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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 Pakistan army and its anti India mindset is at the root of the problem Pakistan faces. The army has factions that support the Taliban. Its intelligence agency, the ISI, helped create the Taliban as a way to get strategic depth (as they called it) in Afghanistan, for it sees as a necessary perpetual conflict with India. And the failure in Pakistan, the crisis of Pakistan, lies in the failure of elected politicians, the failure of the army, to provide responsible government and peaceful relations with India and with Afghanistan. By pursuing a Hindu-Muslim conflict agenda, and a anti-foreigner agenda for Afghanistan, Pakistan has ended up undermining its own government, institutions, and sovereignty over tribal areas and the North West Frontier Province. The US by getting involved in the Hindu-Muslim conflict agenda, and the anti-foreigner agenda during the Cold War, by supplying weapons and aid for this to successive Pakistani military governments, now finds itself as the foreigner in Afghanistan and Pakistan. The Pakistan army's anti-foreigner agenda, now that the Americans are the foreigners, is not something that even the army or the civilian governments can control. The only thing the army knows, and its raison-de-etre, is the protection of the state of Pakistan and an antiIndian, Hindu-Muslim conflict agenda. After 60 years of doing this since its founding the Pakistan army knows no other way. Failure to do what it is doing would remove it from its critical role as the most important institution in Pakistan, and relegate its officers and the army to a smaller role, with smaller committments of resources, a smaller army, and the loss of its privileged role in Pakistani society. This is the answer to Holbrooke's question to Pakistani businessmen, and civilian leaders, in Lahore recently, what is the crisis of Pakistan? And these businessmen and civilian leaders also touched on the army's role. For America as it sees the need to build a new economic partnership with Asia that would help revive economic growth, there is the need for deep soul searching. The Pakistan military sucks up resources that are so badly needed elsewhere, for the kind of construction the Obama administration sees for America, of roads, bridges, schools, new energy infrastructure. How can what is good and planned for America not be whats good for South Asia, for India, Pakistan, SriLanka and the entire region? The resources that are sucked up by the Pakistan military and its actions to foster aconflict atmosphere merely adds to the way resources are sucked for the military in India, when they are badly needed for development, economic growth, and the same kind of infrastructure building and education that the Obama administration plans for the US. Without correcting this flaw in its policies in South Asia the Obama administration cannot create a partnership with Asian countries that could play a critical role in America's own economic growth....

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The WSJ editorial supporting the former WSJ Detroit Bureau chief's position on the editorial pages on November 10, 2008, asking the Bush administration to turn down any request from Congress or the president elect to turn over TARP funds to the automakers. The automakers have problems of not being competitive and making the cars that people want for decades, handing out taxpayer billions will not solve this, and will only postpone the day of reckoning says the WSJ editorial. The union goldplated contracts and things like the Jobs Bank never made sense and neither the union or management acted responsibly. The best thing now it says is to let the shareholders lose whatever value is left, cancell the contracts, and put the companies in government receivership, letting go the old management and the boards that let these companies get to this sorry situation. This is not a time for politics as usual, and if the new administration wants to do it let it do it on its own political dime says the WSJ. ...

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There is considerable opposition among analysts, Congressmen, and experts to continuing with the current management at GM if help is provided to automakers. And GM's management is insisting on staying on which may complicate things. There is a strong perception throughout the country that management has failed the company, and now the economy of the midwest and the country. And some are arguing that bankruptcy or government receivership will be necessary to effect a complete restructuring of the industry after years of failure both by management and unions, the credit crisis having come as the last blow after a long series of mistakes and inability to get things right.

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Micheline Maynard gets diverse views on bankruptcy filing and bailout for General Motors and Ford. Out of hundreds of comments, (looking at the comments based on reader recommends from 70 to 15 readers recommend range), with over 90% of comments favoring no bailout money for automakers without coming to grips with problems and replacing management and the board, it is clear that readers cite in order of importance the following against the automakers. Complicity with Congress and lobbyists in keeping fuel efficiency low. This sent billions of dollars to mideast nations for oil, which in turn bloated liquidity here at home, helping fuel the cheap credit era in the US and building consumer and mortgage debt. This lack of conservation in gasoline use burdened economies around the world with high oil prices, and then hit the car companies in Detroit hard as sales of large vehicles collapsed. Its entirely the Detroit carmakers own shortsightedness they say. Second most mentioned is bad management, and bad decisions and arrogance. Third the unions bloated contracts, and bankruptcy as the only way to get rid of them. Fourth failure to make green cars. Fifth the lack of any idea what $25 or $50 billion given to GM and Chrysler would get the taxpayer, because if the market has collapsed then more money will be needed each year to pay salaries and contiinue operations in 2009, followed by 2010. The market has gone from 16 milllion to a 10 million rate in October 2008, if it drops to 8 million in 2009, it would require the companies to shrink by 50% as a rough guess, and the union contracts just negotiated would be totally inappropriate for the new market and financial conditions. Getting rid of those union contracts could only be done in a bankruptcy filing, as in bankruptcy everything would have to be done from scratch. Whereas in a bailout the unions would simply refuse to cooperate as they have done in the past. This is also what readers are saying when they say let the market economy work. A look at the reader comments on similar articles in the Washington Post and the WSJ also show an overwhelming number of readers not favoring taxpayer money for automakers without serious changes, and bringing a completely new management and board to get things off to a fresh start, with no legacy from the past. ...

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Mexico's growth rate has averaged annual growth of below 2% for 2013-2015 under the Pena adminstration. Predictions were for growth of 5-6%. The investment in the oil industry is low with decline in demand for oil. The peso has dropped in value to 16 to the U.S. dollar in August 2015 compared to 13 in 2014. The popularity rating of the Pena administration dropped to 34% in August 2015.

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Peter Orszag's role in the healthcare debate and the formulation of health care policy proposals. One proposal of Orszag, who heads the Congressional Budget Office, is to set up a new agency with powers to cut spending and implement changes in Medicare. Says Orszag, "one of the reasons we have such disjointed and skewed incentives is that we have an excessively political process." At a recent meeting with House Democrats, one Congresswoman said her top priority is winning higher payments for oxygen suppliers, and Orszag was taken aback. For years officials have been trying to cut payments to oxygen and medical equipment suppliers, which are said to be inflated. When a new competitive bidding process was set to take effect last year, industry supporters in Congress were able to delay the plan, and these supporters are still fighting to block changes says the WSJ. Here is a 40 year old Orszag, with degrees from Princeton and London School of Economics, who got his early experience in the Clinton adminstration at age 24. He then followed this with a number of policy oriented jobs, ending with appointment to head CBO in 2007. And he faces the whole system of Congressmen from both parties beholden to interests in the healthcare industry, who provide the donations for them to finance their election campaigns. Dan Eggen describes this in the Washington Post, 7/21/2009. Max Baucus of Montana, and to some extent Grassley of Iowa, are senators from both parties who Eggen points out are beholden to the healthcare industry because of large donations they receive from the interests in the healthcare industry. These interests want to see their payments system protected. The further escalation in health care costs, which would make the whole healthcare system unaffordable even as it delivers poor results, can only be prevented by making cost control an exercize that is not influenced by healthcare industry donations. Jackie Calmes describes the huge hurdles in achieving a deficit neutral move to universal health care in the U.S. in the NYT 6/26/2009. See the link. The exchange between Grassley and Orszag on the issue of the $177 billion in savings needed from the payments to health insurers under the Medicare managed care plans- which allow seniors to obtain Medicare coverage outside the government run program -went as follows. These are dubbed overpayments by outside experts and efforts have been made to cut them in Congress. When Mr Grassley raised concerns about the impact of such cuts in a hearing, -and Grassley has opposed the cut for this overpayment to insurers- Orszag responded saying: "I very firmly believe that capitalism is not founded on excessively high subsidies to private firms. This is what this system delivers right now." ...

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New Feb. 2024 dated debt issued by Portugal offers investors a yield of 5.20%. In Jan. 2014 Portugal issued 5 year debt for 3.25 billion euros. Plans are to raise 11-13 billion euros through bond issuance in 2014 to build up cash reserves and prefund needs for 2015. Refinancing needs are about 10 billion euros annually according to Moody's. The debt level has reached 128% of GDP by Jan 2014 after GDP declines and aid to struggling companies.

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Angola's recent election gives the country a new president Joao Lourenco. Since independence Angola is governed by the MPLA led by Jose Dos Santos. Lourenco was selected by Dos Santos to help Angola navigate a difficult period when oil prices have fallen. Dos Santos remains a key figure in Angola- his daughter heads the oil company that generates 95% of Angola's export revenues, and his son heads the sovereign wealth fund. Lourenco's wife is an executive director of the World Bank, and helped negotiate a loan from the IMF for $1.4 billion in 2009. Lorenco is a low key figure who started by joining the MPLA in the struggle for independence at the age of 20, and is seen as a person Mr. Santos is appointing as he considers retirement.

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Problems facing India as it searches for a way to modernize the country, build infrastructure, and create strong jobs growth. Glaring weaknesses are evident in a number of areas which have not been addressed: a weak public education system, food poverty for people at the lower end worsening with today's 10% food inflation, child malnutrition, weak infrastructure building capabilities, growth in services but not enough in manufacturing to create jobs, a growing black economy, and a general acceptance of illegal behaviour that has increased with the increase in opportunities for corruption and bribes in a growing economy. The political governance is weak. The dependence on smaller regional parties in ruling coalition governments weakens initiative at the federal government level. The general lack of new political leadership, and the failure to develop new leaders in the Congress party because of the six decades long presence of the Nehru family. Some striking facts- the role of the black or underground economy has actually increased over the years. Arun Kumar, chairman of the Center for Economc Studies and Planning at Jawaharlal Nehru University in New Delhi, says his estimates show it was 40% of GDP by 1996, and 50% by 2006. This means more business activity evades direct taxes, and less money is available for investments in education, infrastructure and healthcare. It also indicates a widespread tolerance of illegal activity and corruption. The other striking facts are that the calorie consumption by the bottom of the 50% of the population has been declining since 1987, according to a 2009-10 economic survey by India's Ministry of Finance. The modernization of the country appears not to be following the path taken in East Asia- by Japan, S. Korea and now China- where people moved in large migrations from farms and rural areas to cities and manufacturing jobs, resulting in gradual urbanization. Manufacturing in India is only 16% of GDP in 2009, the same as in 1991, according to the World Bank. Certain regions are doing better than others- Gujarat and the Punjab in the north, Tamilnadu, Karnataka in the south- with large population areas in Uttar Pradesh and Bihar lagging behind badly. ...

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New legislation introduced in the U.S. Congress by Senators Orrin Hatch and Ron Wyden giving fast track and trade promotion authority to president Obama faces intense opposition from Democratic Party members of Congress. Only about a dozen House Democrats are considered to be supporting the legislation. Senator Schumer says "I don't believe in these agreements anymore, I've changed." Senator Warren on the left opposes the legislation. Senator Bob Casey of Pennsylvania says the legislation "as paving the way for another Nafta style deal that costs jobs." The deal if it passes the Senate, would face Republican opposition in the House where 50 or more Republicans are reported to be against the fast track approach and giving too much authority to president Obama without Congressional input. Fast track legislation would allow free trade pacts such as TPP to pass Congress without amendments or procedural delays. Labor groups and auto, other manufacturing companies, oppose the legislation because of the impact on manufacturing, West Coast groups in IT industries favor the legislation. Projections made by Petri, Plummer and Zhao at the Peterson Institute of International Economics, show the impact of Trans Pacific Pact (TPP) free trade pact would be $109 billion in added manufacturing imports to the U.S. to 2025 and $ 53 billion in exports, a net U.S. unfavorable of $56 billion. For IT and services sector the added U.S. exports to 2025 are projected at $42 billion and imports at $8 billion, for net $34 billion. U.S. favorable. Because of the dominant position of the U.S. in IT how much of this $42 billion might still happen without TPP. Other societal impacts also figure in the discussion, such as which sector needs the largest help and impacts the largest number of Americans for a sustained economic recovery in the future. ...

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WSJ reporters tell the story of Chuck Hagel of Nebraska from his early days in Vietnam, a cellphone business venture, Senator during the Iraq war, gradual shift to opposing the Iraq war, serving on the Senate Foreign Relations Commitee with Senator Obama, and the bond established with Obama over American involvement in the Middle East.

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Chuck Hagel answers questions in the U.S. Senate about his views on the Iraq and Afghanistan surge, on sanctions against Iran, and nuclear disarmament. Hagel says the U.S. must engage not retreat in the world, and discussed his world view without getting drawn into details about policy issues. He faces a difficult nomination for U.S. Defense Secretary with skepticism from Republicans. Hagel opposed both surges and says the right approach is bilateral disarmament for nuclear weapons.

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What Krugman makes of the $1.089 trillion dollar U.S. deficit for fiscal year ending in Sept. 2012. He points out that the U.S. can have a stable to declining debt to GDP ratio with $400 billion debt. He cites the Clinton years (1992-2000) when the debt to GDP ratio declined from 49% to 33% with steady growth. What about the remaining $600 billion. He attributes this mostly to temporary factors which are reversible as growth picks up. Of this remaining excess deficit he says $400 billion is from lower tax payments to Treasury because of the 2008 economic crisis and the recession that followed. This includes the payroll tax cut which is also temporary to keep up consumer spending in the recession. The $150 billion is from unemployment insurance, food stamps, and other aid which is also reversed once growth picks up. He places emphasis on restoring economic growth as early as possible and reducing unemployment and using the recession for business to continue to invest in R&D, productivity, and government to preserve the social fabric, invest in education, and provide incentives for growth. S&P Nov. 8 report says the net government debt to GDP ratio is estimated to be over 80% in 2013. It will have to stabilize at current levels for S&P to preserve the U.S. credit rating, says S&P executive Chambers. The higher debt to GDP ratio in 2013 and lower growth rates expected makes the situation different from the lower debt to GDP ratios during the Clinton period. Britain, France and other major industrialized nations with political parties at either end of the political specrum have also chosen to stabilize or reduce debt to GDP ratios rather than take on the risks of them going much higher. The U.S. has the added problem of health care costs out of control with an aging population and about 17.9% of GDP going to healthcare costs in 2010 expected to increase significantly, as Medicare actuaries estimate enrollee numbers jump to 80 million in 2030 from 50 million in 2012. Democrats and Republicans have largely sidestepped this underlying problem in fiscal cliff negotiations....

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With unemployment at 11% and inflation at 9%, public finances in Rio de Janeiro state dire to the point of delaying payments to public servants,including police and teachers, and corruption scandals affecting most politicians and parties, the mood in Brazil at the time of the Olympics is one of anger and indifference. Ordinary Brazilians feel that the $12 billion spent on the Olympics could have been better spent on education, health care and improving basic public services such as the bus system. The decision to host the Olympics was made by the Lula government at the height of the commodities boom. With the collapse of commodities prices and the debt run up by the federal and local government Brazil faces a contracting economy- a 3.8% drop in GDP in 2015- and rising unemployment, increasing inflation, the climate is very different in 2016.

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A New York Times/CBS poll shows 69% of Americans polled between March 21-25, 2012, feel the U.S. should not be involved in a war in Afghanistan. This is up from 53%, in a poll only 4 months before this poll.

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Asset reports of Fed governors and candidates for Fed chairman show Ben Bernanke and Daniel Tarullo at the low end of $1-$3 million, Stein, Duke and Yellen at $5-$12 million in the middle, and at the high end are Summers $8-$31 million, and Powell between $17-$40 million.