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রবিবার, ২৩ জুন, ২০১৩
Doctors make progress toward 'artificial pancreas'
This October 2012 image provided by Medtronic shows the MiniMed Integrated System device, which doctors are reporting as a major step toward an "artificial pancreas." The device that would constantly monitor blood sugar in people with diabetes and automatically supply insulin as needed. According to the company-sponsored study announced Saturday, June 22, 2013 at an American Diabetes Association conference in Chicago the device worked as intended in a three-month study of 247 patients. (AP Photo/Medtronic)
This October 2012 image provided by Medtronic shows the MiniMed Integrated System device, which doctors are reporting as a major step toward an "artificial pancreas." The device that would constantly monitor blood sugar in people with diabetes and automatically supply insulin as needed. According to the company-sponsored study announced Saturday, June 22, 2013 at an American Diabetes Association conference in Chicago the device worked as intended in a three-month study of 247 patients. (AP Photo/Medtronic)
Doctors are reporting a major step toward an "artificial pancreas," a device that would constantly monitor blood sugar in people with diabetes and automatically supply insulin as needed.
A key component of such a system ? an insulin pump programmed to shut down if blood-sugar dips too low while people are sleeping ? worked as intended in a three-month study of 247 patients.
This "smart pump," made by Minneapolis-based Medtronic Inc., is already sold in Europe, and the U.S. Food and Drug Administration is reviewing it now. Whether it also can be programmed to mimic a real pancreas and constantly adjust insulin based on continuous readings from a blood-sugar monitor requires more testing, but doctors say the new study suggests that's a realistic goal.
"This is the first step in the development of the artificial pancreas," said Dr. Richard Bergenstal, diabetes chief at Park Nicollet, a large clinic in St. Louis Park, Minn. "Before we said it's a dream. We have the first part of it now and I really think it will be developed."
He led the company-sponsored study and gave results Saturday at an American Diabetes Association conference in Chicago. They also were published online by the New England Journal of Medicine.
The study involved people with Type 1 diabetes, the kind usually diagnosed during childhood. About 5 percent of the 26 million Americans with diabetes have this type. Their bodies don't make insulin, a hormone needed to turn food into energy. That causes high blood-sugar levels and raises the risk for heart disease and many other health problems.
Some people with the more common Type 2 diabetes, the kind linked to obesity, also need insulin and might also benefit from a device like an artificial pancreas. For now, though, it's aimed at people with Type 1 diabetes who must inject insulin several times a day or get it through a pump with a narrow tube that goes under the skin. The pump is about the size of a cellphone and can be worn on a belt or kept in a pocket.
The pumps give a steady amount of insulin, and patients must monitor their sugar levels and give themselves more insulin at meals or whenever needed to keep blood sugar from getting too high.
A big danger is having too much insulin in the body overnight, when blood-sugar levels naturally fall. People can go into comas, suffer seizures and even die. Parents of children with diabetes often worry so much about this that they sneak into their bedrooms at night to check their child's blood-sugar monitor.
In the study, all patients had sensors that continuously monitored their blood sugar. Half of them had ordinary insulin pumps and the others had pumps programmed to stop supplying insulin for two hours when blood-sugar fell to a certain threshold.
Over three months, low-sugar episodes were reduced by about one-third in people using the pump with the shut-off feature. Importantly, these people had no cases of severely low blood sugar ? the most dangerous kind that require medical aid or help from another person. There were four cases in the group using the standard pump.
"As a first step, I think we should all be very excited that it works," an independent expert, Dr. Irl Hirsch of the University of Washington in Seattle, said of the programmable pump.
The next step is to test having it turn off sooner, before sugar falls so much, and to have it automatically supply insulin to prevent high blood sugar, too.
Dr. Anne Peters, a diabetes specialist at the University of Southern California, said the study "represents a major step forward" for an artificial pancreas.
One participant, Spears Mallis, 34, a manager for a cancer center in Gainesville, Ga., wishes these devices were available now. He typically gets low-sugar about 8 to 10 times a week, at least once a week while he's asleep.
"I would set an alarm in the middle of the night just to be sure I was OK. That will cause you to not get a good night of rest," he said.
His "smart pump" stopped giving insulin several times during the study when his sugar fell low, and he wasn't always aware of it. That's a well-known problem for people with Type 1 diabetes ? over time, "you become less and less sensitive to feeling the low blood sugars" and don't recognize symptoms in time to drink juice or do something else to raise sugar a bit, he said.
Besides Medtronic, Johnson & Johnson and several other research groups are working on artificial pancreas devices.
___
Online:
Diabetes info: http://diabetes.niddk.nih.gov/
___
Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP
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শনিবার, ২২ জুন, ২০১৩
Stanford Center for Sleep Sciences and Medicine: Stanford's Research Provides Hope for Patients With Narcolepsy
Julie Flygare and Dr. Emmanuel Mignot at the SLEEP 2013 meeting in Baltimore.
On a recent trip to San Francisco, I boarded a train headed south to Palo Alto to visit the Stanford Center for Narcolepsy. As the train whizzed through the Bay Area, I reflected on my long and unexpected journey to arrive at this point.
In 2005, I awoke one night to a burglar breaking into my apartment. I'd recently graduated from Brown University and moved into my first "grown up" apartment with a friend in Boston. On this evening, a man in a dark brown hoodie approached me with his arms stretched out toward my neck. I squirmed to get away, but couldn't move. My body was unresponsive, as if wearing a straitjacket.
A few minutes later, I could move again and sat up abruptly, my heart racing with adrenaline pumping. Where was the intruder now? The apartment was silent and all the windows and doors were securely locked. I went back to sleep, confused.
Later that year, I was laughing with a friend about a joke when my knees buckled slightly, as if someone had poked behind my knees. The weakness felt dramatic inside but passed quickly before I was sure what had happened.
This strange momentary weakness began happening every few weeks and started affecting my arms and neck as well. More emotions brought it on -- like annoyance, sexual pleasure, and surprise.
In the fall of 2006, I entered law school, excited for the academic challenges ahead. Before long, I was struggling more than I'd imagined, unable to stay awake in class and while studying at night. Where was my strong willpower?
One morning toward the end of my first year of law school, I awoke in my school's parking lot, unable to recall arriving there. I'd driven just 15 minutes in the morning after getting nine hours to sleep.
"Maybe I have a sleep problem," I said to myself for the first time.
By this time, burglars and other realistic night visitors invaded my sleep regularly. My body continued collapsing with emotions and had gotten worse. Now, I was falling to the ground for a minute or two, paralyzed and unable to speak or move, but remaining conscious and aware of my surroundings.
After multiple primary care doctors missed my diagnosis, I randomly mentioned my knee-buckling laughter to a sports medicine therapist who thought she'd heard of something like that called "cataplexy." At home, I Googled "cataplexy" and discovered it was defined as sudden muscle weakness often triggered by emotion. This described my knee-buckling laughter precisely.
I learned that cataplexy was a symptom of narcolepsy. Other symptoms included excessive daytime sleepiness, hypnagogic hallucinations, and sleep paralysis. Excessive daytime sleepiness offered a possible explanation for my difficulties staying awake. My realistic nighttime burglar experiences sounded a lot like hypnagogic hallucinations and sleep paralysis.
Soon thereafter, I visited a narcolepsy specialist and in September of 2007, at the age of 24, I was officially diagnosed with "narcolepsy with cataplexy," a neurological sleep disorder affecting one in 2,000 Americans and 3 million people worldwide, according to the Narcolepsy Network.
Adjusting to narcolepsy in law school wasn't easy. The treatments improved my symptoms but did not erase them. The medications' side effects left me nauseated and sick in other ways. A few months after the diagnosis, I reached an all-time low, realizing narcolepsy was a serious illness I would face every day of my life. There was no cure.
A half year later, I sat in the silent law school library reading a New York Times article about a researcher named Dr. Emmanuel Mignot, Director of Stanford University's Center for Narcolepsy. Dr. Mignot was unraveling the mysteries of narcolepsy and the possible autoimmune pathology.
The article described: "Dr. Mignot is optimistic about cracking the immune-system connection in narcolepsy soon. 'I don't care actually even if it's going to take a long time,' he said. 'I'm ready to cross deserts.'"
In the article, another doctor states that Dr. Mignot was ideally suited for this work, describing, "This is what is good about Mignot. He is relentless."
Goosebumps raised on my arms as I read this description of Dr. Mignot, a relentless researcher crossing deserts for narcolepsy. That day in the library, I vowed to do my part to help Dr. Mignot build a brighter future for narcolepsy. Although not a scientist, I was determined to make a contribution.
After graduating from law school, I moved to Washington, D.C. to write a memoir and advocate for narcolepsy research on Capitol Hill. I also ran the Boston Marathon in 2010 to raise funds for Dr. Mignot's research.
A few years later, while visiting San Francisco, I made the journey to Palo Alto to finally meet the man behind the magic, the Wizard of Narcolepsy.
Arriving at the Center for Narcolepsy's lab, I gave blood for research purposes and met various researchers exploring the mysteries of sleep and narcolepsy. The scientists patiently translated their work to me. Although some terms went over my head, coming together was joyful, a celebration of our mutual passion for the future of sleep and narcolepsy research.
Last but not least, I had the honor of meeting Dr. Mignot in person. He enthusiastically described his research priorities for the coming years.
"I have some crazy ideas too," he said with a smile and sparkle in his eye.
I couldn't help but chuckle. Dr. Mignot having "some crazy ideas" was great news.
As a person with narcolepsy, I face adversity daily. On hard days, I take solace in knowing that the Wizard of Narcolepsy and his fellow researchers at Stanford are working tirelessly and making progress. Their science is our hope.
Julie Flygare, JD is a leading narcolepsy spokesperson and author of Wide Awake and Dreaming: A Memoir of Narcolepsy. She writes the popular REM Runner blog, organizes the National Sleep Walk, and serves on NIH's Sleep Disorder Research Advisory Board. She is also a patient of the Stanford Center for Sleep Sciences and Medicine. This Center is the birthplace of sleep medicine and includes research, clinical, and educational programs that have advanced the field and improved patient care for decades. To learn more, visit us at: http://sleep.stanford.edu/.
Sources:
Narcolepsy Network. Accessed: June 17, 2013.
Narcolepsy Fact Sheet. National Institute of Neurological Disorders and Stroke. Accessed: June 17, 2013.
For more from the Stanford Center for Sleep Sciences and Medicine, click here.
For more on sleep, click here.
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Conservatives conference highlights murky tax laws
WASHINGTON (AP) ? It was called the "Road to Majority" conference, a not-so-subtle reference to winning control of Capitol Hill in the 2014 midterm elections. Some of the biggest names in the Republican Party ? several potential presidential candidates among them ? offered plans to strengthen the GOP. Breakout sessions included tips on "winning the hearts and minds of young people" and harnessing new technology to win elections.
The political overtones of last week's Faith and Freedom Coalition conference were striking. But organizers insist the event was not focused on politics and say they're not violating laws that prevent tax-exempt groups like theirs, classified as "social welfare" organizations under the tax code, from engaging in direct or indirect political campaigning.
As Congress probes the Internal Revenue Service's targeting of conservative groups, last week's conference at a downtown Washington hotel provided an example of the murky rules and lax enforcement surrounding the expanding network of big-budget nonprofit groups actively working to influence politics and policy.
Such organizations fueled an unprecedented expansion of spending in American politics last fall, using their tax status to hide donors' identities and avoid donation limits while investing more than a quarter of a billion dollars in television advertising, mailings and ground support to help influence elections nationwide.
They're gearing up to play even bigger roles in next year's midterm elections, with huge implications for the balance of power in Congress and President Barack Obama's second-term agenda. Their chief overseer, the IRS, is distracted by a criminal investigation after acknowledging that some of its officials inappropriately scrutinized conservative organizations.
"It's Christmas in June" for nonprofit groups looking to abuse the tax code for political gain, says Marcus Owens, a former director of the IRS' tax-exempt unit. He says the tax enforcement agency is virtually paralyzed while the probe is going on. That leaves the most powerful groups, like the Faith and Freedom Coalition, with little guidance on how to balance political activity, and little disincentive to bend or break the rules.
Owens said the Faith and Freedom Coalition likely "has a tax problem" but organizers "have nothing to fear from the IRS" because it's bogged down by congressional and Justice Department investigations.
The Georgia-based Faith and Freedom Coalition, focused largely on promoting Christian values, is among a growing class of politically active groups ? largely on the conservative side ? operating in a campaign finance system given free rein by a 2010 Supreme Court ruling that opened the floodgates for political money. But politically active nonprofits have been pushing the limits of tax laws for years.
Evangelical leader Ralph Reed founded the Faith and Freedom Coalition in 2009, building on experience as the director of another nonprofit group, the Christian Coalition. The IRS denied that organization's tax-exempt status in 1998, concluding that some of its activities were too partisan. That ruling helped contribute to the once-powerful group's fall from prominence.
Faith and Freedom executive director Gary Marx says his group did not have problems obtaining tax-exempt status in 2009, although some of its smaller state-based affiliates appear to have been caught in the IRS' special focus on conservative groups.
That's in line what organizations across the country call a pattern at the IRS: scrutiny for smaller conservative groups, often delaying their tax-exempt applications for more than a year, but a hands-off policy with the larger, most influential organizations.
The Faith and Freedom Coalition is among those large groups, with reported revenues of $5.5 million in 2010 and $3.4 million in 2011, the most recent tax filing publicly available. In that document, the organization describes its mission as being "committed to educating and informing people at the grassroots level about timely public policy issues and encourage them to participate in the legislative process."
Reed, chairman of the Faith and Freedom Coalition, portrayed a sharply more political mission in the conference program.
"We are building a permanent pro-family, conservative majority, not just in both house of Congress, but in every state house, school board, and city council across the country," he wrote in a message to participants. "The 'Road to Majority' conference is an essential training and equipping weekend to help you stop the radical Obama agenda, advance conservative legislation, and prepare for the 2013-2014 elections."
Asked about the conference's apparent political focus, Marx said there was a "clear public policy" component to the conference, particularly its "lobby day," in which participants traveled to Capitol Hill to discuss immigration, health care and even the regulation of nonprofits with elected officials.
Further, Marx said there was "a deep public policy focus" in the speeches from coalition leaders and invited guests.
Prominent speakers such as Florida Sen. Marco Rubio called on the Republican Party to embrace its opposition to abortion, insisting that "every human life has value ... whether they are born or not." In addition to repeatedly criticizing Obama, former Alaska Gov. Sarah Palin rejected calls for an immigration overhaul that includes a path to citizenship for immigrants in the country illegally. And Republican National Committee Chairman Reince Priebus urged religious conservatives to support the GOP's plans to expand the party's appeal among minorities and younger voters.
Experts on tax-exempt organizations say the Faith and Freedom Coalition waded too deeply into politics for a group registered as a "social welfare" organization under section 501(c)(4) of the federal tax code. That section grants tax-exempt status as long as the primary mission of these organizations is not politics and influencing elections.
"They're simply another example of the problem," said Frances Hill, a University of Miami law professor who is an expert in this area and testified during congressional investigations. "For years, very openly, the IRS has done nothing about a whole range of organizations that don't seem much different from this one ? openly and flamboyantly political in an election campaign sense."
And there is little sign that a divided Congress or an embattled IRS will step up enforcement efforts or clarify guidelines while facing intense public scrutiny. Still, Marx suggested that groups like his need more clarity.
"We want there to be a bright line so there is not this murky gray area," he said.
___
Follow Steve Peoples on Twitter: http://twitter.com/sppeoples
Source: http://news.yahoo.com/conservatives-conference-highlights-murky-tax-laws-072445980.html
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শুক্রবার, ২১ জুন, ২০১৩
U.S. contractor that vetted Snowden is under investigation
By Matt Haldane and Mark Hosenball
WASHINGTON (Reuters) - A U.S. government watchdog is examining a contractor that conducted a 2011 background investigation into Edward Snowden, the source of recent leaks about U.S. secret surveillance programs.
Patrick McFarland, the inspector general for the U.S. Office of Personnel Management, told lawmakers on Thursday that his office is probing USIS, a Falls Church, Virginia-based company that is the largest private provider of federal government background checks.
The USIS investigation predates the Snowden scandal, but McFarland told the homeland security subcommittee hearing that there are now concerns that USIS may not have carried out its background check into Snowden in an appropriate or thorough manner.
The hearing helped underscore questions lawmakers have about the widespread use of contractors in sensitive intelligence work and the oversight of those employees.
Not only is much intelligence work handled by contractors, but private contractors also conduct roughly 75 percent of federal government background checks, according to lawmakers.
Snowden, who disclosed details of the U.S. government's vast phone and Internet surveillance, was a contractor formerly employed by Booz Allen Hamilton who worked at a National Security Agency facility in Hawaii.
USIS conducts federal employee background checks for the Office of Personnel management, the government agency primarily responsible for overseeing such investigations.
"Yes, we do believe that there - there may be some problems," McFarland said of Snowden review.
Senator Rob Portman said the government has a history of flaws in how it deals with security clearances, and said it is particularly critical to properly vet contractors. "Done poorly it can be incredibly damaging," said the Republican from Ohio.
Senator Claire McCaskill described the probe into USIS as a criminal investigation into allegations the company systemically failed to adequately conduct investigations under its contract.
But USIS said in a statement that it has never been informed that it is under "criminal investigation". It said it received a subpoena for records from McFarland's office in January 2012.
"USIS complied with that subpoena and has cooperated fully with the government's civil investigative efforts," the statement said. Regarding Snowden, USIS said it does not comment on confidential background investigations.
SECURITY CONSEQUENCES
Snowden, who is believed to be hiding in Hong Kong, went public in a video released by Britain's Guardian newspaper on June 9 as the source of documents about the U.S. government's surveillance programs.
An Icelandic businessman said on Thursday he has readied a private plane to take Snowden to Iceland if the government grants him asylum.
Snowden had a Top Secret/Sensitive Compartmented Information level clearance.
Senators at the hearing on Thursday said they were concerned about whether people receiving top secret clearances are being properly vetted.
"It is a reminder that background investigations can have real consequences for our national security," McCaskill said of Snowden's leaks. McCaskill, a Democrat from Missouri, chairs the contracting oversight subcommittee of the Senate's Homeland Security Committee.
McCaskill said she was worried that there appears to be a pattern of falsified background checks. She pointed to how at least 18 investigators handling the checks have been convicted of falsifying investigations since 2007.
Senators also raised concerns about a 2009 watchdog investigation that found about 87 percent of OPM investigative reports used to make clearance decisions had incomplete documentation.
Merton Miller, an official in OPM's Federal Investigative Services unit, said the high number was the result of employers not cooperating or subjects being deployed to hostile areas where investigators could not conduct interviews.
He acknowledged his agency needs clearer quality standards. "Quality is in the eye of the beholder," Miller said.
Separately, Senator Bill Nelson on Thursday called for a Senate Intelligence Committee investigation into how contractors are handling employees with top secret clearance.
The Democrat from Florida is concerned there is a pattern of disturbing incidents. He pointed to a previous scandal in which Booz Allen Hamilton had hired an employee convicted of lying to the U.S. government for a position in which he would handle classified documents.
Senate Intelligence Chair Dianne Feinstein has already called for legislation that would limit contractors' access to highly classified information.
OUTSOURCING
McCaskill said USIS also has a contract to support the OPM by managing and overseeing background investigations, an arrangement she said appears to put USIS in a position of oversight of its own work. She added that the company received $200 million last year from OPM.
Security investigations for federal employees used to be conducted mainly by a large staff of full-time investigators who were civil servants at the OPM.
In 1996, the investigative functions of OPM were privatized and the resulting company, USIS, was awarded a contract with OPM to conduct background investigations for security clearances on employees of more than 95 federal agencies.
On its website, USIS says it presently has 100 federal contracts.
USIS is owned by a larger investigative company called Altegrity, which in turn is principally owned by private equity firm Providence Equity Partners.
(Reporting by Matt Haldane and Mark Hosenball; Writing by Karey Van Hall; Editing by Tim Dobbyn)
Source: http://news.yahoo.com/u-contractor-vetted-snowden-under-investigation-002629356.html
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