Top medical innovations address headache, diabetes, cancer

























(Reuters) – The best medical innovations for next year include an almond-size device that’s implanted in the mouth to relieve severe headaches and a hand-held scanner resembling a blow dryer that detects skin cancer, the Cleveland Clinic said on Wednesday.


The clinic’s annual list of the best medical innovations for 2013 also includes new drugs to treat advanced prostate cancer and better mammography technology.





















But leading the 2013 list for innovations is an old procedure that has a new use due to findings in a recent study. Physicians and researchers at the clinic voted weight-loss surgery as the top medical innovation, not for its effectiveness in reducing obesity, but for its ability to control Type 2 diabetes, the most common form of the disease.


Over the years, bariatric surgeons noticed that the procedure would often rid obese patients of Type 2 diabetes, before they even left the hospital.


A study, led by Cleveland Clinic head of Bariatric and Metabolic Institute Dr. Philip Schauer, examining this phenomenon was published in the prestigious New England Journal of Medicine earlier this year.


Bariatric surgery has been around for a while. The reason it was chosen as the top innovation is because Medicare has broadened its indication for payment, and Medicaid in many states follows Medicare. A lot of the other (private) insurance companies started covering it, so it’s much more accessible,” Dr. Michael Roizen, the Cleveland Clinic’s Chief Wellness Officer, said in an interview.


The criteria that insurers use to cover the surgery has been broadened because of its effectiveness in controlling Type 2 diabetes, he said.


The number of people affected by diabetes has tripled over the past 30 years to more than 20 million Americans, according to the Centers for Disease Control and Prevention, and more than 90 percent of those cases are Type 2.


Doctors and researchers at the Cleveland Clinic voted for what they thought were the biggest, most significant innovations from the 250 ideas submitted from their colleagues at the clinic. Roizen said one of the main contributing factors to getting on the list is the number of people that the product or procedure can potentially help.


For that reason, a device that helps relieve headaches, the second most common ailment after the cold, was second on the clinic’s list.


The miniaturized device — invented at the Cleveland Clinic and spun off into a separate, private company called Autonomic Technologies Inc — is implanted in the upper gum above the second molar to treat cluster headaches and migraine headaches. A lead tip of the implant is placed near specific nerves behind the bridge of the nose.


When the patient feels the headache coming on, a remote control device is placed on the outside of the cheek and the device delivers stimulation to those nerves, blocking headache pain.


The implant is available in Europe, but not in the United States. The company needs to do more studies to get FDA approval, said Dr. Frank Papay, Department Chair of Dermatology and Plastic Surgery Institute at the Cleveland Clinic, and consultant to Autonomic Technologies.


A hand-held device used to detect melanoma, the most deadly form of skin cancer, was also on the list.


“Up until now, we’ve counted on our eyes,” Dr. Allison Vidimos, Department Chair of Dermatology at the Cleveland Clinic, told Reuters. “This device offers an objective look underneath the skin using a special spectrum of light.”


It compares moles and other things it finds on the patient’s skin with a large database containing information on all types of melanoma. It also rates the risk.


“All dermatologists fear missing melanomas. The cure rate can be close to 100 percent if caught early,” she said.


Vidimos said using the device, approved by FDA last year for use by trained dermatologists, helps prevent unnecessary biopsies.


Mela Sciences Inc make the scanning device.


Also on the list is a new type of mammography, called breast tomosynthesis. This technology provides greater detail of the image than the standard mammography, which renders a 2-dimensional image.


For the patient, it may seem like there’s no difference. “You still have the squish,” said Dr. Alice Rim, Section Head of Diagnostic Radiology. But the images produced by the new technology show the breast in slices, so far more detail can be seen.


“With 2-demensional mammography, there are shadows, so it can be like a polar bear running around in a snow storm. This eliminates the shadows, allowing increased detection and fewer call backs (for a second mammography),” Rim said.


Other devices that made the list include mass spectrometry for bacterial infections, which allow microbiology laboratories to identify the type of bacteria sooner and with more specificity, a new modular stent graft to treat complex aortic aneurysm and a laser used for cataract surgery.


Novel drugs to treat advanced prostate cancer were on the clinic’s list because of their ability to halt the progress of the disease by blocking testosterone receptors.


A new technique to repair and regenerate damaged lungs, called ex vivo lung perfusion, is on the list. Experts say as many as 40 percent of previously rejected donor lungs may now be suitable for transplantation after undergoing this novel “lung washing”.


The procedure involves placing donor lungs into a bubble-like chamber connected to a cardiopulmonary pump and ventilator. Over four to six hours, the lungs are repaired as special fluids are forced through the blood vessels. Nutrients are used to recondition the lungs as they inflate and deflate.


The final item on the list is neither a procedure, a drug nor a device, but healthcare programs that use incentives to encourage people to take better care of themselves.


The Medicare Better Health Rewards Program Act of 2012 provides incentive payments to Medicare participants who voluntarily establish and maintain better health.


“We are seeing efforts to avoid rationing of healthcare and seeing programs with incentives built in if people maintain their health. This can radically change the cost of care,” said Roizen. “We’re seeing this more in big companies, the GE’s and J&J’s of the world. All companies are looking at how much they are spending on healthcare and they are looking at ways they can reduce spending without rationing.”


(Reporting By Debra Sherman; Editing by David Gregorio)


Seniors/Aging News Headlines – Yahoo! News



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Apple's iPad mini packs full-sized punch but screen inferior: reviews

SAN FRANCISCO (Reuters) - Apple Inc's entry in the accelerating mobile tablet race squeezes about 35 percent more viewing space onto a lighter package than rival devices from Google or Amazon.com Inc, but it sports inferior resolution and a lofty price tag, two influential reviewers wrote on Tuesday.


The iPad mini, which starts at $329 versus the $199 for Google's Nexus 7 and Amazon's Kindle Fire HD, is easy to hold with one hand, eliminating a drawback of the 10-inch iPad, Wall Street Journal columnist Walt Mossberg wrote in one of the first major reviews of a gadget introduced last week.


Both Mossberg and New York Times columnist David Pogue offered kudos for cramming most of its full-sized cousin's functions onto a smaller device, as advertised.


But the iPad mini's 1024 x 768 resolution was a big step backwards from the iPad's much-touted Retina display, and underperformed the rival Kindle and Nexus, the two reviewers agreed.


Mossberg said Apple chose to go with a lower-quality display because the existing 250,000-plus iPad applications could only run unmodified in two resolutions - and the higher level would have sapped too much power.


"The lack of true HD gives the Nexus and Fire HD an advantage for video fans. In my tests, video looked just fine, but not as good as on the regular iPad," Mossberg wrote.


The original iPad was launched in 2010 and went on to upend the personal computer industry, spawning a raft of similar devices. The iPad mini marks Apple's first foray into a smaller 7-inch segment that Amazon's Kindle Fire now dominates, demonstrating demand exists for such a device.


Apple, making its boldest consumer hardware move since Tim Cook took the helm from late co-founder Steve Jobs, hopes the smaller tablet can beat back incursions onto its home turf of consumer electronics.


"In shrinking the iconic iPad, Apple has pulled off an impressive feat," Mossberg wrote. "It has managed to create a tablet that's notably thinner and lighter than the leading small competitors with 7-inch screens, while squeezing in a significantly roomier 7.9-inch display.


"And it has shunned the plastic construction used in its smaller rivals to retain the iPad's sturdier aluminum and glass body."


Mossberg, whose reviews are followed closely by consumers and tech companies alike, wrote that the iPad mini did as advertised by bringing the full-sized iPad experience onto a smaller screen.


He noted, however, that the device was too large to fit easily into pockets. It exhibited battery life of about 10 hours and 27 minutes, an hour more than the Kindle Fire at the same settings, but about 17 minutes less than the Nexus 7.


"By pricing the Mini so high, Apple allows the $200 class of seven-inch Android tablets and readers to live," Pogue wrote.


"But the iPad Mini is a far classier, more attractive, thinner machine. It has two cameras instead of one. Its fit and finish are far more refined. And above all, it offers that colossal app catalog, which Android tablet owners can only dream about."


(Reporting By Edwin Chan; Editing by Ken Wills)


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Hurricane’s death toll rises to 65 in Caribbean

























PORT-AU-PRINCE, Haiti (AP) — As Americans braced Sunday for Hurricane Sandy, Haiti was still suffering.


Officials raised the storm-related death toll across the Caribbean to 65, with 51 of those coming in Haiti, which was pelted by three days of constant rains that ended only on Friday.





















As the rains stopped and rivers began to recede, authorities were getting a fuller idea of how much damage Sandy brought on Haiti. Bridges collapsed. Banana crops were ruined. Homes were underwater. Officials said the death toll might still rise.


“This is a disaster of major proportions,” Prime Minister Laurent Lamothe told The Associated Press, adding with a touch of hyperbole, “The whole south is under water.”


The country’s ramshackle housing and denuded hillsides are especially vulnerable to flooding. The bulk of the deaths were in the southern part of the country and the area around Port-au-Prince, the capital, which holds most of the 370,000 Haitians who are still living in flimsy shelters as a result of the devastating 2010 earthquake.


Santos Alexis, mayor of the southern city of Leogane, said Sunday that the rivers were receding and that people were beginning to dry their belongings in the sun.


“Things are back to being a little quiet,” Alexis said by telephone. “We have seen the end.”


Sandy also killed 11 in Cuba, where officials said it destroyed or damaged tens of thousands of houses. Deaths were also reported in Jamaica, the Bahamas and Puerto Rico. Authorities in the Dominican Republic said the storm destroyed several bridges and isolated at least 130 communities while damaging an estimated 3,500 homes.


Jamaica’s emergency management office on Sunday was airlifting supplies to marooned communities in remote areas of four badly impacted parishes.


In the Bahamas, Wolf Seyfert, operations director at local airline Western Air, said the domestic terminal of Grand Bahamas‘ airport received “substantial damage” from Sandy’s battering storm surge and would need to be rebuilt.


Latin America News Headlines – Yahoo! News



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Rolling Stones memorabilia auctioned after divorce

























NEW YORK (Reuters) – An assortment of Rolling Stones memorabilia and artwork provided by Rolling Stones guitarist Ronnie Wood and his ex-wife was sold in a two-day auction, Julien’s Auctions said on Sunday.


The collection featured memorabilia spanning four decades from the guitarist’s work with the band, and included several worn leather and velvet jackets, real and cardboard guitars, tour ephemera and a signed lithograph of Eric Clapton.





















Among the items were a white leather coat worn by Wood that sold for $ 8,960, and a lithograph of Eric Clapton drawn by Wood that features his signature as well as Clapton’s that fetched $ 5,120.


Despite being made of cardboard, a guitar cutout gifted to Wood by Keith Richards sold for $ 6,875. The real thing commanded almost nine times that price, with a 1955 Fender Stratocaster guitar often played on stage by Wood bringing in $ 60,800.


Bidding took place live online as well as in person and by phone at Julien’s Beverly Hills gallery on Friday and Saturday.


The auction comes ahead of the release next February of the memoirs of Wood’s ex-wife Jo, which promise to reveal her tales of life as the wife of a Rolling Stone.


Ronnie and Jo Wood were married for 23 years before separating in 2008 when Ronnie left her for a young cocktail waitress named Ekaterina Ivanova. The couple’s divorce was finalized in 2011.


After the auction was announced in September, the former couple issued opposing statements feuding about the ownership of the auction items, but seemed to have worked out their disagreements. Julien described the items for sale as jointly owned and said that they were part of the couple’s divorce settlement.


Part of the proceeds from the auction will go to MusiCares, the Grammy Awards charity that offers help to people in the music industry with finance and addiction.


Wood has recently been focused on his visual art career, but is best known as a musician with the Rolling Stones and The Faces. He has been inducted into the Rock and Roll Hall of Fame twice.


In addition to her upcoming memoirs, Jo Wood – a former model – has also founded a skincare line.


(Reporting by Andrea Burzynski, editing by Gary Crosse)


Music News Headlines – Yahoo! News



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Meningitis outbreak spreads to 19 states with case in Rhode Island

























(Reuters) – The deadly meningitis outbreak tied to steroid injections from potentially tainted medications spread to a 19th state on Monday with the first case reported in Rhode Island, the Centers for Disease Control and Prevention said.


Only four of the 23 states that received some of the medication have not reported cases of fungal meningitis, which has killed 25 people nationwide.





















The four states that have not reported at least one case of meningitis are California, Nevada, West Virginia and Connecticut, the CDC said.


The total number of meningitis cases including the expansion to Rhode Island reached 347 nationwide on Monday, the CDC said, up 10 from the last report on Saturday.


There also are seven reported cases of infections after the tainted steroid was injected into a joint such as a knee, hip, shoulder or elbow, bringing the total number of infections to 354.


The steroid was supplied by New England Compounding Center of Massachusetts, which faces multiple investigations. Health authorities have said its facility near Boston failed to make medications in sterile conditions.


(Reporting by Greg McCune; Editing by Eric Beech)


Health News Headlines – Yahoo! News



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Sandy: East Coast braces for epic hurricane, ‘life-threatening’ storm surge

Waves crash into a pier in Nags Head, N.C., Oct. 27, 2012. (Gerry Broome/AP)


[UPDATED: 8:00 p.m. ET]


"Superstorm." "The Perfect Storm." "Frankenstorm."


Whatever you want to call it, the East Coast is bracing for Hurricane Sandy, a "rare hybrid storm" that is expected to bring a life-threatening storm surge to the mid-Atlantic coast, Long Island Sound and New York harbor, forecasters say, with winds expected to be at or near hurricane force when it makes landfall sometime on Monday.


According to the National Hurricane Center, the Category 1 hurricane was centered about 280 miles southeast of Cape Hatteras, N.C., and 485 miles south of New York City early Sunday, carrying maximum sustained winds of 75 mph and moving northeast at 15 mph.


[Slideshow: Latest photos from Hurricane Sandy]


New York Mayor Michael Bloomberg ordered the immediate, mandatory evacuation for low-lying coastal areas, including Coney Island, the Rockaways, Brighton Beach, Red Hook and some parts of lower Manhattan along the East River.


"If you don't evacuate, you're not just putting your own life at risk," Mayor Bloomberg said at a news conference Sunday. "You're endangering first responders who may have to rescue you."


New Jersey Governor Chris Christie's message for residents was a bit more blunt. "Don't be stupid," Christie said Sunday afternoon, announcing the suspension of the state's transit system beginning at 12:01 a.m. Monday.


Earlier, New York Governor Andrew Cuomo announced the suspension of all MTA service--including subways, buses, Long Island Railroad and Metro North--beginning at 7 p.m. Sunday. New York City Public Schools will be closed on Monday, the mayor said. The New York Stock Exchange said its trading floor will be closed on Monday, too--the first such shutdown in 27 years, according to the Wall Street Journal.


[Related: Superstorm could impact 60 million]


Sandy is expected to continue on a parallel path along the mid-Atlantic coast later Sunday before making a sharp turn toward the northwest and southern New Jersey coastline on Monday--with the Jersey Shore and New York City in its projected path.


But the path is not necessarily the problem.


"Don't get fixated on a particular track," the Associated Press said. "Wherever it hits, the rare behemoth storm inexorably gathering in the eastern U.S. will afflict a third of the country with sheets of rain, high winds and heavy snow."


(FEMA)


A tropical storm warning has been issued between Cape Fear to Duck, N.C., while hurricane watches and high-wind warnings are in effect from the Virginia to Massachusetts. The hurricane-force winds extend 175 miles from the epicenter of the storm, while tropical storm-force winds extend 500 miles--or roughly 1,000 miles end to end, making Sandy one of the biggest storms to ever hit the East Coast.


"We're looking at impact of greater than 50 to 60 million people," Louis Uccellini, head of environmental prediction for the National Oceanic and Atmospheric Administration, told the Associated Press.


"The size of this alone, affecting a heavily populated area, is going to be history making," Jeff Masters wrote on the Weather Underground blog.


President Barack Obama received a briefing on the storm at Federal Emergency Management Agency headquarters in Washington on Sunday. "My main message to everybody involved is that we have to take this seriously," President Obama said. "[We will] respond big and respond fast."


[Also read: Big storm scrambles presidential race schedules]


"I can be as cynical as anyone," Christie said on Saturday, announcing a state of emergency. "But when the storm comes, if it's as bad as they're predicting, you're going to wish you weren't as cynical as you otherwise might have been."


Meanwhile, emergency evacuations were being mulled by state officials in Connecticut, Massachusetts, Vermont, New Hampshire and even Maine.


In Virginia, Governor Bob McDonnell said 20,000 homes there had already reported power outages.


(Weather.com)


"This is not a coastal threat alone," said FEMA director Craig Fugate said during a media briefing early Sunday. "This is a very large area."


Forecasters also fear the combination of storm surge, high tide and heavy rain--between 3 and 12 inches in some areas--could be life-threatening for coastal residents.


According to the National Hurricane Center summary, coastal water levels could rise anywhere between 1 and 12 feet from North Carolina to Cape Cod, depending on the timing of the "peak surge." A surge of 6 to 11 feet is forecast for Long Island Sound and Raritan Bay, including New York Harbor.


The storm surge in New York Harbor during Hurricane Irene in September 2011, forecasters noted, was four feet.


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“Argo” rises above “Cloud Atlas” as Sandy spooks

























LOS ANGELES (Reuters) – Acclaimed Iran hostage thriller “Argo” brought home its first box-office win over a quiet weekend, leading movie charts with $ 12.4 million in U.S. and Canadian ticket sales as would-be moviegoers hunkered down for Hurricane Sandy.


The tally for “Argo,” directed by and starring Ben Affleck, topped the $ 9.4 million for new sci-fi drama “Cloud Atlas“. Halloween-themed animated film “Hotel Transylvania” scared up $ 9.5 million from Friday through Sunday, narrowly edging “Cloud Atlas“, studio estimates showed.





















After two weeks in the No. 2 spot, “Argo” moved into the lead and lifted its domestic sales to $ 60.8 million through three weekends.


The movie, produced by Warner Bros. and GK Films for $ 44 million, tells the story of a mission to rescue U.S. government employees from Iran in 1979. The film has earned Oscar buzz after stellar reviews from critics and an “A+” grade from audiences polled by CinemaScore.


Dan Fellman, president of theatrical distribution for Warner Bros., a unit of Time Warner Inc, attributed the film’s jump to “great word-of-mouth”, which he called “the best form of advertising”.


Cloud Atlas“, also from Warner Bros., fell short of industry forecasts for a $ 13 million debut at North American (U.S. and Canadian) theaters. Fellman said the film did better in larger cities, but struggled in the South and Midwest.


The film, starring Tom Hanks and Halle Berry, cost $ 100 million to make. Many in Hollywood thought the story, based on a philosophical novel by David Mitchell, was too complex to bring to the big screen.


The nearly three-hour film with six interweaving stories divided critics, with the harshest reviewers saying it would try audiences’ patience with multiple storylines and century-hopping plots. The film’s stars also shift characters. Hanks, for example, is a shady doctor in the 1840s, a nuclear scientist in the 1970s and a simple valley-dweller in the distant future.


But “Cloud Atlas” also drew praise as an ambitious and well-acted epic. Sixty-one percent of reviews on the Rotten Tomatoes website recommended the film.


Hotel Transylvania” set a record for a September film opening in North America when it opened on September 28, and has performed solidly since then.


In the family comedy, Frankenstein, the Invisible Man and other monsters gather for a party at a high-end resort operated by Dracula. Their celebration is disrupted when a boy discovers the hotel and falls in love with Dracula’s daughter but must deal with her overprotective father.


The president of worldwide distribution for Sony Corp‘s Sony Pictures studio, Rory Bruer, wasn’t entirely surprised that the weeks-old movie beat “Cloud Atlas“, despite the latter movie’s buzz.


“Anything at this point doesn’t surprise me,” Bruer said. “It’s like an annuity that keeps on giving and giving.”


Paul Dergarabedian, box office analyst at Hollywood.com, said the Halloween weekend gave the film a boost, and is “still the number one choice for families” among the spooky seasonal films currently playing.


This weekend was fairly quiet at the box office in North America, which Dergarabedian attributed to Hurricane Sandy, a storm menacing the East Coast of the United States.


However, the new James Bond movie “Skyfall” whipped up a storm of its own overseas, taking $ 77.7 million in 25 countries. The latest installment of the British spy saga took the top spot in all 25 countries, broke the all-time Saturday attendance record in the United Kingdom, and was the biggest film opening there of 2012. It will open in the United States on November 9.


Rounding out the weekend’s top five, low-budget horror sequel “Paranormal Activity 4″ grossed $ 8.7 million at domestic theaters. “Silent Hill: Revelation 3D” and “Taken 2″ tied for fifth place, each pulling in $ 8 million.


Two other new films failed to crack the top five.


New Halloween-themed comedy “Fun Size” brought in $ 4.1 million at domestic theaters, landing in tenth place. The $ 14 million production tells the story of a boy who goes missing among trick-or-treaters, sparking his teen sister’s frantic search to find him before her mother comes home.


Sports drama “Chasing Mavericks” disappointed, failing to break the top ten. The movie stars Gerard Butler in the story of a surfer who tries to conquer one of the biggest waves on Earth.


Silent Hill: Revelation 3D” was released by Open Road Films, a joint venture between theater owners Regal Entertainment Group and AMC Entertainment Inc. Paramount Pictures, a unit of Viacom Inc, released “Fun Size” and “Paranormal Activity 4″.


“Chasing Mavericks” was distributed by News Corp’s 20th Century Fox studio. Sony Corp’s movie division released “Hotel Transylvania“.


(Reporting by Lisa Richwine and Andrea Burzynski; Editing by Will Dunham and Dale Hudson)


Movies News Headlines – Yahoo! News



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U.S. regulator needs new authority over compounding pharmacies: report

























WASHINGTON (Reuters) – The U.S. Food and Drug Administration‘s power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.


The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner “the authority we need to help prevent tragedies like this from happening again.”





















“Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry,” Hamburg said in a statement emailed to Reuters.


“As pointed out in the report from Congressman Markey, FDA’s authority over compounding pharmacies is more limited by statute than with drug manufacturers,” she added.


The Markey report and Hamburg’s comments surfaced as Congress has begun preliminary discussions that could give the FDA new powers to oversee compounding pharmacies like the New England Compounding Center, which is at the heart of a fungal meningitis outbreak that has sickened 337 people, including 25 who have died, in 18 states.


But the public health crisis has also stirred debate about how much authority the FDA actually needs. Last week, the advocacy group Public Citizen called on the Department of Health and Human Services to investigate the agency on grounds that it failed to exercise its existing authority to prevent the meningitis outbreak.


The FDA issued a warning letter to NECC in 2006 describing potential health risks including microbial contamination. But there has been little evidence of a follow-up. Congressional investigators also say there is evidence that the FDA and state regulators knew of potential problems at NECC in 2002.


Hamburg has had little to say publicly about the regulatory issue. “FDA’s primary focus right now is containing the immediate crisis, protecting patients and their families from any further harm and completing our investigation,” she said.


Compounding is a traditional pharmacy practice in which a pharmacist alters, mixes or recombines ingredients to make a drug that meets the special needs of a patient with a physician’s prescription. But in recent decades, officials say some compounding operations have grown to resemble full-scale manufacturing without meeting FDA standards.


DOZENS OF WARNING LETTERS


The congressman’s report, based partly on documents gathered by investigators in the House of Representatives, says state governments that are now the chief regulators of pharmacy compounding cannot perform the kind of safety oversight necessary to prevent more drug-related outbreaks from occurring.


The FDA has issued dozens of warning letters against compounding pharmacies since 2001. But the report said the agency has based its enforcement actions on relatively weak, nonbinding guidance documents since a 1997 law granting it oversight of “new drugs” was struck down in U.S. courts more than a decade ago in cases brought by compounders.


“Guidance documents do not establish legally enforceable rights or responsibilities and do not legally bind the public or the FDA,” said a Congressional Research Services report cited by Markey’s staff.


That gives the agency far less power over compounding operations than it has over conventional drug manufacturers, which must submit to stringent safety and efficacy standards.


“Absent clear new authority, FDA’s efforts will ultimately be constrained by gaps in regulatory authority and thwarted by an industry that has historically resisted a federal role for the oversight of its activities,” said Markey.


An aide to Markey, who is on the House Energy and Commerce Committee which is conducting one of two congressional investigations into the outbreak, said the report was compiled from staff research. The aide acknowledged that some of the documents also form part of the House panel’s probe.


Markey has said he will propose legislation to enhance FDA oversight when Congress returns after the November 6 election. The committee is expected to hold hearings by the end of the year.


The report cites FDA documents as saying that compounded drugs may have been responsible for at least 23 deaths and 86 other cases of disease or injury before the current outbreak, related to injectable steroid treatments for back and joint pain first drew public attention last month.


FDA records described by the report also show that 10 of 29 compounded products tested by the FDA in 2003 failed at least one of the regulatory agency’s safety or efficacy tests. Three years later, in 2006, one-third of 36 compounded drug samples failed FDA analytical testing.


“The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years, and the devastating tragedies of this outbreak will be felt well beyond it,” Markey said.


(Editing by Christopher Wilson)


Medications/Drugs News Headlines – Yahoo! News



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SAP eyes "long" period of high sales growth: report

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Ukraine’s opposition doing well in election

























KIEV, Ukraine (AP) —


Ukraine’s opposition parties performed strongly in Sunday’s parliamentary vote, according to an exit poll, but President Viktor Yanukovych‘s party could still retain control of the legislature as its members are likely to sweep individual races across the country.





















The West is paying close attention to the conduct of the vote in the strategic ex-Soviet state, which lies between Russia and the European Union, and serves as a key conduit for transit of Russian energy supplies to many EU countries. An election deemed unfair would likely turn Ukraine further away from the West and toward Moscow.


Opposition parties alleged widespread violations on election day, such as vote-buying and a suspiciously high amount of home voting, but a local election monitor said those violations were isolated. Authorities insisted the election was honest and democratic.


The Fatherland party, led by the jailed charismatic former Prime Minister Yulia Tymoshenko, the Udar (Punch) of world boxing champion Vitali Klitschko and a nationalist party together received more than 50 percent of the vote on party lists, outnumbering Yanukovych’s Party of Regions and its traditional ally, the Communist Party.


Both Yanukovych’s and Tymoshenko’s parties claimed victory, saying the election showed the voters trust them to lead the country.


However, only half of the parliament’s 450 seats are split proportionately between the winning parties. The other half is filled by the winners of single-mandate races, where Yanukovych loyalists are expected to make a strong showing. In the election, each voter had two ballots, one with party names and one with the name of candidates in specific constituencies. No exit poll numbers were available for the individual races.


With Yanukovych under fire over the jailing of his top rival, Tymoshenko; rampant corruption and slow reforms, the opposition made a strong showing.


Tymoshenko’s Fatherland party is poised to get about 25 percent of the proportional vote, the Udar (Punch) led by world boxing champion Vitali Klitschko is set to get around 15 percent and the nationalist Svoboda (Freedom) party receives some 12 percent. The Party of Regions polled 28 percent and the Communists nearly 12 percent.


If the three opposition groups unite, they could get 127 parliament seats versus 98 seats gained by the Regions and Communists. The distribution of the remaining 225 seats is expected to be clear Monday.


Opposition forces hope to garner enough parliament seats to weaken Yanukovych’s power and undo the damage they say he has done: the jailing of Tymoshenko and her top allies, the concentration of power in the hands of the president, the snubbing of the Ukrainian language in favor of Russian, waning media freedoms, a deteriorating business climate and growing corruption.


The strong showing by the far-right Svoboda (Freedom) party which campaigns for the defense of the Ukrainian language and culture but is also infamous for xenophobic and anti-Semitic rhetoric emerged as a surprise and showed the widespread disappointment and anger with the ruling party.


It remains to be seen whether Tymoshenko’s group, Klitschko’s party and Svoboda can forge a strong alliance and challenge Yanukovych.


The election tainted by Tymoshenko’s jailing on charges of abuse of office has also been compromised by the creation of fake opposition parties, campaigns by politically unskilled celebrities, and the use of state resources and greater access to television by Yanukovych’s party.


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Yuras Karmanau in Kiev contributed to this report.


Europe News Headlines – Yahoo! News



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