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Questions raised about Dr Pazdur's decisions at FDA for anemia drugs made by Amgen and Johnson and Johnson. Dr Pazdur is head of the FDA office that regulates oncology drugs, all cancer drugs. Dr Pazdur's review process and decision shows how reviewers are human and their own experience helps determine what they see prominently. His experience with his father who suffered severely from the side effects of steroid drugs would make him aware of the the other effects of drugs. He is an oncologist, his wife is an oncology nurse, and some relatives have died of cancer, so he has lived with cancer patients. It appears from close associates that he like open communication and hears all sides but makes the final decision himself. He had an experience with a drug for lung cancer Iressa made by Astra -Zeneca, which the FDA approved based on testimonials, but not enough statistical evidence, which later failed and approval had to be withdrawn. This may have made him more inclined to look for strong results and statistical evidence before concluding on the safety and effectivenes of a drug. An approach evident with Amgen's anemia drug. It also appears that the FDA is not clear on whether the drug's effectiveness is to be judged by what result, is it whether it prolongs life only that counts, or whether the effectiveness in relieving significantly the symptoms of a patient even if life is not prolonged. There is the controversy surrounding the FDA's rejection of a drug by Genta Inc Genasense that relieved patient symptoms for leukemia but did not prolong their life. These and other questions continue to give sleepless nights to people at the FDA and outside as the drug review process faces difficult balancing act between what to give importance and what direction to take with a drug in patient's interests. In Dr Pazdur's case this is made more difficult as he thinks every day of his father who died in 1979 and suffered from the side effects of steroid drugs, went blind when Dr Pazdur was only a teen, and had pulmonary fibrosis and diabetes. He is described by doctors who trained under him as gentle but did meet a patient's eyes and tell him that he had to come to terms with his disease. ...

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Colonel Stevenson's efforts to limit features on a new bomber for the U.S. Air Force to replace aging B-52's and B-1's. Contractors added a kitchenette in one design which was turned down by Stevenson and senior officers at the Air Force. Senior officers were mindful of how it might be seen by the public and aware of the need to keep costs down during a period of austerity budgets. Barnes describes the efforts of Colonel Stevenson as he led efforts to limit the new plane to essential features, turning down contractor proposals for a plane that could be converted into a drone, reconaissance and cyberdefense features, and other embellishments that would drive up the price tag per plane. In 2011 budget negotiations defense officials agreed to limit the cost to $550 million per bomber, a third of the cost of the B-2 which cost $1.8 billion per plane. Because new planes take a decade or more to design and build with cost overruns, it is also important not to venture too far into technological unknowns. This adds more time to build and proves costly. The Long-Range Bomber project started in 2011 with Secretary Gates signing off on the requirements for it to give the president the option to move quickly in a matter of hours to penetrate distant airspace. The cost is $600 million spent till Oct 2013 for research, and $8.7 billion budgeted to 2018. The Air Force is sticking to existing engine design, and Stevenson says if the technology has not been tested the Air Force is not interested in experimenting with it. In the process Stevenson finds himself trying to change the culture at the Air Force, where putting cost as the top priority is a new concept....

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Douthat offers insights into U.S. president Obama's thinking when he said at a National Prayer Breakfast, that Christians also had committed bad acts in the name of religion and reminded listener of the Jim Crow days when blacks were oppressed by church going Christians. The Crusades were a long battle against an advancing Islam over several centuries and many regions, says Douthat, and do not quite compare with the actions committed by an individual organization such as Islamic State in 2014-2015. The Jim Crow reference comes from personal experience during the fading days of racial discrimination. Yet says Douthat this reference to Christian culpability does little to bring the criticism back to self that the writer Niebuhr, Obama's role model, suggests, because it does not take the criticism back to self or political party to serve as useful introspection. It is almost like saying Christians are just as bad,(so why act?) without distinguishing from Christians and Muslims who respect tolerance and peaceful coexistence from those who do not. It also encourages one to remain a bystander in foreign and defense policy, leaving a younger generation with any future consequences. Ike does better by bringing self-criticism home to his own party and ideological wing by talking about the military-industrial complex and the problems it will create....

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A former Wall Street trader says banning bonuses for investment bankers would take out much of the risk in the financial system. The current system is different from the one he joined as an intern in the 1980's, he says. At that time banking was a bland business, where the head of a financial firm made about the same as a junior trader makes nowadays. Large bonuses of today were rare at the time. What large incentives to take risk in the form of bonuses do is to encourage extreme risk taking, especially when the downside or pain as a consequence of these decisions is passed on to other individuals or institutions, or the government.

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Congressional Budget Office figures show the share of government benefits going to the bottom fifth of American households in income declined from 54% in 1979 to 36% in 2007.

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Robert Morgenthau, District Attorney for Manhattan, 1975-2009, says there is more money on deposit in the Cayman Islands, than in all the banks of New York put together, with 19,000 companies listed there. Cayman is one of several tax havens. Apple use Luxembourg for iTunes. Other tax havens are the British Virgin Islands, Gibraltar, Antigua, Bermuda, the Bahamas. He cites the Senate's Permanent Sub-Committee on Investigations in 2008, which gives the estimate of $5 trillion to $7 trillion sheltered in offshore places on this list, by Americans, Chinese, Europeans and others. Morgenthau says these tax havens help American and European companies not only to avoid taxes, but also structure complex international transactions. He estimates these transactions cost the U.S. Treasury about $40 billion from outright tax fraud each year.

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A look at the history of the founding of Pakistan and the 60 years since, looking all the way back to Muslim League's activities in the 1930's under Jinnah, and the failure of politicians and the military to help build Pakistan and improve the lives of its people. One by one the generals and the politicians, including Ms Bhutto and Sharif, have all failed and the dim prospects that it would be different this time with a new elected government.

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The Public-Private Investment Program of the U.S. Treasury Department has not had a good start. With most banks passing the U.S.government's stress tests and raising $50 billion in the markets, PPIP which was intended to to help resolve the situation of all the toxic securites siting on the bank's books, has gone the way of all the prior efforts to solve this problem. Simply postponed this time hoping that the housing market recovers. With the Rogoff-Reinhardt study showing that it takes about 6 years or longer before housing recovers from such aserious crisis as this one, it would be 2012, before one sees an improvement. See the link to the Business Week analysis that shows housing markets in the USA having some aspect of normalcy in 2012. Yet even this analysis is using an optimistic scenario, because it assumes Moodys Economy.com estimates of economic growth for GDP of 4-5% in 2011- 2012. This assumes the consumer debt that has reached over 100% of GDP will be reversed quickly in 2010, and the the factory capacity utilization currently at 68% and expected to drop further in 2009- with more automobile manufacturing capacity remaining to be scrapped -will recover quickly in 2010-2011. This is unrealistic considering the combination of factors at work. Here Devin Leonard talks to PIMCO chief Bill Gross, who with Warren Buffett and PIMCO CEO Mohammed El-Erian, are key proponents of the PPIP program. Both El-Erian and Warren Buffett say they conceived independently of such a program, in which toxic securties are taken off bank's books with government help. As PIMCO is one of the largest traders of mortgage bonds in the country and has years of successful experience in dealing with mortgage bonds, the New York Fed under Geithner turned to PIMCO for advice in 2008. By this time PIMCO was under ownership of Allianz, a German insurer, which bought PIMCO for $3.3 billion in 2000, with $233 million and a $40 million retention bonus going to Bill Gross. Bill Gross describes how the program would function. PIMCO puts up $500 million, and Treasury matches this with $500 million. Analysts estimate that this partnership would be able to attract as much as $ 4 billion in low interest financing from Treasury and the Fed. Gross says that some of these securities pay as much as 14% interest, and even with a 70% default rate, this partnership could make $250 million a year on the $5 billion partnership, or a 5% return, with PIMCO making a 25% return on its original investment. This isn't exactly pro bono work as Buffett had originally suggested to Bill Gross in the midst of the crisis. But a more fundamental concern is that no one really knows exactly how much of toxic securties the banks have on their books, even though estimates have been made. If this is closer to $1 trillion, PIMCO's expertise and efforts will simply fall short of dealing with a problem of this size, and the window dressing of a problem of this magnitude could only hurt efforts for the eventual resolution of this problem. If housing does not recover as is expected till 2012 at the earliest, and the economy continues to deteriorate in unemployment and factory utilization, then the toxic securities on the bank's balance sheets may pose a bigger problem that will require serious action....

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Duke Energy's CEO, Jim Rogers, talks to Charlie Rose about the U.S. nuclear industry and the future for nuclear energy in the aftermath of the nuclear disaster in Japan.

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Japan's Foreign Minister tells Martin Fackler of the NYT in an interview that the Abe government will follow previous governments in the postwar period that apologized for colonial policies that caused suffering in other parts of Asia. He repeatedly calls for Japanese to be humble about the past. Previous statements by persons seen to be close to the government, including the head of NHK broadcaster, were interpreted negatively in S. Korea, China and the U.S. as needlessly escalating tensions in the region. China and S. Korea responded with a public relations campaign of their own to present what happened in the prewar period. S. Korean president Park refused to meet Japan's premier Abe. Kishida used NYT and Fackler to send a message to a global audience about Japan taking a path of peace since 1945.

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The Obama administration is pushing for new U.S. fuel efficiency standards of 56.2 mpg by 2025. In May 2009 President Obama announced domestic car and light truck fuel efficiency standards of 35 mpg by 2016. Europe is expected to reach fuel efficiency of 60 mpg by 2020. This would still leave Europe considerably ahead of the U.S. in fuel efficiency for automobiles, but the gap would be much smaller. For the last several decades the U.S. has fallen sadly behind Europe and Japan in fuel efficiency. The perception of poor fuel efficiency hurt the automakers badly during periods of high fuel prices and when buyers were facing difficult economic choices. The automakers are beginning to grasp this fact. Mark Reuss, president of General Motors, commented that- "it's very challenging, but its upto us engineers to provide high value to the customer and support the environment." This is an issue that has serious national and global implications as it affects the future prices and demand for oil, emissions, and future economic growth. It would also bring the U.S. in line with Europe and Japan when it comes to fuel efficiency of automobiles. ...

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Manuel Barroso, president of the European Commission, tells Italian newspaper La Repubblica on September 1, 2014, that Russian president Putin made some abnormal remarks in a phone conversation. Responding to Barroso's question about whether Russian troops had crossed into eastern Ukraine, Putin is reported to say: "That is not the question... But if I wanted to, I could take Kiev in two weeks." The WSJ editorial on September 3 referred to an earlier editorial on "Putin Bonaparte," giving some idea of how such comments by Putin are seen in the media, and how Putin's actions in Ukraine are creating new tensions with the NATO alliance and the U.S.

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The costs of fraud in medical care from spurious Medicare claims to kickbacks for unecessary services is estimated at $125 to 175 billion. Costs of unnecessary care from overuse to unnecessary lab tests are between $250-325 billion. The amount wasted for on treatment for preventable conditions such as heart disease and diabetes. is $25-50 billion. This number is much higher when all the complications from obesity are figured in. These amounts alone add up to $500 billion. Add to it the problems and the costs of medical errors leading to bad drug reactions or other misdiagnosed procedures which cost an estimated $75-100 billion and the the total is upto $600 billion. These amounts are not going to be tackled by computerization of medical records. The whole manner and ways in which medicine is practiced today and the manner in which the public takes care of its health would have to change for an impact to be made in these numbers.

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Administrative costs are one of the key reasons tution costs have increased to excessive proportions in the U.S., putting a heavy burden on the middle class, reducing social mobility that is an important aspect of postwar progress in Europe and the U.S. by putting college out of reach for millions of young people. This also creates a heavy debt burden for young people- U.S. student loan debt passed $1 trillion in 2012- who are less likely to buy a first home because of years needed to repay student loans. The market pressures to control costs do not exist in the same way as industries such as automobiles, because of the demand for college education in a modern globalized economy. Douglas Belkin and Scott Thurm have provided an indepth look at the University of Minnesota to show the spending surge and internal tendencies for faculty and bureaucracy to increase spending on hiring, building expansion to compete with other schools, and salaries to support their own within the college and university system, with a passive student community, and passive parent community, and lack of other outside pressures. Tution and fees for state residents doubled in the last decade at the University of Minnesota to $13,524. The figures tell the story- total debt with borrowing for building construction at U.S. 4 year public colleges tripled to $88 billion between 2002 and 2011, according to the Department of Education. Debt servicing costs doubled at the University of Minnesota to $106 million in that period. Minnesota's government provided $570 million for university operations in 2011, same as 2003-2004 school year even with inflation and 10% higher student enrollment. Yet analysis by the Department of Education and the Wall Street Journal shows in that period the spending increased disproportionately compared to inflation, student enrollment and teaching activity, with little restraint. WSJ analysis showed the University of Minnesota system added 1000 administrators between 2001-2011, with administration hires increasing 37%, double the increase in the students and double that of teachers. During that period the number of employees to manage people, programs and regulations went up 50% faster than the number of instructors, according to the Department of Education. Bureau of Labor Statistics cites this as the reason tution costs went up faster than health care costs. The 19,000 employee payroll at the University of Minnesota means one employee for three and half students. The new university president in 2011, Eric Kaler, interviewed by WSJ's Belkin and Thurm, says no one knew what it cost to run the school when he started....

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Asli Aydintasbas's thoughts on President Obama's visit to Turkey. He is a Turkish journalist for the newspaper Sabah. He says something useful. In Turkey's eternal identity crisis where the thinking is going on only in terms of opposites, either you are secular or religious, Kurd or Turk, European or Middle Eastern. Obama's visit and his careful remarks point to a more abiding truth he says, that Turks should remind themselves that they are all of those things, and much more.

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Actually some of this is a healthy development as more nations and people have a stake in the world economy. Take the Brazil situation for example . Clearly the Brazilian people are more favorable to globalization and its benefits than they were a decade ago at the height of the Asian crisis and the contagion effect on Brazil. Actually the advantages of free trade and a global trading system that benefits Brazil as well as China and India and other countries that buy its commodities such as iron ore is more now than ever because these nationas are benefitting from this trade. Because of the high prices of commodities and the agricultural products of Brazil, it has a currrent account surplus and its currency is strengthening. Instead of having to go to the IMF for assistance Brazil has large foreign exchange reserves that support its currency and which help it push up its investments as a share of GDP from 19% to closer to 25%, which should enable it to sustain about 5% growth year after year., according to Sergio Vale of MB Associados. A strong real, lower interest rates, and consumer credit have boosted the purchasing power of the middle class and the antipoverty programs of the Lula government have helped the poorer classes have a stake in the development. According to a recent Observador/Ipsos survey 23 million Brazilians have left social classes D and E and joined class C whose distinctive markings are a rented apartment, a car and some new gadgets. Actually quite to the contrary of the impression created by this article Brazil according to a former central bank governor is now showing a new enthusiasm for this kind of development which encompasses free trade and markets, a feeling that the stockmarket is not a casino and being part of the world economy is a good thing. The big discoveries of oil at Tupi and Carioca-Sugar Loaf in Atlantic offshore waters by Petrobras even though they are in miles deep waters and require special expertise must only have reinforced this mood. The danger to Brazil's enthusiasm comes not from nationalism of different countries trying to find better ways of meeting the aspirations of their people but from the risks in a global slowdown that started with the US subprime and mortgage crisis, the resulting credit tightening, and fall in consumption thats expected after years of overspending by the American consumer. Its now upto these individual countries, like Brazil, China, India and Russia, Japan as well as Germany France and other countries that are not directly part of the housing bubble and subprime and mortgage securitization mess affecting the USA, and the UK and Ireland and Spain to a lesser extent, to find ways of maintaining more modest but still substantial growth to meet the growing aspirations of people in these countries. In this sense the policy errors and regulatory errors made during this last decade in the US will actually have hurt the world economy and markets in a serious manner, and it is this that has now to be managed in a better way by these countries with the close cooperation between them and the USA. The situation in Brazil is repeated in the experience of India, China and Russia where for the first time there is enthusiasm for being part of the world economy. In the light of this development there is more reason for hope and more need for careful navigation mechanisms for these and other countries to weather the difficulties from a global slowdown and still sustain development that itself could help the USA work its way out of the current crisis through its exports....

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With majorities in both houses of parliament Lopez Obrador now has the mandate to come up with an independent position for Mexico on issues of NAFTA negotiation, and social programs to lift Mexico's poor and working class, come up with a new way to reduce violence and corruption in society.  Stakes are large in the relationship with the U.S. Mexico exported $340 billion of products to the U.S. and imported $276 billion in goods. The team of Mr. Obrador sees the need to plan conversations with the U.S. carefully recognizing that Mr. Trump is not a lunatic, but a man with a political plan, says Marcelo Ebard, a top adviser to Obrador. On migrants even as Mexico has detained 76,000 central American migrants Lopez Obrador sees Mexico as a nation of refuge, and says migrants rights must be respected. On NAFTA Obrador supports the current negotiations and will have his advisers present at the negotiations. Obrador says Mexico is a country with a lot of natural resources and wealth, so that "the demise of the existing NAFTA will not be fatal for Mexicans." ...