ms. Tomczak would have no backstop. Explicit in her understanding with Dr. Scheinin was that if something went terribly wrong, he would allow her to bleed to death. He had watched Witness patients die before, with a lifesaving elixir at hand.

Ms. Tomczak had dismissed the prospect of a transplant for most of the two years she had struggled with sarcoidosis, a progressive condition of unknown cause that leads to scarring in the lungs. The illness forced her to quit a part-time job with Nielsen, the market research firm.

Then in April, on a trip to the South Carolina coast, she found that she was too breathless to join her frolicking grandchildren on the beach. Tethered to an oxygen tank, she watched from the boardwalk, growing sad and angry and then determined to reclaim her health.

“I wanted to be around and be a part of their lives,” Ms. Tomczak recalled, dabbing at tears.

She knew there was danger in refusing to take blood. But she thought the greater peril would come from offending God.

“I know,” she said, “that if I did anything that violates Jehovah’s law, I would not make it into the new system, where he’s going to make earth into a paradise. I know there are risks. But I think I am covered.”

Cutting Risks, and Costs

The approach Dr. Scheinin would use — originally called “bloodless medicine” but later re-branded as “patient blood management” — has been around for decades. His mentor at Methodist, Dr. Denton A. Cooley, the renowned cardiac pioneer, performed heart surgery on hundreds of Witnesses starting in the late 1950s. The first bloodless lung transplant, at Johns Hopkins, was in 1996.

But nearly 17 years later, the degree of difficulty for such procedures remains so high that Dr. Scheinin and his team are among the very few willing to attempt them.

In 2009, after analyzing Methodist’s own data, Dr. Scheinin became convinced that if he selected patients carefully, he could perform lung transplants without transfusions. Hospital administrators resisted at first, knowing that even small numbers of deaths could bring scrutiny from federal regulators.

“My job is to push risk away,” said Dr. A. Osama Gaber, the hospital’s director of transplantation, “so I wasn’t really excited about it. But the numbers were very convincing.”

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DealBook: J. Crew Chief and American Express Invest in Warby Parker

Warby Parker, the hip purveyor of retro-style glasses, has solidified ties with two of its most prominent fans.

Now the three-year-old start-up can count Millard S. Drexler, the chief executive of J. Crew, and American Express as participants in its latest round of financing, which closed last month at $41.5 million.

The two join an already expansive group of investors that includes General Catalyst Partners, Spark Capital, Tiger Global Management, Thrive Capital and Menlo Ventures.

The presence of Mr. Drexler and American Express highlights the growing popularity of Warby Parker, whose founders created the online glasses seller in their spare time at the Wharton School of the University of Pennsylvania and quickly struggled to meet consumer demand.

Company executives first closed the round last September at $37.5 million, but left some room and time for select investors to come in as well.

“We’ve tried to be very deliberate in getting people with specific expertise,” Neil Blumenthal, one of Warby Parker’s founders, said in an interview. “Nobody knows retail like Mickey. And within financial services, nobody knows a brand more prominent than American Express.”

Mr. Blumenthal and another founder, David Gilboa, declined to comment on the valuation that the round is based on. But they said that their investors consider the retailer a lifestyle brand, which commands a higher value than an e-commerce company.

Since its founding, Warby Parker has shown significant potential in its business: selling prescription glasses and now sunglasses almost exclusively online at relatively low costs. The company has emphasized customer service by allowing prospective buyers to try on several frames before buying, and using Facebook and Twitter as ways to keep in touch with customers.

Its growth over the last three years has been largely through word of mouth, with the company having run its first television ads this year.

The company has drawn the attention of investors who hope it is less an e-commerce platform and more a brand poised to become the next Tory Burch. Such has been the demand that Silicon Valley venture capitalists regularly flew to New York to beg the founders for breakfast — and then a chance to invest.

“They treat clients like relationships,” Joel Cutler, a founder of General Catalyst, said of Warby Parker’s management. “They’re very much oriented toward telling people about a lifestyle they want to associate with.”

Among those believers is Mr. Drexler, whose successes at Gap and then J. Crew have elevated him to a wise man of retail. He began having regular lunches with Warby Parker’s founders to chat about their retail ideas.

By the time the company began raising its series B round of financing, company executives wanted stronger ties with Mr. Drexler, their informal coach.

“He was excited about some of the exciting retail stuff we were doing,” Mr. Blumenthal said. “When it was time to raise money, we wanted to get him formally involved.”

American Express has been a supporter for some time as well. The firm’s vice chairman, Edward Gilligan, invited Warby Parker executives to speak to employees early in the start-up’s life. The financial services titan also is sponsoring Warby Parker’s “Class Trip,” a cross-country promotional tour aboard a lavishly furnished yellow school bus.

While Warby Parker is collaborating with American Express on its Sync program, which offers rebates to Twitter users, there are no similar plans yet to work with J. Crew on retail partnerships, Mr. Blumenthal said. The emphasis remains on selling directly to consumers.

But the company is looking to raise its profile even more. It has been working with the Standard line of hotels on programs like artists-in-residence and a seaplane ferry from downtown Manhattan to the Hamptons.

It is also in talks with Google on providing stylish options for the tech giant’s computerized glasses product, according to people briefed on the matter.

“We really feel like we’re in an inflection point,” Mr. Gilboa of Warby Parker said. “We feel like we have a really solid foundation for the brand.”

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Paroled sex offenders disarming tracking devices

SACRAMENTO — Thousands of paroled child molesters, rapists and other high-risk sex offenders in California are removing or disarming their court-ordered GPS tracking devices — and some have been charged with new crimes including sexual battery, kidnapping and attempted manslaughter.

The offenders have discovered that they can disable the monitors, often with little risk of serving time for it, a Times investigation has found. The jails are too full to hold them.

"It's a huge problem," said Fresno parole agent Matt Hill. "If the public knew, they'd be shocked."

More than 3,400 arrest warrants for GPS tamperers have been issued since October 2011, when the state began referring parole violators to county jails instead of returning them to its packed prisons. Warrants increased 28% in 2012 compared to the 12 months before the change in custody began. Nearly all of the warrants were for sex offenders, who are the vast majority of convicts with monitors, and many were for repeat violations.

The custody shift is part of Gov. Jerry Brown and the legislature's "realignment" program, to comply with court orders to reduce overcrowding in state prisons. But many counties have been under their own court orders to ease crowding in their jails.

Some have freed parole violators within days, or even hours, of arrest rather than keep them in custody. Some have refused to accept them at all.

Before prison realignment took effect, sex offenders who breached parole remained behind bars, awaiting hearings that could send them back to prison for up to a year. Now, the maximum penalty is 180 days in jail, but many never serve that time.

With so little deterrent, parolees "certainly are feeling more bold," said Jack Wallace, an executive at the California Sex Offender Management Board.

Rithy Mam, a convicted child stalker, was arrested three times in two months after skipping parole and was freed almost immediately each time. After his third release, his GPS alarm went off and he vanished, law enforcement records show.

The next day, he turned up in a Stockton living room where a 15-year-old girl was asleep on the couch, police said. The girl told police she awoke to find the stranger staring at her and that he asked "Wanna date?" before leaving the home.

Police say Mam went back twice more that week and menaced the girl and her 13-year-old sister, getting in by giving candy to a toddler, before authorities recaptured him in a local park. He is in custody on new charges of child molestation.

Californians voted in 2006 to require that high-risk sex offenders be tracked for life with GPS monitors strapped to their bodies.

The devices are programmed to record offenders' movements and are intended, at least in part, to deter them from committing crimes. The devices, attached to rubber ankle straps embedded with fiber-optic cable, transmit signals monitored by a private contractor.

They are easy to cut off, but an alarm is triggered when that happens, as it is when they are interfered with in other ways or go dead, or when an offender enters a forbidden area such as a school zone or playground. The monitoring company alerts parole agents by text message or email.

Arrest warrants for GPS tamperers are automatically published online. The Times reviewed that data as well as thousands of jail logs, court documents and criminal histories provided by confidential sources. The records show that the way authorities handle violators can vary significantly by county.

San Bernardino County releases more inmates early from its cramped jails than any other county in California, according to state reports. But sex offenders who violate parole there generally serve their terms. A spokeswoman said the county closely reviews criminal histories, and those with past sex offenses are ineligible for early release.

By contrast, parole violators in San Joaquin County are often set free within a day of arrest.

A review of the county's jail logs shows that nine of the 15 sex offenders arrested for violating parole in December and January were let out within 24 hours, including seven who immediately tampered with their trackers and disappeared. One of the nine, a convicted rapist named Robert Stone, was arrested two weeks later on kidnapping charges and returned to jail, where he remains.

Raoul Leyva, a sex offender with a history of beating women, was arrested in April for fleeing parole and ordered to remain jailed for 100 days. He was out in 16 days and soon bolted again, after allowing the battery on his device to go dead, according to the documents reviewed by The Times.

Less than two weeks later, a drug dealer led police to a Stockton apartment where Leyva's girlfriend, 20-year-old Brandy Arreola, had lain for days on the floor, severely beaten and in a coma. Now brain damaged and confined to a wheelchair, Arreola spends her time watching cartoons.

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Wired Space Photo of the Day: Glowing Gas in Omega Nebula

This image is a colour composite of the Omega Nebula (M 17) made from exposures from the Digitized Sky Survey 2 (DSS2). The field of view is approximatelly 4.7 x 3.7 degrees.

Image: ESO/Digitized Sky Survey 2. Acknowledgment: Davide De Martin. [high-resolution]

Caption: ESO

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Relativity Moves ‘Turkeys’ Up a Year; Amy Poehler Joins Voice Cast (Exclusive)

NEW YORK (TheWrap.com) – Relativity Media has moved up its animated film “Turkeys” by a year and will release it November 1, multiple individuals close to the project told TheWrap. In addition, Amy Poehler has joined the voice cast for the film, which Relativity and Reel FX are co-producing and co-financing, TheWrap has learned.

The movie had been scheduled to debut November 14, 2014, but Relativity and Reel FX made the aggressive scheduling move based on early footage, according to two of those individuals. Development on the project began in June 2009 and physical production began in January 2011.

Poehler, who joins Owen Wilson and Woody Harrelson, will voice the female lead.

Executives at the studio met about the film this week, weighing the challenges the move will pose to the filmmaking, marketing, sponsorship and merchandising teams with the opportunity to seize this Thanksgiving’s family market.

DreamWorks Animation recently moved “Mr. Peabody & Sherman” from November 1 to March 2014, opening the door for kid-friendly fare before the November 22 opening of “The Hunger Games: Catching Fire.” Most of the other movies scheduled for October and November will cater to more mature audiences, spanning genres like science fiction (“Gravity,” “Ender’s Game”), horror (“Paranormal Activity 5,” “Carrie”) and action (“Malavita,” “Thor: The Dark World”).

Jeffrey Katzenberg‘s animation house has released a movie in the fall for eight of the last nine years, but its new distribution partner, Fox, moved “Peabody” to March, a month when the studio has had prior success with the “Ice Age” franchise.

DreamWorks Animation had a costly miss last November with “Rise of the Guardians,” which grossed $ 301 million at the box office – a healthy sum, but not enough to cover costs. The company is expected to take a hefty write-down as a result in its upcoming fourth quarter earnings.

Reel FX, the Dallas-based animation and visual effects studio behind “Turkeys,” actually sold “Guardians” to DWA five years ago.

“Turkeys” features the voices of Wilson and Harrelson as two spunky birds that take a time machine back to the first Thanksgiving. They want to expunge turkeys from Thanksgiving’s culinary tradition. Lesley Nicol of “Downton Abbey,” George Takei of “Star Trek” fame, Keith David and Colm Meaney have also been cast. Dan Fogler was already lending his voice.

Jimmy Hayward is directing the film from a script by Craig Mazin, David I. Stern, John J. Strauss.

Movies News Headlines – Yahoo! News

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The Texas Tribune: Advocates Seek Mental Health Changes, Including Power to Detain

Matt Rainwaters for Texas Monthly

The Sherman grave of Andre Thomas’s victims.

SHERMAN — A worried call from his daughter’s boyfriend sent Paul Boren rushing to her apartment on the morning of March 27, 2004. He drove the eight blocks to her apartment, peering into his neighbors’ yards, searching for Andre Thomas, Laura Boren’s estranged husband.

Expanded coverage of Texas is produced by The Texas Tribune, a nonprofit news organization. To join the conversation about this article, go to texastribune.org.

For more articles on mental health and criminal justice in Texas, as well as a timeline of the Andre Thomas case: texastribune.org

Matt Rainwaters for Texas Monthly

Laura Boren

He drove past the brightly colored slides, swings and bouncy plastic animals in Fairview Park across the street from the apartment where Ms. Boren, 20, and her two children lived. He pulled into a parking spot below and immediately saw that her door was broken. As his heart raced, Mr. Boren, a white-haired giant of a man, bounded up the stairwell, calling out for his daughter.

He found her on the white carpet, smeared with blood, a gaping hole in her chest. Beside her left leg, a one-dollar bill was folded lengthwise, the radiating eye of the pyramid facing up. Mr. Boren knew she was gone.

In a panic, he rushed past the stuffed animals, dolls and plastic toys strewn along the hallway to the bedroom shared by his two grandchildren. The body of 13-month-old Leyha Hughes lay on the floor next to a blood-spattered doll nearly as big as she was.

Andre Boren, 4, lay on his back in his white children’s bed just above Leyha. He looked as if he could have been sleeping — a moment away from revealing the toothy grin that typically spread from one of his round cheeks to the other — except for the massive chest wound that matched the ones his father, Andre Thomas (the boy was also known as Andre Jr.), had inflicted on his mother and his half-sister as he tried to remove their hearts.

“You just can’t believe that it’s real,” said Sherry Boren, Laura Boren’s mother. “You’re hoping that it’s not, that it’s a dream or something, that you’re going to wake up at any minute.”

Mr. Thomas, who confessed to the murders of his wife, their son and her daughter by another man, was convicted in 2005 and sentenced to death at age 21. While awaiting trial in 2004, he gouged out one of his eyes, and in 2008 on death row, he removed the other and ate it.

At least twice in the three weeks before the crime, Mr. Thomas had sought mental health treatment, babbling illogically and threatening to commit suicide. On two occasions, staff members at the medical facilities were so worried that his psychosis made him a threat to himself or others that they sought emergency detention warrants for him.

Despite talk of suicide and bizarre biblical delusions, he was not detained for treatment. Mr. Thomas later told the police that he was convinced that Ms. Boren was the wicked Jezebel from the Bible, that his own son was the Antichrist and that Leyha was involved in an evil conspiracy with them.

He was on a mission from God, he said, to free their hearts of demons.

Hospitals do not have legal authority to detain people who voluntarily enter their facilities in search of mental health care but then decide to leave. It is one of many holes in the state’s nearly 30-year-old mental health code that advocates, police officers and judges say lawmakers need to fix. In a report last year, Texas Appleseed, a nonprofit advocacy organization, called on lawmakers to replace the existing code with one that reflects contemporary mental health needs.

“It was last fully revised in 1985, and clearly the mental health system has changed drastically since then,” said Susan Stone, a lawyer and psychiatrist who led the two-year Texas Appleseed project to study and recommend reforms to the code. Lawmakers have said that although the code may need to be revamped, it will not happen in this year’s legislative session. Such an undertaking requires legislative studies that have not been conducted. But advocates are urging legislators to make a few critical changes that they say could prevent tragedies, including giving hospitals the right to detain someone who is having a mental health crisis.

From the time Mr. Thomas was 10, he had told friends he heard demons in his head instructing him to do bad things. The cacophony drove him to attempt suicide repeatedly as an adolescent, according to court records. He drank and abused drugs to try to quiet the noise.

bgrissom@texastribune.org

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Major Banks Aid in Payday Loans Banned by States

Major banks have quickly become behind-the-scenes allies of Internet-based payday lenders that offer short-term loans with interest rates sometimes exceeding 500 percent.

With 15 states banning payday loans, a growing number of the lenders have set up online operations in more hospitable states or far-flung locales like Belize, Malta and the West Indies to more easily evade statewide caps on interest rates.

While the banks, which include giants like JPMorgan Chase, Bank of America and Wells Fargo, do not make the loans, they are a critical link for the lenders, enabling the lenders to withdraw payments automatically from borrowers’ bank accounts, even in states where the loans are banned entirely. In some cases, the banks allow lenders to tap checking accounts even after the customers have begged them to stop the withdrawals.

“Without the assistance of the banks in processing and sending electronic funds, these lenders simply couldn’t operate,” said Josh Zinner, co-director of the Neighborhood Economic Development Advocacy Project, which works with community groups in New York.

The banking industry says it is simply serving customers who have authorized the lenders to withdraw money from their accounts. “The industry is not in a position to monitor customer accounts to see where their payments are going,” said Virginia O’Neill, senior counsel with the American Bankers Association.

But state and federal officials are taking aim at the banks’ role at a time when authorities are increasing their efforts to clamp down on payday lending and its practice of providing quick money to borrowers who need cash.

The Federal Deposit Insurance Corporation and the Consumer Financial Protection Bureau are examining banks’ roles in the online loans, according to several people with direct knowledge of the matter. Benjamin M. Lawsky, who heads New York State’s Department of Financial Services, is investigating how banks enable the online lenders to skirt New York law and make loans to residents of the state, where interest rates are capped at 25 percent.

For the banks, it can be a lucrative partnership. At first blush, processing automatic withdrawals hardly seems like a source of profit. But many customers are already on shaky financial footing. The withdrawals often set off a cascade of fees from problems like overdrafts. Roughly 27 percent of payday loan borrowers say that the loans caused them to overdraw their accounts, according to a report released this month by the Pew Charitable Trusts. That fee income is coveted, given that financial regulations limiting fees on debit and credit cards have cost banks billions of dollars.

Some state and federal authorities say the banks’ role in enabling the lenders has frustrated government efforts to shield people from predatory loans — an issue that gained urgency after reckless mortgage lending helped precipitate the 2008 financial crisis.

Lawmakers, led by Senator Jeff Merkley, Democrat of Oregon, introduced a bill in July aimed at reining in the lenders, in part, by forcing them to abide by the laws of the state where the borrower lives, rather than where the lender is. The legislation, pending in Congress, would also allow borrowers to cancel automatic withdrawals more easily. “Technology has taken a lot of these scams online, and it’s time to crack down,” Mr. Merkley said in a statement when the bill was introduced.

While the loans are simple to obtain — some online lenders promise approval in minutes with no credit check — they are tough to get rid of. Customers who want to repay their loan in full typically must contact the online lender at least three days before the next withdrawal. Otherwise, the lender automatically renews the loans at least monthly and withdraws only the interest owed. Under federal law, customers are allowed to stop authorized withdrawals from their account. Still, some borrowers say their banks do not heed requests to stop the loans.

Ivy Brodsky, 37, thought she had figured out a way to stop six payday lenders from taking money from her account when she visited her Chase branch in Brighton Beach in Brooklyn in March to close it. But Chase kept the account open and between April and May, the six Internet lenders tried to withdraw money from Ms. Brodsky’s account 55 times, according to bank records reviewed by The New York Times. Chase charged her $1,523 in fees — a combination of 44 insufficient fund fees, extended overdraft fees and service fees.

For Subrina Baptiste, 33, an educational assistant in Brooklyn, the overdraft fees levied by Chase cannibalized her child support income. She said she applied for a $400 loan from Loanshoponline.com and a $700 loan from Advancemetoday.com in 2011. The loans, with annual interest rates of 730 percent and 584 percent respectively, skirt New York law.

Ms. Baptiste said she asked Chase to revoke the automatic withdrawals in October 2011, but was told that she had to ask the lenders instead. In one month, her bank records show, the lenders tried to take money from her account at least six times. Chase charged her $812 in fees and deducted over $600 from her child-support payments to cover them.

“I don’t understand why my own bank just wouldn’t listen to me,” Ms. Baptiste said, adding that Chase ultimately closed her account last January, three months after she asked.

A spokeswoman for Bank of America said the bank always honored requests to stop automatic withdrawals. Wells Fargo declined to comment. Kristin Lemkau, a spokeswoman for Chase, said: “We are working with the customers to resolve these cases.” Online lenders say they work to abide by state laws.

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Genetically modified foods: Who has to tell?

Consumers who believe they have a right to know whether their food contains genetically modified ingredients are pressing lawmakers, regulators and voters to require labels on altered foods. But even if they succeed, experts say there's no guarantee that labels identifying genetically engineered foods would ever appear on packages.

"People are usually surprised to learn that there is no legal right to know," said Michael Rodemeyer, an expert on biotechnology policy at the University of Virginia in Charlottesville.

A variety of rules and regulations control the words that appear on food packages. Such rules must be balanced against companies' constitutionally protected right of commercial speech, experts said.

"It's an unsettled area in the law," said Hank Greely, director of the Stanford Center for Law and the Biosciences in Palo Alto. "If I were a betting man, I think the odds are good that the Supreme Court would ... strike down a GMO labeling requirement."

Consumers do have the right to know some things about foods, and it's the job of the Food and Drug Administration to enforce the various rules. Labels must carry an accurate name for the food, as well as its weight and manufacturer, a list of ingredients and, since 1990, that panel of calories and breakdown of basic nutrients that some people pore over and others blithely ignore.

And labels cannot be false or misleading. Consumers have a right to know that a product contains the nutrients they'd reasonably expect to find in a food with that name: An orange lacking vitamin C (should anyone desire to create such a thing) would have to be labeled as such.

They also have the right to know when a food contains something new that makes it materially different, such as an allergen or unexpected nutrient. Soybean varieties that are genetically engineered to contain high amounts of the monounsaturated fat oleic acid must bear labels that make that property clear, said FDA spokesperson Morgan Liscinsky.

But there is no requirement that food producers use those labels to say how they raised those oleic acid levels, according to the FDA. They could have done it through conventional breeding or by irradiating plant tissue to create mutations or by fusing cells together in a dish — or with genetic engineering.

When Flavr Savr tomatoes became the first genetically modified plants sold in supermarkets in 1994, they had stickers that informed shoppers that they were "made from genetically engineered seeds." Calgene Inc., the company that produced the tomatoes, even provided brochures and a toll-free number that consumers could call to learn more about the product, said Belinda Martineau, a geneticist at UC Davis who worked at Calgene in the 1990s.

But those labels were there only because Calgene decided to put them there. The FDA had scrutinized the process by which the company engineered the DNA in the tomatoes and decided that the technology itself didn't amount to a material change. Regulators concluded that Flavr Savr had the appearance, nutrients, flavor and texture of a tomato (although not, as it turned out, an especially tasty one).

"It was still a tomato," said Fred Degnan, a food lawyer with the firm King & Spalding in Washington, D.C., who has worked on biotechnology and labeling issues at the FDA. "They couldn't require it to be labeled in a way that implied it was different from a regular tomato."

Courts have ruled that forcing companies to label GM products violates their 1st Amendment right of free speech. In a 1996 case, a federal appeals court blocked a Vermont law that required dairy producers to label milk from cows that had been treated with a growth hormone made by genetically engineered bacteria. The hormone helped cows produce more milk, but the milk itself was the same as milk from untreated cows, the FDA determined. Because the law required labels to contain information that wasn't "material" to the product, it was unconstitutional, the 2nd Circuit Court of Appeals ruled in a 2-1 decision.

Labels can be required only if they alert consumers to a change that affects a food's composition or nutrition, its physical properties (such as shelf life), or the qualities that influence the sensory experience of smelling, tasting and eating it, the FDA says.

It is not a definition that sits well with all.

Andrew Kimbrell, executive director of the Washington-based advocacy group Center for Food Safety, said that approach reflects "19th century science." His group has petitioned the FDA to update its rules so that any product created via genetic engineering would be considered altered enough to require a label.

Such a change would also give companies more leeway to label their products as free of genetically modified ingredients: Today they can do so only if the label doesn't imply that there's something wrong with GM foods or that GMO-free foods are superior (although many companies skirt the rules).

"We need to know we have an agency using 21st century regulations to deal with 21st century technology," Kimbrell said.

The FDA's stance on labeling genetically modified foods differs starkly from that of European regulators, who require foods with genetically engineered ingredients to bear labels. Most scientists believe that the FDA's approach is rational — but perhaps it's too rational if the goal is to encourage public acceptance of the technology, said Jennifer Kuzma, a science policy expert at the Humphrey School of Public Affairs at the University of Minnesota.

"This is something that people want to see on labels," Kuzma said. "My view is that consumers deserve a choice when it comes to something that is important to them, even though there may not be a scientific basis for doing it."

Rodemeyer, the expert on biotechnology policy, says he thinks food producers made a tactical mistake by deciding not to label their genetically modified products voluntarily.

"When you don't label, you're always raising suspicion you're trying to hide something," he said.

Since most processed foods contain oil, sugar, syrups, emulsifiers, flour, cornmeal and protein that are derived from GM crops, virtually every product sold in the last 15 years would have carried a label. By now, those labels would have lost all meaning, Rodemeyer said: "If they would have all held their noses and jumped together, this wouldn't be an issue."

science@latimes.com

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That Syncing Feeling

“Smart, or stylish?” That’s the question facing casual watch aficionados looking for a new, high-tech addition to their collection.

On one hand (er, wrist), you’ve got the Pebble and other smartwatch upstarts, which come with built-in smartphone connectivity, customizable screens, and burgeoning developer communities eager to feed their app ecosystems. They also, by and large, look like uninspired pieces of mass-produced Chinese plastic, and that’s because they are.

On the “stylish” end of the spectrum is … not much. Except this: Citizen’s Eco-Drive Proximity.

The Citizen learns the current time from your phone, and the watch’s hands spin around to the correct positions.

By all outward appearances, the Proximity looks like any another chronograph in a sea of handsome mechanical watches. It has all the features you’d expect, including a 24-hour dial, day and date, perpetual calendar and second time zone. But housed within its slightly oversized 46mm case is a Bluetooth 4.0 radio, so it’s capable of passing data over the new low-energy connectivity standard appearing in newer smartphones, including the iPhone 5 and 4S. And for now, the Promixity is only compatible with those Apple devices.

Initial pairing is relatively easy. After downloading Citizen’s notably low-rent iOS app, you can link the watch to your phone with a few turns and clicks on the crown.

The gee-whiz feature is the automatic time sync that takes place whenever you land in a different time zone. Once connected, the Citizen learns the current time from your phone, and the watch’s hands spin around to the correct positions — a welcome bit of easy magic, considering the initial setup is a tedious finger dance.

The watch can also notify you of incoming communications. Once you’ve configured the mail client (it only supports IMAP accounts), you’ll get notified whenever you get a new e-mail — there’s a slight vibration and the second hand sweeps over to the “mail” tab at the 10-o’clock position. If a phone call comes in, the second hand moves to the 11-o’clock marker. If the Bluetooth connection gets lost because the watch or phone is outside the 30-foot range, you get another vibration and the second hand moves to the “LL” indicator. And really, that’s the extent of the functionality around notifications.

But notable in its absence is the notification I’d like the most: text message alerts. And it’s not something Citizen will soon be rectifying because the dials and hardware aren’t upgradable.

I also experienced frequent connection losses, particularly when attending a press conference with scads of Mi-Fis and tethered smartphones around me. This caused dozens of jarring vibrations both on my wrist and in my pocket, followed by a raft of push notifications on my phone informing me of the issue. Reconnecting is easy (and generally happens automatically), but the lack of stability in certain environments matched with the limited capabilities of the notifications had me forgetting to reconnect and not even worrying about it later on.

But actually, I’m OK with that. I still like the fact that it never needs charging. Even though there aren’t any solar cells visible on the dial, the watch does have them. They’re hidden away beneath the dial, and yet they still work perfectly. And even when its flagship connectivity features aren’t behaving, it’s still a damn handsome watch. It feels solid, and it looks good at the office, out to dinner, or on the weekend — something very few other “smart” watches on the market can claim.

However, those things can be said of almost all of Citizen’s EcoDrive watches. The big distinguishing feature here is the Bluetooth syncing and notifications, and they just don’t work that well.

WIRED A smart watch you won’t be embarrassed to wear. Charges using light. Combines classic styling with cutting-edge connectivity. Subtle notifications keep you informed without dominating your attention.

TIRED Loses Bluetooth connection with disturbing frequency. Limited notification abilities. No text message alerts. Janky iPhone app.

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Drone Pilots Found to Get Stress Disorders Much as Those in Combat Do

U.S. Air Force/Master Sgt. Steve Horton

Capt. Richard Koll, left, and Airman First Class Mike Eulo monitored a drone aircraft after launching it in Iraq.

The study affirms a growing body of research finding health hazards even for those piloting machines from bases far from actual combat zones.

“Though it might be thousands of miles from the battlefield, this work still involves tough stressors and has tough consequences for those crews,” said Peter W. Singer, a scholar at the Brookings Institution who has written extensively about drones. He was not involved in the new research.

That study, by the Armed Forces Health Surveillance Center, which analyzes health trends among military personnel, did not try to explain the sources of mental health problems among drone pilots.

But Air Force officials and independent experts have suggested several potential causes, among them witnessing combat violence on live video feeds, working in isolation or under inflexible shift hours, juggling the simultaneous demands of home life with combat operations and dealing with intense stress because of crew shortages.

“Remotely piloted aircraft pilots may stare at the same piece of ground for days,” said Jean Lin Otto, an epidemiologist who was a co-author of the study. “They witness the carnage. Manned aircraft pilots don’t do that. They get out of there as soon as possible.”

Dr. Otto said she had begun the study expecting that drone pilots would actually have a higher rate of mental health problems because of the unique pressures of their job.

Since 2008, the number of pilots of remotely piloted aircraft — the Air Force’s preferred term for drones — has grown fourfold, to nearly 1,300. The Air Force is now training more pilots for its drones than for its fighter jets and bombers combined. And by 2015, it expects to have more drone pilots than bomber pilots, although fighter pilots will remain a larger group.

Those figures do not include drones operated by the C.I.A. in counterterrorism operations over Pakistan, Yemen and other countries.

The Pentagon has begun taking steps to keep pace with the rapid expansion of drone operations. It recently created a new medal to honor troops involved in both drone warfare and cyberwarfare. And the Air Force has expanded access to chaplains and therapists for drone operators, said Col. William M. Tart, who commanded remotely piloted aircraft crews at Creech Air Force Base in Nevada.

The Air Force has also conducted research into the health issues of drone crew members. In a 2011 survey of nearly 840 drone operators, it found that 46 percent of Reaper and Predator pilots, and 48 percent of Global Hawk sensor operators, reported “high operational stress.” Those crews cited long hours and frequent shift changes as major causes.

That study found the stress among drone operators to be much higher than that reported by Air Force members in logistics or support jobs. But it did not compare the stress levels of the drone operators with those of traditional pilots.

The new study looked at the electronic health records of 709 drone pilots and 5,256 manned aircraft pilots between October 2003 and December 2011. Those records included information about clinical diagnoses by medical professionals and not just self-reported symptoms.

After analyzing diagnosis and treatment records, the researchers initially found that the drone pilots had higher incidence rates for 12 conditions, including anxiety disorder, depressive disorder, post-traumatic stress disorder, substance abuse and suicidal ideation.

But after the data were adjusted for age, number of deployments, time in service and history of previous mental health problems, the rates were similar, said Dr. Otto, who was scheduled to present her findings in Arizona on Saturday at a conference of the American College of Preventive Medicine.

The study also found that the incidence rates of mental heath problems among drone pilots spiked in 2009. Dr. Otto speculated that the increase might have been the result of intense pressure on pilots during the Iraq surge in the preceding years.

The study found that pilots of both manned and unmanned aircraft had lower rates of mental health problems than other Air Force personnel. But Dr. Otto conceded that her study might underestimate problems among both manned and unmanned aircraft pilots, who may feel pressure not to report mental health symptoms to doctors out of fears that they will be grounded.

She said she planned to conduct two follow-up studies: one that tries to compensate for possible underreporting of mental health problems by pilots and another that analyzes mental health issues among sensor operators, who control drone cameras while sitting next to the pilots.

“The increasing use of remotely piloted aircraft for war fighting as well as humanitarian relief should prompt increased surveillance,” she said.

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