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The use of fast track procedures under 510 K, for approval of Ren-Gen's Menaflex product to treat knee injuries. Under 510K rules for fast track no clinical trials are required, because the product is similiar to already existing products. Menaflex does not have asimiliar product, yet the FDA allowed Menaflex to be treated as fast track. The closest is orthopedic surgical operation, which is quite different. Menaflex is a C shaped pad used to repair a torn meniscus, a rubbery substance made from cow collagen that that acts like ashock absorber between the knee bones. Their is a booming market for meniscus repair among sports athletes. In fact originally Ren-Gen did not even apply as fast track, but only afte its clinical trials ran into trouble, did it try for fast track, which was turned down several times. At which point Ren-Gen got Democrats Senator Robert Menendez, Rep Frank Pallone, Chairman of the Health Subcommittee of the House Energy and Commerce Committee, Rep Rothman of Hackensack where Ren-Gen is based, and Senator Frank Lautenberg to intervene. At this point Senator Menendez and the others wrote to the FDA Commisssioner Dr Von Eschenbach, and Menendez spoke to the Commisssioner personally on the phone. After this intervention things started moving in Ren-Gen's dirtection, bypassing the FDA staffers who had reservations, and a special panel was appointed that again excluded anyone that had reservations, in an unusual procedure, which approved Menaflex. Now Congress and the Obama administration are being asked to review the whole process the FDA uses for medical devices because of the controversy this has caused about what is seen as unfair influence of companies in FDA approval process. Menaflex say those who had reservatoions faces alot of pounding and wear and tear between the knee bones and its safety and effectiveness needs to be proven before approval. It has been approved in Europe for afew years, but only 2800 patients have used it in Europe, only a small proportion of patients, and not enough is known about its effectiveness and any issues. ...

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The India- U.S. trade deal after the negotiations and the visit of the Indian prime minister to the U.S. is expected to take additional time. The U.S. wanted to see a 20% duty on mobile phones and ethernet switches to be reduced, greater access to the Indian market for medical devices such as stents and knee implants, and greater access for dairy, agricultural products. Making these products affordable in India is a goal of the government preventing it from making concessions. India wants preferential access to the U.S. market as a developing country restored under the Generalized System of Preferences.  A comprehensive trade deal would have to include issues of intellectual property, e-commerce, and the sensitive issue of H1B visas. Commerce minister Piyush Goyal led negotiations for India and Foreign Secretary Vijay Gokhale said the two sides "narrowed" down their differences. India's Jio from Reliance Group has hugely reduced the price of mobile phones and mobile data making it accessible with 4G across the country at prices that are the lowest in the world. The introduction of a universal health care program requires bringing down the price of medical products to improve access to modern medicine. This means less room for American products that would increase the price and reduce access in a vast developing country. India is also playing catchup in these technologies so that there is less room for unrestricted entry in the Indian market.  Efforts were made to increase trade and investment in India with the help of Mr. Bloomberg during the visit of the prime minister, and the Bill Gates Foundation continued its commitment to public welfare gains in India in the fields of sanitation, hygiene and healthcare.  ...

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Wounded or maimed veterans get psychological closure by visiting the scenes where theywere injured. Here wounded veterans visit locations in Dyala province under Operation Proper Exit, eight wounded men- five amputees and one blinded soldier- places tey left while unconscious or in agony. This is the second such trip and the results in development, stopping night tremors for the wounded men, and psychological closure have been phenomenal. Rick Kell, head of of Troops First, who got General Ray Odierno to agree to the idea says wounded soldiers said they wanted to go back, and he kept hearing it repeatedly. Sgt. Luke Wilson, 29, from Hermiston, Oregon. He lost his left leg above the knee in agrenade attack in Baghdad in 2004. Kell arranged that they fly in Business Class for the 13 hour flight so they could lie down or take their legs off. When they walked off the helicopters they walked under their own power to be greeted by American officers and soldiers, clapped on their backs and welcomed as old friends. All in uniform and none of their injuries or prostheses visible except up close. Sgt. John Hyland, 38, from San Antonio, who lost his left leg and sufffered back injuries when an improvised explosive device hit his Humvee in 2007, and Specialist Craig Chavez, 29, from Temecula, California blinded by a2006 I.E.D. blast that destroyed his face- which was reconstructed- injuries which meant losing his left eye and most of the vision in his right. Specialist Chavez says it was apoint of special pride for him to walk around the base without any help. And Sgt. Hyland was amazed by the silence, the silence from no sounds of mortar shells going off and exploding L.E.D. devices. In the memorial hall Sgt. Hyland pauses at a picture of Specialist Jonathan Rivadeneira, 22, from Queens, who saved his life in an Humvee attack on Sept. 11, 2007, only three days later Rivadeneira was killed. Sgt. Hyland began crying quietly and lowered himself in pain onto his right knee and began to pray. Outside he was still shaken by the experience and the other wounded soldiers gathered around him till he recovered ....

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Samuelson points to the risks to the American economic growth from excessive health care costs. This is hurting take home pay and shows up in consumer spending. It is hurting government spending in other areas such as needed infrastructure spending and efforts to reduce the deficit. This hurts private capital investment to create jobs because of lower demand from constricted consumer spending. The U.S. budget has as its largest single expense 27% on health care compared to 20% on defense the next largest expense, with growth in health care spending taking this to one third of the budget in coming years. Without addressing health care, says Samuelson, the Supercommitte in Congress even if successful at deficit reduction will basically have failed to do its job, and it did not have the time, resources or conviction to do this. According to a new study from the Organization for Economic Cooperation and Development (OECD), U.S. healthcare spending per person is $7,960 per person in 2009. This compares with Norway $5,352, Britain $3,487, France $3, 978, an OECD average of $3,233. Life expectancy in the U.S. is 78.2 years, compared to Japan 83 years, OECD average of 79.5 years. Chile and the Czech Republic have life expectancy equal to the U.S. Except for cancer care where the five year survival rate is 89.3% in the U.S. and the OECD average is 83.5%, the U.S. lags far behind in much needed critical areas such as diabetes and asthma. Rates of emergency hospitalization for asthma are 3 times that in France and 6 times that in Germany and Italy. The U.S. has fewer doctors per thousand population and higher cost per medical procedure- with more frequent use of the costliest procedures- creating a supply shortage that induces higher prices, and less preventive and early action care through physician visits. The number of practicing U.S. doctors is 2.4 per thousand population in the U.S. compared to 3.1 per thousand for the OECD average; and number of annual doctor consultations 3.9 per capita in the U.S. versus 6.5 for the OECD average. Appendectomy cost $7,962 in the U.S., $5,004 in Canada and $2,943 in Germany. Coronary angioplasty cost $14,378 in the U.S., compared to $9,296 in Sweden, and $7,027 in France. Knee replacement cost $14,946 in the U.S., $12,424 in France, and $9,910 in Canada. Knee replacements, angioplasties and MRI exams are twice as common in the U.S. compared to the OECD countries. ...

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Liz Whitehurst is one of many young people who are giving up jobs in offices to take to farming. They are not from farm families and bring a new way and exciting way of looking at farming free of the pesticides and other practices common today. Only 2% of U.S. land is being used for growing fruits and vegetables, according to the Union of American Scientists cited in the Guardian newspaper, and this needs to at least double in acreage if American needs are to be met. Only 15% of Americans get the daily requirement for fruits and vegetables- so desperately needed is this  to lower the BMI of the 70% of overweight Americans with BMI over 50. In the light of this crisis the shift of young people to farming is an encouraging sign.  In 2015 Liz, 32 years, decided to buy a 3 acre farm in Upper Marboro, Md, giving up benefits and better pay at nonprofit jobs in Washington state.  Here she is shown picking up Aragula leaves in the November chill. She is not alone. She is joining a movement that is bringing highly educated, former urban first time farmers as the demand for better food, for local and sustainable food, especially fruits and vegetables grows in the U.S. Year on Year there is a 20% increase of farmers in states like California, Nebraska, South Dakota in the 25-34 age group. In the 2014 USDA Census this group is growing at 2-3% just when other groups are shrinking by double digits. These farmers are more likely to connect with the community supported agriculture (CSA) prorams and markets, to grow organically and limit pesticide and fertilizer use. They tend to have farms less than 50 acres. Liz leases the house and the fields from a neighboring couple in the 70's, growing organically certified peppers, cabbages, tomatoes and salad greens kale to aragula, rotating fields. On Tues, Thurs. and Fri. she and two friends are to be seen waking up in the early hours of darkness to kneel in mud and cut the greens. What motivates them is having a positive impact, to do that so it is immediate and you can see it making a difference, says Liz. Still young farmers face many hurdles, including student loan debt, and finding ways to meet the larger needs for online grocery service or the grocery chains. Yet a trend is taking shape for small and middle farms that provides some optimism as the number of farmers shrink significantly overall. Most alarmingly it is the lack of national and local policies to meet the health crisis of rising BMI's right at this level of local farms and community farms for local produce. Lack of any consciousness about this, even though good health in the U.S. as in other countries has always rested on what you are eating, long before processed foods became the norm this is the way the world met nutrition needs.    ...

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American tennis player Doris Hart from the University of Miami once played three Wimbledon finals in one day because of rain delays, winning all, in 1951. She made up for lack of speed on the court because of leg and knee issues with finesse, using drop shots and a strong serve with an all court game to win. Her story is unique because she spent many years as a child recovering from a bone infection, called osteomyelitis. At one point a specialist even suggested amputation because of the infection. She recovered and went on to win titles in Australia in 1949, France 1950 and 1952, Wimbledon 1951, and the U.S. 1954 and 1955. Her view of today's tennis game is that not much strategy is brought into the game compared to an earlier period, making it less fun to watch. Her story of recovery and persistence is similiar to the story of Glenn Cunningham, one of America's fastest runners, who broke the world record in the 1500 metres at the 1936 Olympics, and became the fastest miler in the world in 1938. Cunningham from the University of Kansas had leg issues because of burns suffered when he was 8 years old from a fire. Doctors recommended amputation at one point for the infection. Doris Hart says in her autobiography, "Tennis with Hart," never to let despondency take over, to respond with faith, courage and patience....

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German chancellor Angela Merkel arrived for a meeting of eurozone leaders in Brussels on October 23, 2011. She said: "I believe that now we have reached a more realistic view of the situation in Greece and that we will provide the necessary means to be able to protect the euro." Germany has insisted that bondholders take writeoffs of between 50-60% of Greek debt so that Greece would have sustainable debt. A review of Greece's debt by the European Commission in coordination with the ECB and the IMF shows that Greece's debt situation is totally unsustainable and will require a bondholder writeoff of around 60%. according to that report a 60% writeoff for bondholders would be required to bring Greece's debt below 110 percent of GDP by 2020. This has supported the German "realistic" view and Jean-Claude Juncker of Luxembourg, who heads the euro group of finance ministers stated that "we agreed yesterday (Friday, Oct. 21) that we have to have a significant increase in the banks' contribution." France also backed away from the plan it was supporting for the European Financial Stability Facility (the fund established to lend to troubled countries) to borrow from the European Central Bank, something Germany opposes. French finance minister Francois Baroin, said the issue was "not a definitive point of discussion for us,... what matters is what works." The Dutch support the Germans on these issues and Dutch finance minister, Jan Kees de Jager, said the use of the European central bank was "no longer an option." Options being considered are for the European Financial Stability Facility to offer insurance against a portion of losses on Italian and Spanish bonds....

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A Syrian opposition group describes the mislabeling of opposition groups in Syria by the Obama administration.

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President Obama's proposed legislation for the fight against Islamic State proposes a three year effort with use of Special Commandos, but no major ground combat effort. It also rescinds a broad Bush era 2002 legislation for the Iraq war, but leaves in place 2001 legislation for the war against al-Qaeda and affiliates.

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One military expert says even if half of the Iraqi army can be put in shape it could turn the tide against the ISIS. Advice from U.S. military experts is for the Iraqi army to focus only on the ISIS and avoid hurting relations with the Sunni population. Advisers are seen as making a difference and needed also for the tribal forces. A major difficulty is that Shiite militias and advisors from Iran play a role in the forces loyal to prime minister Maliki. Following the U.S. training of the Iraqi Army at a cost of over $25 billion there was a period under prime minister Maliki when he appointed officers more for loyalty than for military skills and training. With the U.S. withdrawal the Iraqi Army languished in this situation. Reporters from NYT and WSJ have documented extensively the weakness of the Iraqi Army in commanding officers, in training and in equipment.

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Richard Cohen, Washington Post reporter, on the "no fly zone" option in Syria and how it could have prevented the loss of 300,000 lives, prevented millions of refugees, and moving politics in Europe in a direction that reverses the gains made in the post war period towards a more tolerant society.

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This editorial in the Wshington Post is sharply critical of the Obama administration's policies of inaction in Syria and Iraq. It says president Obama and his administration will have to answer for the policies to the American people and the people of the Middle East and Europe.

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Ben Van Heuvelen documents in the Washington Post what Ali Nabhan and Bradley pointed out in the WSJ in May 2009, that the officers in the Iraqi army lacked the training and discipline to act as an effective fighting force. These early indications proved correct and were ignored by the Iraqi government and the Obama administration till it was too late with the fall of Mosul and the ensuing chaos in Iraq.

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Nour Malas and Joe Parkinson report from the town of Makhmour, retaken by Kurdish Peshmerga forces following airstrikes on ISIS militant positions. The crisis situation 20 miles from Erbil, capital of the Iraqi Kurdistan region and the coordination between Iranian advisors, U.S. military advisors, and the Peshmerga to push back the ISIS. Peshmerga say young Sunnis in the town joined the ISIS in droves, something never seen before. It also reveals the situation after the failure of the Maliki administration to build a state with support from all parts of the Iraqi population- Shiite, Sunni, Kurds and tribes- leading to the radical alienation of Sunnis. The late awakening of Iran, the U.S., and moderate Iraqis both Sunni and Shiite, to the dangers of the Maliki policies. The unraveling of the decade of Iraq rebuilding by the U.S. in such rapid manner leads to the stepping down of Maliki and beginning of a new non-sectarian approach and policies. The vacillating in the Obama adminstration's policies towards Syria and Iraq leads to a lack of direction in the region. ...