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The FDA relaxes some of the restrictions on anemia drugs of J&J and Amgen used by cancer patients after protest letters.

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Was Merkel right in setting an amendment to the German Constitution to limit the structural budget deficit to 0.35% of GDP. It is called the Schuldenbremse Amendment. It means there is no money to invest in the country's future, no money for infrastructure even when it is old and crumbling for roads, bridges rail stations and airports, no money for digitization of the economy in which Germany has fallen behind, not enough for defense, and no money to fund needs in education, healthcare, childcare. And not enough money to invest in climate change action. Absent this investment the German economy falls behind, jobs become precarious and public dissatisfaction leads to volatile political situation. Like the Republican party in the US which calls for tax cuts and no walk the talk for infrastructure investment, the CDU/CSU and FDP, have a mindset opposing investing in Germany. Investment that the Greens and SPD promised but could not deliver with the FDP in the Scholz /Habeck /Lindner coalition over 4 years. ...

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Supreme Court nominee Kavanuagh has shown a pro-business tilt on many issues. On net neutrality he favored telecom and IT companies. On a ruling on the Consumer Protection Bureau he empowered the president to fire the director on the legal reasoning that there should be several commissioners running the agency. The Net Neutrality ruling from the Obama years was overturned by president Trump, the Consumer Protection Bureau continues to have a Director. On other issues such as Clean Air Act he overturned a ruling. He also defended the rights of pharmaceutical companies vs. the FDA.

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DFA's David Booth runs paasive investing funds with assets of $800 billion. He asked Errol Morris to do this documentary on passive investing called "Tune Out the Noise," offered now free on You Tube for 1 month. It shows the idea of passive investing inthe market by investing in a basket of stocks covering and representing the whole US economy.

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The McNeil unit of J&J has made serious errors in its response to FDA's warning letter of of consumer complaints about its Tylenol arthritis caplets. Reminscent of the recent problems at Toyota which like J&J had been a leader in product safety and quality, J&J has mismanaged the FDA complaint. In January the FDA sent a warning leter to McNeil that it had failed to investigate properly consumer complaints made since 2008 of a musty odor from the bottles of Tylenol Arthritis caplets. The source of the problem lies in failure of quality control in its manufacturing facilities. McNeil is now conducting a comprehensive review of its quality management systems. McNeil has identified the cause of the smell as the breakdown of a preservative, used to treat wooden transport pallets, that had leached into the products at a company plant in Las Piedra, Puerto Rico.

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Can a company encourage doctors to prescribe a drug for conditions other than what it is approved for by the FDA. Lilly settles with federal prosecutors that it broke fedral laws on marketing drugs and agrees to settlement of $1 billion. About $4 billion of Zyprexa prescriptions are sold each year.

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The memorial to Franklin Delano Roosevelt (FDR) by the American architect Louis Kahn takes shape on Roosevelt Island after a 30 year effort. It sits at the southern end of Roosevelt Island right across the river from the United Nations Plaza. The memorial will open in October 2012. The project cost $53 million with the work starting in October 2010. For years the project lacked funding. The memorial has five parts, an entry, triangular garden, forecourt area, a sculpture court and the "Room" which provides a meditation place for reflecting on Roosevelt's legacy and the Four Freedoms of speech, worship, want and fear.

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600,000 knee replacement surgeries a year in the US and 30 million suffering from osteoarthritis. The Wash. Post looks at new options which include use of coral that can repair the cartilage in a knee. The coral is part of Agili-C approved by US FDA and developed by CartiHeal. It is made from a calcium carbonate that is derived from exoskeletons of coral that act as a scaffold in the body to help regenerate bone and tissue, says the Washington Post in this article.

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An indication of how much controversy is becoming part of the drug risk appraisal process, involving the medical journals, the FDA, the Congress, the drug companies, the courts, and independent physicians, and the users of the drugs, with charges thrown back and forth. The information on Avandia comes from Merck's own website and was an attempt to provide more public disclosure of drug studies conducted by the manufacturer.

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Mr. Lindner of the FDP withdraws from negotiations leading to a stalling in the talks for a Jamaica coalition in Germany. FDP won 11% of the vote, the CDU about 32%, and the Greens 9% in the recent election. The CDU needs the FDP to form a coalition government as the Social Democrats have turned down requests to join the CDU in a future government. The SPD party sees no advantages in joining a coalition because it lost more of its worker base support by working with the CDU. If no coalition is formed a new election could be called by September 2018.

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Serious issues with China's export of drug and food related items. The same is true for the domestic use of drugs and food which has been contaminated by hazardous chemicals. Zheng eas head of China's FDA from 1998 to 2005. China is reviewing some 170,000 production licenses issued during this period.

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The Times reports that multiple red flags were ignored at the Financial Conduct Authority as the 237 million pound London Capital and FInance scandal developed. Mr. Andrew Bailey headed the FCA during the period of the scandal. He is now the Governor of the Bank of England. 

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Share of US Counties where 95% of Kindergarteners are vaccinated against Measles drops to 28% from 50% in Washington Post Investigation of 44 states December 2025. 95% vaccination rate is what experts say is needed for "herd immunity" or overall protection in a class. Washington Post examination of data shows marked deterioration from 2018-2019 school year to 2024-2025 school year data and public records. That is 5.3 million children are exposed from lack of herd immunity from measles now compared to 3.5 million children earlier increase of 1.8 million children. This Wash. Post investigation shows 19,000 schools are exposed and one can go to this article to find on a map how your school district and country are doing in the 44 states. A big problem is emerging from public skepticism and politics in vaccination. For generations schools required vaccination proof- by 1980 all 50 states had laws covering students first entering school. And caught in vaccine politics legislatures are creating religious and other exemptions that have weakened laws. Wash. Post says it's examination shows not a single County in Idaho, Louisiana, Oregon Tennessee, Utah, and Wisconsin meet the 50% vaccinated requirement for measles required for herd immunity. This could mean more of these diseases will be brought back home including whooping cough to affect elderly and infants. Democratic districts such as in St Louis and Chicago also see drop in measles vaccination rates. In the sense that newly decolonized countries since 1950 such as China and India have emerged with good health systems and mandated vaccination , other public health action, there is a great need for the US to focus on bringing back the public awareness that existed after the 1940's in the US that resulted in significant advances in public health in the US in the FDR, Eisenhower, Kennedy, LBJ and Reagan administrations. It shows there is no victory in public health. A lot of work needs to be done, as much of the gains can get undone by events and public awareness is necessary. As pharmaceuticals, chemicals and plastics and bad nutritional habits took over American lives there is an effort under Kennedy at HHS to tackle that health crisis, but it brings with it challenges that date from the pandemic and different responses in different parts of the US to mandatory vaccination which also have to be met through education not social media. ...

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Warning labels for the diabetes drug Avandia and a great deal of agreement that Avandia does pose some higher risks for the heart is how the FDA concluded its vote and discussion on what to do about Avandia for the safety of users.

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Kate Conger NYT looks at working for Google in 2007 vs 2025 how tech or software jobs are not exciting anymore. Many of the so called Tech companies -as technology and science is the very basis of life since the year 1700 in UK, Europe and the US and today's "Tech" is a misnomer in that context- have become huge bureaucratic, and unresponsive. Computer coding is not the profession it once was, not even in India as Indian reports show it has also lost it's glamour there. This kind of "Tech" of Google, Apple, and social media was always a cultural fad that made things look cool so that the highest profit margins could be made and justified, ignoring the essential facts about science and technology over 300 years 1700-2000 in the UK, Europe and the US. Since the early scientific observation in the 18th century in UK and Europe science has underpinned our lives, and with the industrial revolution and machines it has covered every aspect of our lives with new inventions and scientists into the 19th, 20th and 21st century. As a cultural fad of the Google /Apple kind it came on the back of the largest deindustrializing of US and Europe in the late 20th and 21st century, and ignored the fact that science and technological application is part of everyday life, the very meaning of the word modern that Japan, China and India has aspired to, to copy the Europeans and Americans, not the prerogative of any corporation.   ...

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The Free Democrats led by Christian Lindner are polling about 4% a week before the elections in Germany. Lindner's FDP was part of the Scholz SPD Greens coalition after winning 11% of the vote in 2021. Elections would be held in 2025 March. Yet with FDP breaking away from the coalition as its popularity dropped elections will be held next week. From the beginning this coalition was not a good one as FDP supported the debt brake and no spending, when Greens and SPD promised investment in infrastructure that were neglected by Merkel's CDU. Germany economy as shown in the article alongside by Tankersely and Eddy reporting from Wittenberg in the eastern region, has not grown in 5 years. Crumbling infrastructure is seen everywhere in cities across the country and the rail system lacks much needed investment.  Scholz wants to reverse this with Made in Germany and remove the debt brake. The CDU wants to cut taxes and regulation. No one knows if the FDP will pass 5% of the vote needed to have representation in parliament. It happened before for FDP- before the 2021 election. ...

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Japanese drug company Astellas makes a $1.1 billion hostile tender offer for California based CV Therapeutics. CV Therapeutics makes an angina drug that recently received FDA approval to isgnificantly ease safety warnings that have been placed on the drug. Astellas is the second Japanese company looking to bolster its drug product line by making an overseas acquisition. Takeda Pharmaceutical acquired Millenium Pharmaceutical for $8.8 billion in 2008.