LyrArc Article Gist
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. ...

LyrArc Article Gist
The expansion plans of VW will add more competition into the US market which is declining. Martin Winterkorn ran VW's Audi business. He became VW's new CEO this year and brings a new leadership perspective to his job. He has several new strategies. In the area of pricing he wants to reduce unneeded features such as external mirrors that fold inward for narrow European streets, and bring down the price of VW Jetta and Passat models to be competitive with Toyota's Corolla and Camry models. Currently a Jetta is $17,000, a Corolla is $ 15,200 and a Passat is $23900 compared to a Camry at $20,000. VW's plans are to set a sales target of 1 million cars by 2018, tripling sales in ten years from the current 330,000 vehicles. In the next 3 years to 2010 sales world wide are expected to increase by 12 to 15%, VW wants to capture a bigger share by seeing its sales increase by 30% from the six million units today to 8 million units by 2010. Winterkorn sees this as possible given that VW has a more centralized management structure now which makes for quicker decisions. VW is also working on a new family of small fuel efficient cars on a common platform to be sold in China, India and other markets where a small car will be popular. Winterkorn referred to its new concept car as an example of the direction this would take. As importing cars from Europe is becoming costlier with the strong euro and the Japanese in contrast have the advantage of a weaker yen, the expansion plans will require lower pricing. VW looks to build a plant in the USA. Another strategy is to add 12 new models to its global product line and to launch more new vehicles in new product segments. This is what Winterkorn thinks has given Toyota its increased sales. A new compact SUV caled the Tiguan will be introduced. What all this means is that VW is seeking to move buyers of Japanese and American cars to try German cars, make German cars cost less and make a strong showing in the American and global markets. ...

LyrArc Article Gist
Spiegel Online provides a inside look at the leader of the Law and Justice Party which was elected to power in 2015. The liberal opposition that was in power since the fall of communism has seen its popularity decline in the rural areas of Poland, especially in the east. The urban-rural divide seen in other countries such as France is acutely present in Poland and other parts of Eastern Europe, with poor governance and a tendency for economic gains made under capitalism following the fall of communism to go to more educated people in the large cities. The party's leaders are Lech and Jaroslav Kaczynski who were president and prime minister from 2005 to 2007. At the time they were seen as outsiders lacking the sophistication and experience in government of the liberal opposition under Donald Tusk, who now is head of the EU Council since 2014. Tusk was prime minister of Poland from 2007 to 2014. Lech Kaczynski was killed in a plane crash in 2010. Jaroslav Kaczynski appoints members of his party to key positions in government including prime minister Duda. Kaczynski is strident about the manner in which the gains since Poland joined the European Union have gone only to certain groups able to benefit from capitalism. At a recent party congress near Warsaw he is quoted here as saying: "We are here to ensure that everyone in Poland has the same opportunities, regardless of where they live, in the cities or the country." Kaczynski's appeal is in offering a generous welfare state for the middle classes- small businessmen in villages and towns across Poland, common people, with subsidies to tackle the cost of living. His focus is on the "pathological" consequences of economic liberalism after the fall of the Iron Curtain, privatization that benefitted a few, including Kaczynski says former communists and dissidents. Small businessmen felt the inroads of large private retail chains, and families felt the problems of lack of investment in schools and kindergartens. The liberal opposition can only offer the hope that being a reliable EU ally will ensure prosperity, which does not go well with the eastern part of Poland. As a result the Kaczynski government is moving away from the ideas that anchor the European Union. It sees the rule of law and independence of the judiciary as something that can be changed to where the president appoints members of the Supreme Court and the judiciary. Protests in Warsaw and the large cities are taking place against these moves. Der Spiegel says this could end up the way it happened in Britain where it simply stumbled into leaving the EU just by accident. This is the situation in 2017. It could be a temporary process that is a response to the excesses of capitalism. As Kaczynski says to create a level playing field for all parts of Polish society by smoothing out some of the harsh effects of rampant capitalism. Or as Spiegel Online points out a shaky period in which the EU and Poland are at odds- ironically with Donald Tusk as the head of the EU confronting both Theresa May and Kaczynski.  ...

LyrArc Article Gist
Adly Mansour, Chief Justice of Egypt's Supreme Constitutional Court is sworn in as interim president in July 2013, after the ouster of president Morsi.

LyrArc Article Gist
Douthat of the NYT describes the criticism of the U.S. and Canada for taking so few refugees from Syria, and responds by saying chancellor Merkel may have taken on greater challenges of assimilation of a new wave of Arab migrants than Germany can handle.

LyrArc Article Gist
How one war widow is coping with the death of a husband in the war in Afghanistan. Lisa Hallett in Puget Sound with three small kids has kept alive her husbands memory as she makes a 26 mile run through the streets near Puget Sound, Washington.

LyrArc Article Gist
The U.S. commander in Europe, Lt. Gen. Ben Hodges, says Russia respects strength, and the U.S. must add capability in this situation where Russia is no longer a partner with the U.S. and Europe as it appeared to be previously. He sees the U.S. as ready to meet all its commitments and protecting democracy. He also says Twitter is not the best way to communicate policy as president Trump does, and that he receives his instructions through the chain of command.

LyrArc Article Gist
This report by Juan Montes in the WSJ shows how much Lopez Obrador has changed since he lost by a small margin in the 2006 Mexico presidential election. His campaign manager, Tatiana Clouthier, says broadening his appeal to women, evangelicals, middle class Mexicans, rich and poor, is needed for Obrador to win in 2018. In elections in 2006 and 2012 Obrador continued to be seen as the candidate only of the working class. An effort is being made to change this image. Obrador, 64 years old from the party of the left, formed his own party in 2010 after leaving the PRD party. He is a former mayor of Mexico City. Five recent polls show Obrador leading by an average of 7.5 points over Ricardo Analya, the PAN candidate for president which now has the support of the PRD. PAN on the right and PRD on the left are other opposition parties. PAN party formed the government under Felipe Calderon before the current PRI president Nieto now tainted by corruption scandals became president in 2012. If he were to win Obrador would change the way Mexico was governed for 5 decades. His first step would be to review the 91 exploration contracts given by the government under the Nieto administration to check for signs of graft. Corruption is a key platform of the parties running against the current government of president Nieto, for both Obrador and the PAN/PRD alliance candidate Anaya. Obrador says he would keep balanced budget deficits and respect the central bank's autonomy. The shift would be from the current export model that Mexico has supported for 35 years, to one based on import substitution policies, higher salaries, and more government spending for education, jobs programs, healthcare, new oil refineries. With the Trump administration's stance on trade and immigration Mexicans are now showing anger and frustration, with 75% of Mexicans in a Reforma poll looking for change. Both the PAN/PRD and its new face in Ricardo Analya, 38 years old, and the Obrador party see corruption and with it in the Mexican context the rule of law as a key issue.  ...

LyrArc Article Gist
Eric Cantor, a House member from the Richmond area, who is the face behind the zero Republican votes in the House for the Stimulus Plan. He says Democrats should not take the message from this that they should not mess with the Republicans anymore in discussing the plans for the economy. Is this good policy though, when the bill has given some middle ground between tax cuts and spending, and the spending is on areas neglected for years such as roads and bridges, classrooms and energy infrastructure? And is there an element of lack of comprehension by Republicans stuck on ideological grounds, of the seriously deteriorating nature of this crisis which is likely not to come back with recovery in several years, and is a global crisis? When Prime Minister Thatcher, UK Prime Minister, left office, the British infrastructure rail, rapid transit, hospitals and schools, had been neglected for many years and voters were looking for ways to rebuild the dilapidated infrastructure. The economy was weakening under her Conservative party successor, giving the Labor Party its chance to make a come back on the grounds of rebuilding infrastructure and services, and improving the economy. In which case there are just as many risks in this approach of being left out entirely and losing credibility across the country. Sometimes a feel good position may not be the best, or the wisest option, and may be shortsighted. ...