Football Players Visit Children at Summer Camp

6/22/2012 by Matt Dunaway

BATON ROUGE - LSU football players Dexter Alexander, Allen Buniger and Cleveland Davis spent part of their Thursday visiting children at the Guardian Angels Day Care Summer Camp.

The three players spoke about the challenges of being a student-athlete at LSU and working hard to achieve your goals. Each player stressed the importance of working hard in school and following directions of others.

The campers were decked out in their purple and gold to welcome the football players to their LSU themed play room. The group got to ask each student-athlete questions, throw the football around with the guys and take pictures.

"I visited the summer camp today because I love meeting with young kids," Buniger said. "It's important for them to hear this message at an early age because they can really make a difference as they grow up in this community. I loved seeing them smile when we walked in the room, and it was nice to be able to interact with them today."

The LSU football team embarks on the 2012 season versus North Texas on September 1 at Tiger Stadium.

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Sony - BRAVIA 40" Class / 1080p / 60Hz / LCD - 5 days and 23 hours and 55 minutes

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FDA probes safety issues with metal hip implants

WASHINGTON (AP) ? Metal hip replacements implanted in a half-million Americans may be failing earlier than expected, but it could be years before U.S. health regulators have a clear picture of the problem.

The Food and Drug Administration holds a two-day meeting starting Wednesday to scrutinize the safety of metal-on-metal hip implants, following years of patient reports of pain and swelling that sometimes requires removal of the devices. It is a challenging, but familiar, predicament for the FDA: reviewing the safety of a device that was expected to be superior, but which may actually be more dangerous than what came before.

For decades nearly all orthopedic implants were made from plastic or ceramic. But in the last 10 years some surgeons began to favor implants made with metal stems and sockets. Laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered by surgeons in the U.K. appears to show just the opposite.

In March, British experts at the world's largest artificial joint registry told doctors to stop using metal-on-metal hip replacements, citing an analysis showing they have to be replaced more often than other implants. Hip replacements are supposed to last between 10 to 15 years, but more than 6 percent of patients with metal hips needed them replaced after less than five years. That compared with just 2 percent of people who had ceramic or plastic joints. Both types of devices are prescribed for people suffering hip pain and limited movement due to arthritis or injury.

British regulators now recommend that people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies as the components rub against each other.

The FDA has not made any recommendations of its own for the estimated 500,000 American patients with the devices.

FDA scientists say they want to consider all available information before making their recommendations ? not just the data from the U.K.

"Why look at a single registry when there's data from around the world?" said Dr. William Maisel, FDA's chief scientist for medical devices, in an interview with the Associated Press. "This is an opportunity for us to look at all the available information so that we can have a thoughtful conversation about what clinical recommendations can be made."

Maisel said the FDA is working to combine data from foreign countries and the U.S. to determine which groups of patients and implants are most problematic. On Wednesday and Thursday the FDA will ask a panel of experts to recommend the best practices for monitoring patients with the devices. Panelists will consider blood tests, medical imaging and laboratory tests.

But some U.S. orthopedic specialists say they have already reached their own conclusions about metal hips.

"In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective," said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.

The FDA's deliberative approach to tackling the hip implant issue is in some ways a necessity. Unlike other countries, the U.S. has no national registry to track the performance of implants over time.

The FDA received 16,800 negative event reports involving metal hips between 2000 and 2011, but regulators stress that number is not very useful. Many doctors do not report problems to the FDA, and the volume of reports is influenced by news reports on safety issues.

A registry set up by Minnesota's HealthEast Care System recorded four times as many replacement surgeries for patients with metal-on-metal hips as those with other implant types. However, a similar registry set up by health care provider Kaiser Permanente found no difference between the two groups.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the effects of metal particles that often seep into the bloodstream as the implants wear down.

But Sedrakyan and others say it could be a decade or more before that information is available. In a commentary published last week in the New England Journal of Medicine, Sedrakyan and two co-authors pointed out those studies must run at least eight years to return the information FDA is seeking. Based on the authors' analysis of FDA records, the FDA has reached agreements on the design of less than 25 percent of the studies, and it's unclear whether any of the studies have actually begun. The FDA notified the companies last May.

The prospect of safety findings arriving in eight or 10 years is little comfort to patients like Mary Weaver, 48, who had both hips replaced with a metal implant from Johnson & Johnson in 2007 and 2008. J&J recalled the ASR hip replacement in 2010, after reports that it was failing in some patients after only a few years of implantation.

Due to increasing pain and elevated metal levels in her blood, Weaver had both implants removed in 2011. She was let go from her job due to the time needed to undergo both surgeries, and is currently unemployed.

"I hope that no one has to go through this ? it's frustrating, it's emotionally draining," said Weaver, who lives in Mount Jackson, Va. "It's not just hard on you, it's hard on your whole family because your quality of life is not what it used to be."

Like 90 percent of medical devices sold in the U.S., most metal-on-metal hips were approved via the FDA's fast track program for medical devices. Under the so-called 510k system, the agency waives clinical testing requirements for devices which appear similar to others already in use. Since plastic and ceramic hip replacements had been on the market since the 1950s, most metal hip replacements were approved without new clinical testing.

"I am so furious they would use my wife as a lab rat, along with the other 500,000 people who don't have a clue what is happening," said Dwight Schrag, 69, of Bellevue, Wash. Schrag's wife Mary received J&J's ASR hip in 2006 and had it removed due to pain and other side effects in 2010. Schrag is one of a number of speakers who have signed up to speak during a public comment session at the FDA meeting.

It's not the first time the FDA's fast-track program for clearing devices has come under fire.

Last summer the Institute of Medicine said in a report that the FDA should abandon the 35-year-old system because it provides little assurance that the implants are actually safe. The Institute is composed of medical experts who advise the federal government.

Although the FDA itself requested the report from the Institute, agency officials rejected the group's conclusions, saying the 510k system works well for the vast majority of devices.

Associated Press

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Make A Three-Minute Call, Help Develop A Test For Parkinson?s Based On Voice Recognition

At TEDx Edinburgh today, the BBC reports, mathematician Max Little has launched a new project that uses a speaker's voice to help diagnose Parkinson's disease. Parkinson's, a devastating progressive neurological disease that develops very gradually and often starts with a very slight tremor in one hand, is notoriously hard to diagnose as there are currently no blood tests that can help doctors test for the disease. The human voice however, says Little, is affected as much by Parkinson's as limb movement and his algorithms can currently detect the symptoms of the disease with 86% accuracy. Little recently became a TED Fellow and is now working to improve the accuracy of his algorithms. He hopes to make his tools available to doctors within the next two years. If you have three minutes, you can even help him in his mission by making a simple call to an automated system that will ask you to answer a few questions and repeat a few sentences. Besides in the U.S. (1-857-284-8035), the team is also offering call-in numbers in Brazil, Mexico, Spain, Argentina, Canada and the UK.

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Paraguay leader tries to quell diplomatic fallout

ASUNCION, Paraguay (AP) ? Paraguay's newly sworn-in president set about forming a new government Saturday as he promised to honor foreign commitments, respect private property and reach out to Latin American leaders to minimize diplomatic fallout and keep his country from becoming a regional pariah.

In a brief appearance before international journalists, Federico Franco tried to broadcast a sense of normality a day after lawmakers overwhelmingly voted to kick President Fernando Lugo out of office.

"The country is calm. I was elected (as vice president) in 2008 by popular vote. Activity is normal and there is no protest," Franco said.

His first two appointments were Interior Minister Carmelo Caballero, who will be tasked with maintaining public order in this poor, landlocked South American nation, and Foreign Minister Jose Felix Fernandez, who will immediately hit the road to try to appease fellow members of the Mercosur and Unasur regional trade blocs.

"Our foreign minister will go to Argentina, Brazil and Uruguay to meet with authorities and explain to them that there was no break with democracy here. The transition of power through political trial is established in the national constitution," Franco said.

The Paraguayan Senate voted 39-4 the previous day to dismiss Lugo a little more than a year before his five-year term was to end, and Franco took the oath of office soon after. Lugo's ouster drew swift condemnation around Latin America from leaders who called it a de facto coup, and several presidents said they would seek Paraguay's expulsion from regional groups.

"This goes beyond Fernando Lugo. It goes beyond Paraguay. It's about true democracy for all of our America," said Ecuadorean President Rafael Correa, adding that his country will not recognize the new government.

Cuba called it a "parliamentary coup d'etat executed against the constitutional President Fernando Lugo and the brother people of Paraguay."

Criticism came not just from the left but from conservative governments, too.

Chile said Lugo's removal "did not comply with the minimum standards of due process," and Colombian President Juan Manuel Santos said "legal procedures shouldn't be used to abuse. ... What we want is to help stability and democracy be maintained in Paraguay."

Given the tough talk, Franco could find mending fences to be a tall order.

"It looks terrible throughout the region," said analyst Adam Isacson of the Washington Office on Latin America, a think tank. "It (Lugo's ouster) doesn't look like a deliberative process, and what it looks like is that a president can be removed simply for being unpopular, or making unpopular decisions."

"The new government is going to be pretty isolated for the whole time that it's in power," Isacson said. "For Paraguay's neighbors and trade partners, I think there's probably not great cost involved in isolating the country for a year or more, and then re-recognizing whatever government is elected next year."

That would be a scenario similar to what played out in Honduras following the June 2009 ouster of Manuel Zelaya, which was also portrayed by those who took over as a legal, constitutional transition, even as it was denounced elsewhere.

Honduras' interim president was isolated by many Latin American governments, and his elected successor, Porfirio Lobo, only really got in the good graces of some in 2011 after Venezuela's Hugo Chavez brokered a reconciliation deal with Zelaya.

Lugo resigned as a Roman Catholic bishop to run for president in 2008 against the wishes of Pope Benedict XVI, who grudgingly accepted the resignation when it became clear Lugo would not be dissuaded.

On Saturday, the Vatican's envoy to Paraguay stopped short of recognizing the new government but expressed satisfaction there has been little unrest other than some confrontations between Lugo supporters and police during the Senate trial.

"I am very pleased that the people and authorities have thought of the good of the country, which is to keep giving one's best for the fatherland," Antonio Ariotti said, adding that he would read a message from the Vatican in the evening.

The German ambassador was also seen visiting the presidential palace.

"We will continue as normal with all cooperation agreements with Paraguay. We see the process of change happening within the laws and the constitution, because no parliament makes a coup d'etat," Ambassador Claude Robert Ellner.

The U.S. State Department urged "all Paraguayans to act peacefully, with calm and responsibility, in the spirit of Paraguay's democratic principles."

At Lugo's home in a quiet residential neighborhood of Asuncion, a close political ally said the former priest would not be making any comment Saturday.

Lugo was in good spirits, had spoken by phone the previous night with leaders like Chavez, and was now focused on moving his things out of the presidential residence with the help of his nephews, said Sen. Alberto Grillon, one of the four to back Lugo in Friday's vote.

Lugo had locked horns with a virulent opposition from the beginning of his term in 2008. He was criticized by some as being unyielding and unwilling to compromise; meanwhile Paraguay's powerful elite, long accustomed to getting their way during 61 years of Colorado single-party rule, fought Lugo's attempts to raise taxes on No. 1 export soy and redistribute farmland to the poor majority.

There had been talk of impeaching Lugo in the past, but there was never enough support in congress for such a drastic step. Ultimately, a deadly forest clash between police and landless protesters cost Lugo all but a handful of votes in both legislative houses, setting the stage for his rapid removal.

___

Associated Press writers Pedro Servin in Asuncion and Ian James in Caracas, Venezuela, contributed to this report.

___

Follow Peter Orsi on Twitter at www.twitter.com/Peter_Orsi

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South Korea's Park opens two-shot lead in Waterloo

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Lonesome George Dead: Last-Of-His-Kind Galapagos Tortoise Dies At 100

* Giant tortoise, 100 years old, was a symbol of the Galapagos
* Galapagos park may decide to embalm his body
By Alexandra Valencia and Eduardo Garcia
QUITO, June 24 (Reuters) - Lonesome George, the last remaining tortoise of his kind and a conservation icon, died on Sunday of unknown causes, the Galapagos National Park said. He was thought to be about 100 years old.
Lonesome George was found in 1972 and had become a symbol of Ecuador's Galapagos Islands, which attracted some 180,000 visitors last year.
"This morning the park ranger in charge of looking after the tortoises found Lonesome George, his body was motionless," the head of the Galapagos National Park, Edwin Naula, told Reuters. "His life cycle came to an end."
George was believed to be around 100 years old and the last member of a species of giant tortoise from La Pinta, one of the smallest islands in the Galapagos, the Galapagos National Park said.
The giant Galapagos tortoises, which can live up to 200 years old, were among the species that helped Charles Darwin formulate his theory of evolution in the 19th century.
The Galapagos National Park is considering embalming George's body so that it can be displayed in the park, Naula said.
A spokesperson said the park plans to carry out a necropsy to determine what may have killed the tortoise.
Scientists had been trying to get George to mate since 1993, when they introduced two female tortoises of a different subspecies into his pen. They laid eggs twice, but they were infertile.
The pen where George lived was visited by thousands of tourists every year, who often had to scramble with each other to take pictures of one of the rarest creatures on Earth.
The islands often attract celebrities, including Angelina Jolie and Brad Pitt earlier this year.
Tortoises were hunted for their meat by sailors and fishermen to the point of extinction, while their habitat has been eaten away by goats introduced from the mainland.
Some 20,000 giant tortoises still live on the Galapagos. (Editing by Sandra Maler)

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