A Step Toward a Universal Cancer Blood Test



By Jocelyn Kaiser, ScienceNOW


People usually find out that they have cancer after developing symptoms or through a screening test such as a mammogram—signs that may appear only after the cancer has grown or spread so much that it can’t be cured. But what if you could find out from a simple, highly accurate blood test that you had an incipient tumor? By sequencing the abnormal DNA that a tumor releases into a person’s bloodstream, researchers are now one step closer to a universal cancer test. Although the technique is now only sensitive enough to detect advanced cancers, that may be a matter of money: As sequencing costs decrease, the developers of the method say, the test could eventually pick up early tumors as well.


The new work is part of a wave of research on using either cells shed into the blood by tumors or free-floating tumor DNA in blood to track the growth and spread of tumors and tailor treatments. The free tumor DNA tests generally rely on looking for known alterations in cancer genes to distinguish cancerous DNA from normal DNA. Seeking a way to detect tumor DNA without knowing its genetic makeup beforehand, postdoctoral researcher Rebecca Leary and others in the labs of Victor Velculescu and Luis Diaz at the Johns Hopkins University School of Medicine in Baltimore, Maryland, and collaborators at other institutions took advantage of an observation they and others have made: No matter the type of cancer, tumor cells almost invariably have substantially altered chromosomes, such as swapped pieces and extra copies of certain genes. This suggests that a test that could detect any chromosomal abnormalities in a person’s blood could serve as a general test for cancer.


Now, the researchers have shown that their idea has promise. First, they isolated the free DNA in blood samples from 10 people with advanced colon or breast cancer. Then, using next-generation DNA sequencing methods, they read the entire genome of the DNA in the blood. (The approach was similar to a new test that can detect Down syndrome in a fetus from a pregnant woman’s blood sample by looking for just an extra copy of chromosome 21.) The cancer patients all had DNA with chromosomal alterations in their blood, whereas none of 10 healthy controls tested positive, according to the team’s report today in Science Translational Medicine.



“There are multiple uses of this approach,” Velculescu says. His group initially hopes to track whether a patient’s tumor is responding to treatment or regrows after surgery. The test could also be used to decide what drug a patient should get without biopsying her tumor—in some patients, the Hopkins team detected extra copies of two genes known to drive cancer, ERBB2 and CDK6, which can be targeted with existing drugs.


The test isn’t that cheap or quick at the moment: Each of the 10 patients’ tests in the study cost several thousand dollars just for sequencing and took a month, including the time for analysis. And early detection is still a ways off. The technique has to sift through large amounts of DNA from normal cells that is also floating in blood to find tumor-associated sequences; the portion of DNA in the cancer patients’ blood that came from tumors ranged from 47.9% to as low as 1.4%. The test might have to work on blood samples with less than 0.1% tumor DNA to detect small, curable tumors, the researchers suggest. But that is just a matter of doing more sequencing, Velculescu says. And as sequencing costs continue to drop, “in the very near future, this could end up being extremely cheap,” he adds.


“The approach has tremendous promise and, should the sequencing strategy become economical, it could have important applications in early cancer detection,” says Daniel Haber of Massachusetts General Hospital in Boston who works on using circulating tumor cells to detect and monitor cancer.


Carlos Caldas of the Cancer Research UK Cambridge Research Institute, who, like the Hopkins group, is working on sequencing free tumor DNA in blood, says the new study is the latest showing “that circulating tumor DNA is going to have a great future in all aspects of cancer management. … This is an exploding field.” He thinks such tests could reach the clinic within 5 to 10 years.


This story provided by ScienceNOW, the daily online news service of the journal Science.


Read More..

Russian court bans “extremist” Pussy Riot video












MOSCOW (Reuters) – A Russian court ruled on Thursday that video footage of the Pussy Riot punk group protesting against President Vladimir Putin in a church was “extremist” and should be removed from websites.


The demonstration last February offended many Russian Orthodox Christians. But Putin has been criticized by U.S. and European leaders over what they saw as disproportionate jail sentences imposed on three Pussy Riot members. Their trial was also seen by Putin’s critics as part of a clampdown on dissent.












The Moscow court said it had based its ruling on conclusions by a panel of experts who studied the video, showing band members in colorful mini-skirts and ski masks dancing in front of the altar of Moscow’s main Russian Orthodox cathedral.


Judge Marina Musimovich said the footage “has elements of extremism; in particular there are words and actions which humiliate various social groups based on their religion”. She said it also had calls for mutiny and “mass disorder”.


The verdict said that free distribution of the video could ignite racial and religious hatred.


The court’s ruling applies to other videos released by the band, including a performance in Moscow’s Red Square, where calls for mass disorder could be heard. Such calls were not made inside the church.


The websites are now likely to be included in a state register and could be blocked if the banned content is not removed.


The Russian communications regulator Roskomnadzor said that once the court decision takes effect it will monitor how it is implemented.


Three members of Pussy Riot convicted in August of hooliganism motivated by religious hatred for their “punk prayer”, which the Russian Orthodox Church has cast as part of a concerted attack on the church and the faithful.


The women said the protest, in which they burst into Christ the Saviour Cathedral and called on the Virgin Mary to rid Russia of Putin, was not motivated by hatred and was meant to mock the church leadership’s support for the longtime leader.


Band members Nadezhda Tolokonnikova and Maria Alyokhina are serving two-year jail sentences over the protest last February. A third member, Yekaterina Samutsevich, walked free last month when her sentence was suspended on appeal.


“To me this is a clear attribute of censorship – censorship of art and censorship of culture, of the protest culture which is very important for any country, let alone for Russia,” Samutsevich told reporters outside court.


“Now of course the fact that they will be blocking all Pussy Riot videos as I understand, all photos – this is horrible. Naturally, I will lodge an appeal and I will try to do it today,” she added.


Putin, a former KGB officer who has cultivated close ties with the Orthodox church over 13 years in power, has rebuffed Western criticism about the prison terms meted out.


(Additional reporting Valery Stepchenkov; Editing by Mark Heinrich)


Music News Headlines – Yahoo! News


Read More..

Cost of Brand-Name Prescription Medicines Soaring





The price of brand-name prescription medicines is rising far faster than the inflation rate, while the price of generic drugs has plummeted, creating the largest gap so far between the two, according to a report published Wednesday by the pharmacy benefits manager Express Scripts.




The report tracked an index of commonly used drugs and found that the price of brand-name medicines increased more than 13 percent from September 2011 to this September, which it said was more than six times the overall price inflation of consumer goods. Generic drug prices dipped by nearly 22 percent.


The drop in the price of generics “represents low-hanging fruit for the country to save money on health care,” said Dr. Steve Miller, the chief medical officer of Express Scripts, which manages the drug benefits for employers and insurers and also runs a mail-order pharmacy.


The report was based on a random sample of six million Express Scripts members with prescription drug coverage.


The Pharmaceutical Research and Manufacturers of America, the trade group representing brand-name manufacturers, criticized the report, saying it was skewed by a handful of high-priced specialty drugs that are used by a small number of patients and overlooked the crucial role of major drug makers.


“Without the development of new medicines by innovator companies, there would be neither the new treatments essential to progress against diseases nor generic copies,” Josephine Martin, executive vice president of the group, said in a statement.


The report cited the growth of specialty drugs, which treat diseases like cancer and multiple sclerosis, as a major reason for the increase in spending on branded drugs. Spending on specialty medicines increased nearly 23 percent during the first three quarters of 2012, compared with the same period in 2011. All but one of the new medicines approved in the third quarter of this year were specialty drugs, the report found, and many of them were approved to treat advanced cancers only when other drugs had failed.


Stephen W. Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, said the potential benefits of many new drugs did not always match the lofty price tags. “Increasingly it’s going to be difficult for drug-benefit programs to make decisions about coverage and payment and which drugs to include,” said Mr. Schondelmeyer, who conducts a similar price report for AARP. He also helps manage the drug benefit program for the University of Minnesota.


“We’re going to be faced with the issue that any drug at any price will not be sustainable.”


Spending on traditional medicines — which treat common ailments like high cholesterol and blood pressure — actually declined by 0.6 percent during the period, the report found. That decline was mainly because of the patent expiration of several blockbuster drugs, like Lipitor and Plavix, which opened the market for generic competitors. But even as the entry of generic alternatives pushed down spending, drug companies continued to raise prices on their branded products, in part to squeeze as much revenue as possible out of an ever-shrinking portfolio, Dr. Miller said.


Drug makers are also being pushed by companies like Express Scripts and health insurers, which are increasingly looking for ways to cut costs, said C. Anthony Butler, a pharmaceuticals analyst at Barclays. “I think they’re pricing where they can but what they keep telling me is they’re under significant pressure” to keep prices low, he said.


Express Scripts earns higher profits from greater use of generic medicines than brand name drugs sold through their mail-order pharmacy, Mr. Butler said. “There’s no question that they would love for everybody to be on a generic,” he said.


Dr. Miller acknowledged that was true but said that ultimately, everyone wins. “When we save people money, that’s when we make money,” he said. “We don’t shy away from that.”


Read More..

Medicare Is Faulted in Electronic Medical Records Conversion





The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators.







Mike Spencer/Wilmington Star-News, via Associated Press

Celeste Stephens, a nurse, leads a session on electronic records at New Hanover Regional Medical Center in Wilmington, N.C.







Centers for Medicare and Medicaid Services

Marilyn Tavenner, acting administrator for Medicare.






The use of electronic medical records has been central to the aim of overhauling health care in America. Advocates contend that electronic records systems will improve patient care and lower costs through better coordination of medical services, and the Obama administration is spending billions of dollars to encourage doctors and hospitals to switch to electronic records to track patient care.


But the report says Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions.


Medicare “faces obstacles” in overseeing the electronic records incentive program “that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements,” the investigators concluded. The report was prepared by the Office of Inspector General for the Department of Health and Human Services, which oversees Medicare.


The investigators contrasted the looser management of the incentive program with the agency’s pledge to more closely monitor Medicare payments of medical claims. Medicare officials have indicated that the agency intends to move away from a “pay and chase” model, in which it tried to get back any money it has paid in error, to one in which it focuses on trying to avoid making unjustified payments in the first place.


Late Wednesday, a Medicare spokesman said in a statement: “Protecting taxpayer dollars is our top priority and we have implemented aggressive procedures to hold providers accountable. Making a false claim is a serious offense with serious consequences and we believe the overwhelming majority of doctors and hospitals take seriously their responsibility to honestly report their performance.”


The government’s investment in electronic records was authorized under the broader stimulus package passed in 2009. Medicare expects to spend nearly $7 billion over five years as a way of inducing doctors and hospitals to adopt and use electronic records. So far, the report said, the agency has paid 74, 317 health professionals and 1,333 hospitals. By attesting that they meet the criteria established under the program, a doctor can receive as much as $44,000 for adopting electronic records, while a hospital could be paid as much as $2 million in the first year of its adoption. The inspector general’s report follows earlier concerns among regulators and others over whether doctors and hospitals are using electronic records inappropriately to charge more for services, as reported by The New York Times last September, and is likely to fuel the debate over the government’s efforts to promote electronic records. Critics say the push for electronic records may be resulting in higher Medicare spending with little in the way of improvement in patients’ health. Thursday’s report did not address patient care.


Even those within the industry say the speed with which systems are being developed and adopted by hospitals and doctors has led to a lack of clarity over how the records should be used and concerns about their overall accuracy.


“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago. The association, which contends more study is needed to determine whether hospitals and doctors actually are abusing electronic records to increase their payments, says it supports more clarity.


Although there is little disagreement over the potential benefits of electronic records in reducing duplicative tests and avoiding medical errors, critics increasingly argue that the federal government has not devoted enough time or resources to making certain the money it is investing is being well spent.


House Republicans echoed these concerns in early October in a letter to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.


In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.” She said Medicare was trying to determine whether electronic records had been used in any fraudulent billing but she insisted that the current efforts to certify the systems and address the concerns raised by the Republicans and others were adequate.


Read More..

Norquist: GOP concern over tax pledge just 'impure thoughts'









Grover Norquist on Wednesday rebuffed claims that his anti-tax crusade is losing steam, calling statements from prominent Republicans hinting at their departure from his anti-tax pledge "impure thoughts."

Norquist, president of Americans for Tax Reform, met with Politico’s Mike Allen to offer his thoughts on the looming “fiscal cliff,” and the growing narrative that Republicans, after years of tying themselves to ATR’s pledge not to raise taxes, may be ready to jump ship.


Most recently, Rep. Tom Cole (R-Okla.) said in a private meeting with the House Republican whip team Tuesday morning that Republicans should take the opportunity to extend President George W. Bush’s tax cuts for 98% of Americans, calling it an “early Christmas present” for taxpayers.


And on Sunday, Sen. Lindsay Graham (R-S.C.) and Rep. Peter King (R-N.Y.) joined Sen. Saxby Chambliss (R-Ga.) in voicing concern over continued adherence to Norquist’s pledge.





House Speaker John A. Boehner (R-Ohio) responded to Cole on Wednesday, saying that though Cole is a friend and supporter, he disagrees entirely with his stance. “The goal here is to grow the economy and control spending. You’re not going to grow the economy if you raise tax rates on the top two rates,” Boehner said.


Though Norquist commented that Cole’s recommendation was “an interesting tactic,” he remained firm that his pledge remains viable, saying that anyone suggesting that opposing tax increases is no longer in vogue is “an idiot.”


The pledge, Norquist claimed, “takes weasel words out” of campaign promises to cut taxes, and provides voters a clear picture of a candidate's stance, a stance he said the Republican Party has built its brand upon.


Norquist said that signing the pledge is about informing voters and entrenching a preexisting policy stance, instead of an oath of fealty to ATR and its champion cause.


“They don’t need my permission to raise taxes,” he said, adding that such power lies in the hands of voters.


And he dismissed claims that the pledge’s powers extend beyond the promises tied to its concise wording.


“It doesn’t solve all of the world’s problems; it doesn’t design tax reform,” Norquist said.


But Norquist did design a general road map for Republicans to use in fiscal cliff negotiations.


“You need to have this conversation in public, you need to be online so you can have the moral higher ground,” he said, recommending that the GOP aim for a temporary extension of Bush’s tax cuts, with comprehensive tax reform to follow soon after.


“If the Republicans lose in such a way that they have their fingerprints on the murder weapon, then you have a problem,” he said, adding that public debate over the fiscal cliff would allow Republicans a chance to turn the tide against President Obama and the Democrats, so long as they maintain “credible clarity” in espousing their low-tax vision.


Norquist said he worries about conceding any ground to Democrats on tax increases.


“What the Democrats do is trickle-down taxation,” he said. “They tax the rich and then they screw everybody.”


Follow Politics Now on Twitter and Facebook





Read More..

Beyond Iron Dome: Israel Preps New Anti-Missiles, Eyes Lasers



Israel just proved that its new Iron Dome system can repel Hamas’ short-range rockets and missiles. The bad news: Those weapons are nothing compared to the more advanced missiles that Hezbollah and Iran can throw at Israel, which would surely overwhelm Iron Dome. That’s why Israel, and America, are already looking into the missile defense systems that come after Iron Dome — including ones that rely on lasers.


The Israelis can justly say their system worked better than American and Israeli skeptics (and Hamas) anticipated. Five Iron Dome batteries destroyed some 421 Qassam rockets and Iranian-made Fajr-5 missiles launched from Gaza, for an interception rate of between 80 and 90 percent. (Hamas fired over 1,500 projectiles, but Iron Dome ignores those that don’t impact populated areas.) It kept Israeli casualties far below Palestinian ones and might have convinced Prime Minister Benjamin Netanyahu he didn’t need to re-invade Gaza. All this for a cost of under $30 million per interception.


All this has Israel pumping its fist. Uzi Rubin, a former Israeli missile defense official, boasted that Iron Dome outperformed the U.S.’ Patriot missile and showcased “Jewish genius with blue and white [i.e., Israeli] technology.” (Iron Dome was jointly developed with the U.S., but whatever.) And already Rafael, the company behind Iron Dome, is pledging to up its success rate to 95 percent in the next several months as it and the Israel Defense Forces sift through the launch data.


The thing is, Hamas is peanuts. Its Qassams and Fajr-5s are unguided systems, unsophisticated compared to the missile arsenals of Hezbollah and Iran, which include ballistic missiles. Even a souped-up Iron Dome would probably be overwhelmed by those. So as encouraged as Israel is by Iron Dome’s success, it’s already scaling upward, to more powerful interceptor-based missile defenses intended to blunt a layered assault from Hamas to Hezbollah to Iran. Some, however, doubt that a bullet is the right instrument for stopping another bullet, and would prefer to use the laser weapons the U.S. is developing.



Just days after Wednesday’s ceasefire with Hamas, it prominently tested Iron Dome’s big brother, called David’s Sling (and sometimes “Magic Wand”). Whereas Iron Dome’s stated maximum range is 45 miles (and is probably shorter in reality), David’s Sling’s interceptors are designed to hit incoming missiles from up to 200 miles away. If it works as intended, David’s Sling should protect Israel against the longer-range missiles that Hezbollah possesses M600, Zelzal, other Fajr models; and perhaps even the Scud ballistic missiles Israel contends Hezbollah got from Iran or Syria.


David’s Sling and Iron Dome have another brother, the Arrow. The Arrow has been in development for years and was originally conceived of as a Scud-stopper. Like some American anti-ballistic missile systems, the Arrow family of defenses is designed to stop a ballistic missile upon re-entry into the Earth’s atmosphere — principally, Iran’s Shehab-3. Over the summer, Israel upgraded the hardware, software, sensor array, interceptors and “Green Pine” radar on the Arrow-2; and an Arrow-3 is on the horizon that can reach twice its predecessor’s altitude. That’s likely intended to blunt the impact of Iran’s forthcoming the Iranian Sejjil-2 medium-range ballistic missile.


You can think of Iron Dome as the bantamweight, David’s Sling/Magic Wand as the middleweight and the Arrow as the heavyweight. And viewed together, you can see what Israel fears: a concerted barrage from Iran and its proxies that comprises everything from unguided Qassam rockets to Sejjil-3 ballistic missiles. That scenario brought U.S. Patriot missile batteries, Aegis ships and some 3,500 troops to Israel last month for the largest joint missile-defense exercises ever between the two allies, and you might hear more on the subject on Thursday, when outgoing Defense Minister Ehud Barak visits the Pentagon.


But some think hitting a bullet with another bullet is the wrong paradigm for missile defense. One Ha’aretz writer, Reuben Pedatzur, pines for Northrop Grumman’s Skyguard chemical laser, which would burn through projectiles after picking them up on radar. In the pre-Iron Dome days, residents of southern Israel once sued the Israeli government to bring Skyguard to their communities. And it’s worth noting that on Tuesday, rival Lockheed Martin claimed its own developmental laser system, the Area Defense Anti-Munitions, shot down four “small caliber” rockets from about a mile away in recent testing.


Except that laser-based missile defenses have been promised for decades and are never quite there yet. Rubin, the former Israeli missile defense official, blasted Skyguard in Ha’aretz on Tuesday as “simply unrealistic,” noting that the U.S. doesn’t even use it in Afghanistan, where its bases are frequently rocketed. And the U.S. Navy, which has sunk a lot of money into developing laser defenses for ships, still doesn’t consider its most mature solid-state lasers ready to burn through missiles this decade.


Still, David’s Sling and the upgraded Arrow have years to go before they’re ready, and their own trials by fire might not go as well as Iron Dome’s. Meanwhile, Hezbollah is pledging to launch “thousands of rockets” if Israel attacks, and the threat of a war with Iran hasn’t abated. If Hezbollah, or Iran, follow through on that threat, Iron Dome’s limits might become as visible as its successes just were.


Read More..

Thousands celebrate Hobbit premiere in New Zealand












WELLINGTON (Reuters) – Tens of thousands of people packed New Zealand’s capital city, clambering on roofs and hanging onto lamp posts on Wednesday to get a glimpse of the stars at the red carpet world premiere of the film “The Hobbit: an Unexpected Journey”.


Wellington, where director Peter Jackson and much of the post production is based, renamed itself “the Middle of Middle Earth“, and fans with prominent Hobbit ears, medieval style costumes, and wizard hats had camped out the night before to claim prized spaces along the 500 meter (550 yards) red carpet.












Jackson, a one time newspaper printer and the maker of the Oscar winning “Lord of the Rings” trilogy more than a decade ago, was cheered along the walk, stopping to talk to fans, sign autographs and pose for photos.


The Hobbit trilogy is set 60 years before the Rings movies, but Jackson said it has benefited from being made after the conclusion of the J.R.R. Tolkien fantasy saga.


“I’m glad that we established the style and the look of Middle Earth by adapting Lord of the Rings before we did the Hobbit,” Jackson told Reuters from the red carpet.


Jackson, a hometown hero in Wellington, said the production had been on a “difficult journey”, alluding to Warner Brothers’ financial problems, and a later labor dispute with unions.


“Fate meant for us to be here,” he told an ecstatic crowd, which hailed him as a film genius, but also a down to earth local boy.


“I came here to see the stars but also Peter (Jackson)…I loved the Lord of the Rings and that made me want to be here, without him none of it would be here,” said teenage student Samantha Cooper.


OLD FRIENDS


The cast was no less enthusiastic about the Hobbit, especially those who had starred in the Lord of the Rings trilogy.


British actor Andy Serkis, who plays the creature Gollum with a distinctive throaty whisper, said picking up the character after a near-ten year break was like putting on a familiar skin.


“I was reminded on a daily basis with Gollum (that) he’s truly never left me,” he said.


Most of the film’s stars attended the premiere, including British actor Martin Freeman, who plays the Hobbit Bilbo Baggins, Andy Serkis, Hugo Weaving, Cate Blanchett, and Elijah Wood. Ian McKellen, who plays the wizard Gandalf, was absent.


Freeman, known for his roles in the comedy The Office and Sherlock Holmes, said he looked for a different, lighter, slightly pompous Baggins from the older, wiser character played by Ian Holm in the Rings movies.


“Between us – Peter (Jackson) and me — we hashed out another version of Bilbo. There’ll be others, but our version is this one and I hope people like it,” he said.


The production was at the center of several controversies, including a dispute with unions in 2010 over labor contracts that nearly sent the filming overseas and resulted in the government stepping in to change employment laws.


The only sour note at the premiere came when animal rights activists held up posters saying “Middle Earth unexpected cruelty” and “3 horses died for this film”, after claims last week that more than 20 animals died during the making of the film.


Event organizers tried to block out the protesters’ posters with large Hobbit film billboards. Jackson has said some animals died on a farm where they were housed, but none had been hurt during filming.


The movies have been filmed in 3D and at 48 frames per second (fps), compared with the standard 24 fps, which Jackson has likened to the quality leap to compact discs from vinyl records.


The second film “The Hobbit: The Desolation of Smaug” will be released in December next year, with the third “The Hobbit: There and Back Again” due in mid-July 2014.


(Editing by Elaine Lies)


Movies News Headlines – Yahoo! News


Read More..

F.D.A. May Tap Experts on Energy Drinks


The Food and Drug Administration said in a letter released on Tuesday that it was likely to seek advice from outside experts to help determine whether energy drinks posed particular risks to teenagers or people with underlying health problems.


The letter appears to signal a change in the agency’s approach to the drinks, which contain high levels of caffeine.


Previously, F.D.A. officials have said that they were investigating possible risks posed by popular products like 5-Hour Energy, Monster Energy and Red Bull. But an agency spokeswoman, Shelly Burgess, said the new letter was the first time that the F.D.A. had said it might turn to outside experts.


The F.D.A. letter, which was released Tuesday by Senator Richard J. Durbin of Illinois and Senator Richard Blumenthal of Connecticut, follows disclosures that the agency received reports of 18 deaths and over 150 injuries that mentioned the possible involvement of energy drinks.


The filing of such reports with the F.D.A. does not prove that a product was responsible for a death or an injury. Energy drink makers have said their products are safe and were not responsible for the health problems.


The officials said a review of the drinks might be “greatly enhanced by also engaging specialized expertise” from an outside group, like the Institute of Medicine, which is part of the National Academy of Sciences.


Industry analysts said the letter indicated that the F.D.A. did not plan any immediate actions on energy drinks, an interpretation that set off a rally on Tuesday in the stock of Monster Beverage, the producer of Monster Energy. Company shares closed at $51.97, up over 13 percent. Any regulatory outcome is likely to be “benign,” Judy Hong, an analyst at Goldman Sachs, said in a note to investors, according to Bloomberg News.


In Canada, however, the use of an outside panel led to limits on caffeine levels in energy drinks.


In their letter, F.D.A. officials indicated that an outside review would focus on the possible risks posed by high levels of caffeine, a stimulant, to certain groups. They reiterated that daily consumption of significant levels of caffeine, which is found in products like coffee and tea, is safe.


“Areas of particular focus would include such matters as the vulnerability of certain populations to stimulants and the incidence and consequence of excessive consumption” of energy drinks, especially by young people, F.D.A. officials wrote.


In Canada, an expert panel made several recommendations, including arguing that such beverages be labeled “stimulant drug-containing drinks.”


Health Canada, that country’s counterpart to the F.D.A., did not adopt many of the group’s recommendations, but it has put in place new rules limiting caffeine levels in cans of energy drinks to 180 milligrams.


Some larger-size cans of energy drinks sold in the United States, like the 24-ounce can of Monster Energy and the 20-ounce can of Red Bull, have caffeine levels above that limit.


An eight-ounce cup of coffee, depending on how it is made, can contain from 100 to 150 milligrams of caffeine.


In the new letter, F.D.A. officials also said that studies that had examined other ingredients, like taurine, that are often used in energy drinks had determined those substances were safe. The agency also said that a survey suggested that energy drinks constitute a small portion of the caffeine consumed in this country, even by teenagers.


Read More..

Ex-NASA Scientist’s Data Fears Come True





In 2007, Robert M. Nelson, an astronomer, and 27 other scientists at the Jet Propulsion Laboratory sued NASA arguing that the space agency’s background checks of employees of government contractors were unnecessarily invasive and violated their privacy rights.




Privacy advocates chimed in as well, contending that the space agency would not be able to protect the confidential details it was collecting.


The scientists took their case all the way to the Supreme Court only to lose last year.


This month, Dr. Nelson opened a letter from NASA telling him of a significant data breach that could potentially expose him to identity theft.


The very thing he and advocates worried about had occurred. A laptop used by an employee at NASA’s headquarters in Washington had been stolen from a car parked on the street on Halloween, the space agency said.


Although the laptop itself was password protected, unencrypted files on the laptop contained personal information on about 10,000 NASA employees — including details like their names, birth dates, Social Security numbers and in some cases, details related to background checks into employees’ personal lives.


Millions of Americans have received similar data breach notices from employers, government agencies, medical centers, banks and retailers. NASA in particular has been subject to “numerous cyberattacks” and computer thefts in recent years, according to a report from the Government Accountability Office, an agency that conducts research for Congress.


Even so, Dr. Nelson, who recently retired from the Jet Propulsion Laboratory, a research facility operated by the California Institute of Technology under a contract with NASA, stands out as a glaring example of security lapses involving personal data, privacy advocates say.


“To the extent that Robert Nelson looks like millions of other people working for firms employed by the federal government, this would seem to be a real problem,” said Marc Rotenberg, the executive director of the Electronic Privacy Information Center, an advocacy group which filed a friend-of-the-court brief for Dr. Nelson in the Supreme Court case.


In a 2009 report titled “NASA Needs to Remedy Vulnerabilities in Key Networks,” the Government Accountability Office noted that the agency had reported 1,120 security incidents in fiscal 2007 and 2008 alone.


It also singled out an incident in 2009 in which a NASA center reported the theft of a laptop containing about 3,000 unencrypted files about arms traffic regulations and wind tunnel tests for a supersonic jet.


“NASA had not installed full-disk encryption on its laptops at all three centers,” the report said. “As a result, sensitive data transmitted through the unclassified network or stored on laptop computers were at an increased risk of being compromised.” Other federal agencies have had similar problems. In 2006, for example, the Department of Veteran’s Affairs reported the theft of an employee laptop and hard drive that contained personal details on about 26.5 million veterans. Last year, the G.A.O. cited the Internal Revenue Service for weaknesses in data control that could “jeopardize the confidentiality, integrity, and availability of financial and sensitive taxpayer information.”


Also last year, the Securities and Exchange Commission warned its employees that their confidential financial information, like brokerage transactions, might have been compromised because an agency contractor had granted data access to a subcontractor without the S.E.C.’s authorization.


In a phone interview, Dr. Nelson, the astronomer, said he planned to hold a news conference on Wednesday morning in which he would ask members of Congress to investigate NASA’s data collection practices and the recent data breach.


Robert Jacobs, a NASA spokesman, said the agency’s data security policy already adequately protected employees and contractors because it required computers to be encrypted before employees took them off agency premises. “We are talking about a computer that should not have left the building in the first place,” Mr. Jacobs said. “The data would have been secure had the employee followed policy.”


The government argued in the case Dr. Nelson filed that a law called the Privacy Act, which governs data collection by federal agencies, provided the scientists with sufficient protection. The case reached the Supreme Court, which upheld government background checks for employees of contractors. The roots of Dr. Nelson’s case against NASA date back to 2004 when the Department of Homeland Security, under a directive signed by President George Bush, required federal agencies to adopt uniform identification credentials for all civil servants and contract employees. As part of the ID card standardization process, the department recommended agencies institute background checks.


Several years later, when NASA announced it intended to start doing background checks at the Jet Propulsion Laboratory, Dr. Nelson and other scientists there objected.


Those security checks could have included inquiries into medical treatment, counseling for drug use, or any “adverse” information about employees such as sexual activity, or participation in protests, said Dan Stormer, a lawyer representing Dr. Nelson.


But Dr. Nelson and other long-term employees of the lab challenged the legality of those checks, arguing that they violated their privacy rights. NASA, they said, had not established a legitimate need for such extensive investigations about low-risk employees like themselves who did not have security clearances or handle confidential information. Dr. Nelson, for example, specializes in solar system science — concerning, for example, Jupiter’s moon Io and Titan, a moon of Saturn — and publishes his work in scientific journals


“It was an invitation to an open-ended fishing expedition,” Dr. Nelson said of the background checks.


In friend of the court briefs for Dr. Nelson, privacy groups cited many data security problems at federal agencies, arguing that there was a risk that NASA was not equipped to protect the confidential details it was collecting about employees and contractors.


In 2008, the United States Court of Appeals for the Ninth Circuit in San Francisco temporarily halted the background checks, saying that the case had raised important questions about privacy rights. But last year, the Supreme Court upheld the background investigations of employees of government contractors.


Dr. Nelson said he retired from the Jet Propulsion Laboratory last June rather than submit to a background check. He now works as a senior scientist at the Planetary Science Institute of Tucson.


NASA has contracted with ID Experts, a data breach company, to help protect employees whose data was contained on the stolen laptop against identity theft. Mr. Jacobs, the NASA spokesman, said the agency has encrypted almost 80 percent of its laptops and plans to encrypt the rest by Dec. 21. He added that he too received a letter from NASA warning that his personal information might have been compromised by the laptop theft.


Read More..

Cyber Monday sales up 17% to nearly $2 billion, exceeding forecast









Cyber Monday online sales beat forecasts by nearly half a billion dollars.


ComScore on Monday predicted that Cyber Monday would generate $1.5 billion in online sales, but according to Adobe, the shopping day ended up raking in $1.98 billion, which was a 17% increase compared to last year.


That practically doubled online Black Friday sales, which topped $1 billion this year for the first time, according to ComScore.





And if Cyber Monday's online sales weren't impressive enough, Adobe says that mobile shopping doubled from last year and accounted for 22% of Cyber Monday sales.


On the opposite end of that spectrum was social, which referred only a dismal 2% of total site visits on Cyber Monday. Even worse for Facebook and Twitter is the fact their number of referrals stayed the same as last year's, while Pinterest's referrals for the holiday grew 105%, accounting for 15% of social referrals.


As for what people were buying, Adobe said that toys and sporting goods led the way, followed by health and beauty. Home and auto was the third most selling category.


Adobe said you can follow its tracking of online holiday shopping with this tool, which keeps track of current sales and estimates how the rest of the holiday shopping days will fare.


ALSO:


Internet surfing while driving is on the rise


Apple's new ultra-thin iMac goes on sale Friday


Tumblr now among top 10 U.S. sites with 168 million global users





Read More..