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With Pfizer cutting back sales force, the rest of the industry may also cut back to reduce expenses and get more productivity from the sales force.

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Glaxo, like other pharmaceutical companies facing severe competition from generics, aggressively marketed the treatment for Restless Legs Syndrome (RLS) with its drug Requip. Glaxo made a strong marketing push for Requip with advertising in medical journals even before approval of Requip by the FDA, sending specialists to discuss treatment with general practitioners, and advertising strongly to consumers. Half of Requip's sales come from treatment of Parkinson's disease for which it was originally designed, the other half comes from RLS. Are their pressures to treat an expanding array of diseases merely to increase sales.

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A report by top FDA officials said that the agency's commissioner, who resigned in January, was improperly influenced by calls from Congressmen, in approving Meniflex. This is a product of RenGen Biologics Inc., a C- shaped pad device to repair injured knees. This after scientists at the agency had rejected it because it was not considered effective or safe.

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The US under president DJT puts out a new National Security Strategy in a document which states it clearly. The days of the Middle East given importance are thankfully over it says. The focus is on the First Islands, from Taiwan, Philippines to Japan for strengthening defense in relation to China. The Monroe Doctrine is now part of US foreign policy with a DJT addition- "that the American people- not foreign nations or globalist institutions- will always control our own destiny in our hemisphere."  It also means the US has a new policy towards Russia and for NATO.  The DJT administration priority, it states, is “ending the perception, and preventing the reality, of NATO as a perpetually expanding alliance.” The new strategy is that Europe needs to “take primary responsibility for its own defense.” The Monroe Doctrine and the disassociation with NATO expansion are linked. How so? Russia's foreign policy is for winning recognition as a Northern European Power with its own version of the Monroe Doctrine, being able to control its destiny in its sphere of influence. The way the Monroe Doctrine was implemented in 1823 was by a tacit recognition gained from Britain that it would support the US in its idea of no European colonial powers (France, Spain other ) being allowed to interfere in Latin America, in the western hemisphere. In 2025 the way the Monroe Doctrine is implemented with the DJT Corollary is that the US is tacitly gaining support from Russia/China for implementing the Monroe Doctrine so that no foreign powers will interfere in US sphere influence in the western hemisphere.  Where does this leave Europe and Ukraine? European Union and NATO expansion has now gone too far and NATO which was primarily for Cold War struggle between Communism and US/UK style democracies is over, but NATO has not been disbanded, or a new alliance setup with new goals. Instead as it lingers on it has created new problems such as NATO expansion to the borders of Russia, creating security risks for Russia. This has led to the war in Ukraine and the Republican administration under DJT seeks to defuse tensions and the Ukraine war by excluding NATO expansion, removing the US from European security by delegating that back to Europe (Germany and France, Italy, UK) and by acting as a moderating influence between Russia and Germany, France, that see Russia as a threat after it's attack on Ukraine. US also upholds the policy and principle of no nation invading another country, as Russia did with Ukraine, and in anticipation of the China threat to Taiwan. This part gets nuanced but the overall policy is coherent and Russia accepts this, China is gradually coming to the idea that it has to accept this situation with Taiwan to preserve its economic advances and its exports to the US and EU.  In practice once the interference of China or Russia is removed and European powers in addition, the US has freedom of action in the Western hemisphere and Latin America to prevent crises such as with drug trafficking gangs in Mexico and Venezuela, and unstable regimes sending people north to the US across the Mexican border as from Central America and Venezuela.   ...

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The French view of the DJT administration is that it is a rupture, an "historic rupture with immigration repression, aggressive trade policy, and undermining of federal and state institutions." This is far from the reality. In fact it is not a rupture, and far from that policy that DJT brought in the waning days of a tired cautious Obama administration that extended the war in Afghanistan long after it was clearly a failure from the Bush years. DJT called it common sense during his Inauguration speech waving his hands- so obvious, stay out of wars we have no purpose pursuing. Regain America's manufacturing base shipped out to China in the Clinton-Bush-Obama years 2000-2016 that helped the rise of China in phases of supply chain partner, competitor, adversary. French view Le Monde is that this is "aggressive trade policy," when in fact small towns across the US and France, and other industrialized EU nations, by losing their factory and industrial base to China have gone downhill losing jobs and standard of living. Tariffs and DJT policy was continued by Biden- there is no rupture. What French in Le Monde call "Immigration repression," is a policy of protecting border security including illegal drug and fentanyl flows and gang activity that was accepted by Biden and Biden-Republican Lankford legislation was agreed in 2024 to close the Border. There is no rupture from Biden on closing the Border.  With millions having crossed the Border illegally Republicans now have the support of Democratic Senators Gallego of Arizona and Fetterman of Pennsylvania in passing the Laken Riley Act in Congress to protect Americans and safeguard life in America.   ...

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How the new marketing approach for drug companies and Pfizer in particular is affecting how Pfizer is marketing an anti smoking drug. the approach is measure and careful and mindful of all the difficulties in making it work for patients including the psychological aspects of smoking addiction.

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British budget cuts announced in Parliament by Britain's Finance Minister, George Osborne. About 83 billion pounds in cuts by 2015 were announced. But Joseph Stiglitz, writing in The Guardian, argued that the plan was a big gamble, as declining tax revenues with lower growth, would lead to smaller deficit reductions. The gamble is that the private sector will pick up, and make up for the reduction in public outlays. If this does not happen, this risks sending the economy into a tailspin. Osborne said that 490,000 jobs will be lost over the next 4 years, some from attrition. Payments to the long term unemployed will also be cut for those who fail to seek jobs, saving $11 billion a year. A new 12 month limit will be imposed on long term jobless benefits. Increase in the retirement age will start in 2020, from 65 to 66 years. At the same time free eye tests, prescription drugs and bus passes remain. Premier Cameron promised not to make cutbacks in health care in the period before the election. This was his way of helping the Conservatives make a comeback to power....

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Criticism of the FDA's inability to exert pre-market quality control. Questions raised by a Professor of Pharmaceutical Sciences, about the FDA's inability to detect quality issues in manufacturing. After the J&J recalls for childrens Tylenol and other medicines, the FDA sent a warning letter to Perrigo, a company based in Michigan, that ships these children's medicines, about manufacturing violations. This includes ibuprofen tablets with metal shavings.

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According to the General Accountability Office inquiry, 28 drug products had price increases over 100% in 2000, in 2008 71 drug products had such large increases. Medicines like Adderall for attention deficit disorder, Inderal for chest pain, Sumycin for infections were in the list of 416 brand name drug products where makers or distributors raised prices at least once by 100% or more for period 2000-2008. As large pharmaceutical companies sold their marginally profitable drug products or small selling products to smaller companies, these smaller companies would immediately increase prices to recover the money they paid to the large pharmaceutical companies. 26 of the brand name products saw prices raised 10 fold. A third of the drugs with large price increases treat depression and disorders of the central nervous system.

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A study by AARP of 514 brand name and generic drugs between 2005 and 2009, shows that generic drug prices went down an average of 31% during this period, and brand name drug prices went up by 41%. One of the authors of the report says that it is important to look at individual drug prices and not studies showing total spending on drugs, because this is a significant cost for people paying out-of-pocket, It drives up insurance premiums, and pushes retirees into coverage gaps in Medicare Part D drug program. Analysts indicate pharmaceutical companies are increasing prices on drugs before patent expiration to get as much profit before the patents expire.

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Caterpillar Inc. CEO and Chairman, Doug Oberhelman, discussed the acquisition of ERA Mining Machinery Ltd., a maker of roof supports for coal mines, acquired in June 2012 for $700 million. The acquisition was "botched" said Oberhelman, leading to the $580 million writedown for the 4th quarter of 2012 and the 55% drop in profits. Former managers of ERA misled Caterpillar about the condition of the business, and in Obherhelman's words "fabricated documentation to cover their tracks." Caterpillar later found inaccurate inventory data and improper revenue recognition. The move to acquire ERA Machinery was an effort to increase sales of mining equipment in China, the world's largest coal producer. As in the Autonomy acquisition by H-P the diligence in checking accounting and other data failed. Caterpillar lowered its forecast for 2013 based on slower growth in mining and decline in investment by mining companies. Mining companies are seeing management turnover over overextended mining projects that went sour. Revenue for 2013 is forecast at between $60 billion and $68 billion, compared to $65.88 billion in 2012. Analysts see risks in the forecast because mining equipment orders may not accelerate till 2015. Mining equipment forms a bigger part of Caterpillar sales and sales growth than construction machinery- sales of mining equipment increased by 14% to $5.78 billion in the 4th quarter 2012, even as sales of construction machinery declined 25% to $4.03 billion. In the U.S. construction machinery sales declined 17% to $1.45 billion in the 4th quarter 2012....

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The Economist quotes experts saying that drug innovations would not be affected by price controls on drugs. Pricing reforms can accomplish the reverse, spur innovation by doing as Britain and Germany are doing- pioneering comparitive reviews of drugs effectiveness and cost-benefit analyses aimed at reimbursing firms for new drugs based on their performance. Sanford Bernstein, a financial advisory firm, says in its study that a 20% reduction in what Medicare pays for drugs would not kill off innovation, it would reduce earnings per share of big pharma firms by 3-8%. As drug research is now done in many countries, and its a globalized industry, innovation is not likely to be automatically affected by price reductions in one country like the USA, according to Alna Garber of Stanford University and Patricia Danzon of Wharton Business School.

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Increased funding for the Food and Drug Administration by the Obama administration. An additional $300 million as ben allocated. The budget request is for $2.35 billion for fiscal 2010, compared to $2.06 billion in the previous 2009 fiscal yar. Including user fees the budget request totals $3.04 billion for the 2010 fiscal year compared with $2.7 billion in the 2009 fiscal year. THe Obama administration proposes increased manufacturer user fees to pay for food-plant inspections and to speed the review of a[[lications for generic drugs and biologics drugs. Biologics drugs are derived from living organisms and are the industry's fastest growing part.

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There are serious serious flaws with the FDA regulations for weight loss pills and dietary supplements. THe law enacted in 1994 gives the FDA jurisdiction only after the pills go on the market whereas for drugs they get reviewed first. THe re is only aspot checking of manufacturers and distributors once the pills are on the dshelves or on the internet. THe FDA believes there may be hundreds of contaminated weight loss diet supplements. Says Michael Levy director of the FDA's deivision of New Drugs and Labeling Compliance, alarge percentage of these products contain dangerous undeclared ingredients. Even after the products are on the market the FDA does not have thability to remove pills from stores, initially the law allows that its upto the companies to issue arecall. It is only eventually that the FDA can act and it does not have the resources to deal with this problem. This even though these ingredients can cause heart atttacks, seizures, and all kinds of health problems. About $27 billion are spent on dietary supplement, $1.7 billion on weight loss pills, and 15% of the population say they have used weight loss supplements, and most have not told their doctors about it. ...

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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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As Washington Post writer points out from personal experience- he is one of those who put up 15% to buy ahome inDenver at the top of the market and now has negative equity as prices drop- negative equity is one of the most serious problems facing the US economy. It has the potential to undo many of the encouraging things from the stimulus, as rising foreclosures continue to act as adrag on the overall economy. As he says about one fourth of Americans with home mortgages, or about 11-15 million people, owe more money on their homes than the market value of their homes. As Hoffman says the administration's approach has been a Band-Aid at best for a serious injury. The Obama administration set aside only $75 billion to get banks to modify loans and also made this voluntary for banks to modify loans. Treasury Secretary Geithner testified in Congress: "This is a conscious choice we made, not to start with principal reduction. We thought it would be dramatically more expensive for the American taxpayer, harder to justify, create much greater risk of unfairness." But making it voluntary means very little of this $75 billion has gone to help achieve modifications- banks had no incentives to do this. Only 31,000 permanent loan modifications have been made. Of the 750,000 temporary loan modifications made as of Dec 2009 only 4% of homeowners signing up have qualified for permanent federal relief. See the links to Martin Feldstein's proposals for this on the pages of the Wall Street Journal in 2008 and 2009 which called for aggressive program of relief for the sake of the economy. With 2.4 million Americans likely to lose their homes in 2009 according to Moody's Economy.com estimates, following the 2 million in 2009 and 1.7 million in 2008, this may be a serious mistake of the Obama administration and drag out this recovery....

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Paul Krugman reviews a book by Robert Gordon, a distinguished American economist and historian, on the improving standard of living for Americans after the war in the period 1940 to 1970. This period brought some of the major changes in the standard of living which have since stalled. Gordon points to the developments in science and technology between 1870 and 1940 providing the largest boost to standards of living as the quality of life improved- especially the conditions in which people lived using modern sanitation, electricity, automobiles, and work saving appliances. The period 1940 to 1970 enabled the spread of this to the country as a whole. The IT revolution's developments occuring between 1990 and 2005 are also behind us. This process between 1870 and 1970, with the followup period to 2000, is seen by Gordon as a one time development in the scale of change and the improvement of quality of life. The future does not hold a similar level of progress in standards of living, says Gordon. Set against the current stagnation in incomes, widening inequality of opportunity, and the political discourse, this review raises important questions about the future. Quality of life potential now rests in improvements through personal involvement in health improvement, improved education, renewable sources of energy, and other ways, which are more soft knowledge improvements than the hard improvements of the past- which may require more personal involvement than in the developments of the last century of progress, with some improvement coming from renewal of the old physical infrastucture using the new technologies available. Just as the developments of the last century required dogged persisitence and effort, these developments will require dogged persistence and effort, with some of the easy stuff currently posing as technological development not qualifying....

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New code of marketing for the Drug Industry.

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Changes at USAID headed by Rajiv Shah as it makes more room for private initiative of local groups and funding of local groups in countries being helped, and shifting away from handing whole projects to U.S. government contractors. Another change is the harnessing of the efforts of U.S. corporations interested in emerging market countries for introducing their products as part of an aid effort. An example is GE for medical equipment at Nelson Mandela Children's Hospital opening in South Africa in 2016. In countries where corruption is widespread such as Afghanistan, giving money to government ministry creates risks of waste and corruption, a problem which is however part of larger problem of wasted resources in that country. The basic concept of using private initiative and getting the involvement of local groups, U.S. corporations interested in emerging markets at the aid level for their products, taken up by Shah is sound and was overdue. It is already the practice as the Bill and Melinda Gates Foundation is doing much of the heavy lifting and large scale aid effort in poor countries of Africa and Asia. Shah worked at that the Gates Foundation before USAID. An example is the Grand Challenges for Development program to get innovators to help tackle problems in poor countries- the Pratt Pouch a small pouch with anti-AIDS drugs not requiring refrigeration was developed at Duke University and could potentially prevent transmission of HIV to 400,000 babies a year. Shah's own background of immigrant parents coming from India gives him a unique insight into how to combine the involvement of the creative abilities of well intentioned Americans at universities and private companies and local groups in poor countries, to leverage the results. He has a medical degree from the University of Pennsylvania....

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Americans Harvey Alter, Charles Rice and Briton Michael Houghton win the Nobel Prize in Physiology and Medicine for the discovery of hepatitis C virus, which causes liver cancer. Before this discovery and the test for bloodborne virus giving blood transfusions was very risky as it could transmit Hepatitis C virus. Blood banks then used the test to make sure donors did not carry the virus. We now have millions of people benefit from safe blood transfusions and safe blood products. Drug makers then developed medicines for treating Hepatitis C virus. Dr. Alter worked at the U.S. National Institutes of Health in the 1970's and identified the unknown infectious agent that was not Hepatitis A or B virus. Dr. Houghton worked in the 1980's with pharma firm Chiron and isolated the genetic sequence of the then unknown virus. He now works at the University of Alberta in Canada. Dr. Rice, a researcher at Washington University in St. Louis found a component at the end of the Hepatitis C virus genome that played an important part in its ability to replicate. ...