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FDA and the cholesterol drug Cordaptive which the FDA rejected

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A ZDF poll in Dec. 2016 shows 64% of the German people support chancellor Merkel's decision to run for fourth term. Of CDU supporters 89% support Merkel. If the election were held today CDU/CSU would win 36%, SPD 21%, Greens 11% and FDP 5%. Schulz is a lot more popular than Sigmar Gabriel in the SPD. About 51% of the German people support Martin Schulz, current head of the European parliament, Gabriel gets only 29%. With SPD supporters Schulz has 64%. Merkel could form a government with Greens and FDP support. See the related article on Greens and CDU positions coming closer.

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France per capital GDP $46000 compares to Mississippi's $55000- productivity and quality of life in the US vs France -healthcare, pharmaceutical, and vacation time, the serious drawbacks in the US. Lower taxes in the US yet the difference easily evaporating with expensive cost of healthcare and pharmaceuticals in the US, lack of maternity leave and health supporting vacation time.

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The US economy grew at 2% in the third quarter 2010, compared to 1.7% in second quarter 2010. Unemployment remains at 9.6%, and the growth did not generate hiring. Much of the growth came from business building inventories, exports grew at 5%, imports rose 17%. Residential construction plunged, state and local government spending contracted as it did for 6 of the last 8 quarters. This increases concerns about the economy.

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At Lyrarc we pointed out how US president Harry Truman had to persuade the US Congress to get aid to Greece and Turkey bills passed to prevent an imminent Communist takeover with Soviet bloc aid in 1948. Paul Krugman points out that this happened before when FDR had to persuade the US Congress to pass bills for Lend Lease agreement aid to Europe in 1942. Much of that aid was in food and other non military aid because the US arms manufacturing was beginning to ramp up.  Krugman also corrects the former president's statements regarding Ukraine aid that the European have done less. Counting all assistance to Ukraine he says the EU has done more than the US. It is because the arms production in the EU has to be ramped up and the US has arms production factories better prepared in military aid the US has done more in military aid, not overall or in other aid. He also points out that $13 billion FDR got from Congress for Europe in 1942 was 10% of US GDP, whereas Ukraine aid is only one fourth of one percent of US GDP, and much of it going as Mr. Biden pointed out, going into investment in American factories and jobs to supply Ukraine. ...

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America's Ivy League Universities and policy that creates a meritocracy which runs contrary to the vision of Washington,  Lincoln, TR and FDR of access to quality education for all. This is how America thrived and how it retains its vigor and resilience over the last 250 years. The emphasis needs to go back to educating a new generation rather than the mere proliferation of research some of it superfluous to the true goal of educating.

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The Nation's Healthcare takes a huge hit in August 1997 by opening up television to a surge of drug ads. The president is Bill Clinton who reappointed Bush appointment Kessler as the Food and Drug Administration chief 1990-1997. DJT and RFK Jr. are finally tackling issues the Bush and Clinton/Obama Republicans and Democrats failed to bring up or address for the Nation's Health.

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Merz popularity dips slightly as he brings up tough issues such as 4 days work weeks in Germany, Many working part time and CDU calling for restricting part time to workers giving care to elderly, childcare, and for education. The German welfare payments close to minimum wage was an issue in Germany but is declining in significance. Most significant today at 35% is the issue of social inequality. Taxes unfairly distributed at 13%, and the asylum seekers issue at 9% lower today by 2%. On the economy Merz pointed out that- "Prosperity cannot be maintained with a four-day work week and an exaggerated work-life balance." He also criticized the high number of sick leave days at 14.5 average days sick leave per employee per year. Polls in February 2026 show CDU at 26%, SPD at 15%, Greens at 12%, Left at 10%, AfD at 24%, FDP 3% BSW 3%. Popularity in Germany is highest for defense minister Pistorius and next comes foreign minister Wadephul. Merz is less popular but he is raising the tough issues and taking strong action compared to Merkel who was more interested in her personal popularity than what was good for Germany. Also not given credit for action is Merz removing constitutional brake on spending for investing in Germany's infrastructure and defense, and fixing problems left behind by Merkel who neglected infrastructure, digital economy, and defense. ...

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FDA will have 1300 scientists and pharmacologists added to its staff as additions to its 10,000 employees to meet its needs to oversee the safety of drugs being put into the market.

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NHK Proportional representation exit polls for Japan's  2025 elections for parliament show twice the number of people in 20's 30's and 40's voted for Sanseito over voted for the LDP. The LDP is the party that has run Japan's government for mostly all of the past 75 post war years. It is losing its touch with the common man as issues of cost of living, migration, and income mobility affect the Japanese people as they have done in Europe and the US. The two opposition parties are the Sanseito and the Democratic Party of the People formed in the last ten years to fight the entrenched LDP governments, and the Constitutional Party of Japan that has acted till now as the main Opposition Party. Not just LDP, the Constitutional Party of Japan also draws most of its support from the 50's, 60's and 70's people age groups and are being trounced by Sanseito and Democratic Party of the People with younger age groups. This is a significant observation on the direction Japan is taking with resistance to too much tourism, too much migration, and not enough attention to Japan's national interests. The LDP under Ishiba is now navigating a new environment as it looks to running the government taking credit for the US Japan Trade Agreement and working with the new parties. ...

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Greg Ip of the WSJ cautions about thinking that the GDP growth of 3% is likely to be achieved with the Trump plan for a corporate tax rate of 15%. He says evidence from Britain and Canada- Britain reducing the tax rate from 30% in 2007 to 19% today, and Canada from 28% in 2000 to 21% in 2004- is disappointing. In Britain the increase in GDP averaged about 0.1% a year. Business investment increases with cut in corporate taxes, and the U.S. corporate tax rate is higher than other advanced countries such as Germany, yet GDP growth includes other factors, such as the business cycle, demographics, productivity growth, aging, technology, regulation, says Ip. It is better if the tax cuts are spread broadly over the population, and tax cuts are offset to a greater extent by savings in other areas, and that tax cuts promote productivity boosting investment, to create enough of a surge in growth above 2%.

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In EU elections the German coalition parties of SPD, Greens and FDP barely get the vote percentage of the CDU/CSU of 30%. The SPD 13.9%, Greens 11.9% and FDP 5.2%. This is the lowest showing of the SPD. Much of the problems come from the SPD socialist democratic party that seeks to bring more social democracy by building infrastructure, public services as Biden is doing in the US, yet is prevented from doing this with the presence of the FDP which is against spending and seeks budget discipline as the charter of its party. The Finance minister Lindner is from the FDP. As a result the SPD and Greens are not able to do what they prmised in the last election to invest in infrastructure and public services. A visit to Germany shows this with the Deutsche Bahn, the rail stations with a dilapidated look as if built in the last century, trains late with old technology and less investment in maintenance. Not much construction is seen and public transport looks haggard and old. Germany's constitution makes investment difficult and court decisions limit spending or finding other sources for investment, the FDP acting as a brake on spending. The far right AfD vote was upto to15%. Without investment and offering a new vision of a modern Germany even after managing the energy crisis of which some of the fault lay with the way Merkel allowed over dependence on Russian supplies of oil and gas, even then the CDU is getting more of the vote. Another reason is the CDU under Leyen taking a strong stand on Ukraine with the SPD's history of maintaining better relations with Russia limiting its role in this crisis. As a result Germany under Scholz labors on with no solution to current problems requiring spending and investment. The next parliament election is in 2025. ...

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FDA questions quality of life improvement claims for drugs known as ESA's or erythropoiesis-stimulating agents, which are the drugs Epogen and Aranesp of Amgen and procrit by J&J.

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Continued slowdown in Avandia sales. FDA experts continue to be critical of Glaxo studies on Avandia.

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Youth unemployment and forced migration plays a major role in the Nepal general election. Rapper music Balendra Shah 35 years wins in parliamentary constituency over ex-PM Oli and wins the Nepal general election. He formed the RSP party to voice student protests against PM Oli's government and corruption, which was forced to resign. His goal is to generate 1.2 million jobs and double the per capital GDP from about $1500 to $3000. Nepal reflects the general jump in aspirations of youth across the Indian region. 800,000 young voters voted for the first time.

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The CSU wins 36.4% of the vote in Bavaria and the populist Free Voters gains ground with 15.3%. Both will continue the government in Bavaria. The AfD advanced in Bavaria to 16%. The CDU wins 34.5% of the vote in Hesse, with the city of Frankfurt in Hesse. CDU will continue to form a government in Hesse. The AfD won 18% of the vote in Hesse. The FDP got less than 5% threshhold for representation and the Social Democrats went from 19% to 15% in Hesse. The economy and immigration played a part in the losses of the Social Democrats and FDP.

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Sanofi-Aventis and liver risks of its drug Ketek. And the questionable practices of Sanofi in the study assessing the liver risk that the FDA draws attention to in its letter to Sanofi-Aventis.

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The FDA in heightened concern for safety decides not to follow an advisory panel's close 7-6 vote that Doribax for hospital acquired pneumonia was efficacious, and a 8-5 vote that it was safe. The FDA is taking more time to make decisions and asking for more data. In this case it paid attention to the questions raised by some advisory panel members about the design aspects of the study used to test the drug.

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Jens Thurau writes about a holiday trip to Fohr on the Wadden Sea on north German coast from Berlin by rail, on Deutsche Bahn, July 27 2025. Thurau writes about the travails of DB, the sudden announcements that the train is headed in another direction, having to get off and catch a regional train. On the return trip the train making a stop when sheep cause rail delays on the rail line further up, the train canceled an having to take aintercity regional express to Berlin. The employees struggle too as the conductor on the return trip offers vouchers from DB to passengers and his apologies. Many DB employees having to deal with customer complaints are planning to leave.  Next trip Jens plans to drive to Fohr.  DB has suffered for years with lack of investment on the 2800 mile rail network. Thanks to chancellor Merkel who never gave priority to such investment and who Jens says called the internet "uncharted territory" in 2013, the digital part of the German economy and DB, along with infrastructure has also suffered. The Scholz coalition promised but failed to deliver on infrastructure with opposition from FDP finance minister Lindner. Only in 2025 has the new coalition of Merz with SDP has the constitutional provision limiting infrastructure spending of Merkel been removed, and DB put on the way to modernizing German rail connections starting with the Berlin Hamburg line. ...