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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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Dr. Wolfe, a drug safety critic and head of the health group of Public Citizen, a Ralph Nader founded consumer advocacy organization, has been appointed to a four year term on the FDA's Drug Safety and Risk Management Committee. Dr Wolfe's has a history as a consumer advocate for health safety and a critic of the corporate influence in FDA decisions. He would like to see fewer copycats of popular drugs and limits on direct to consumer advertising. Here Dr Wolfe's personal style as an activist is explored. He admits he tends to have firm opinions.

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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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Abbott Laboratories agreement to pay $1.6 billion in civil and criminal fines for promoting unapproved off label uses of the neurologic drug Depakote, to sedate older patients in nursing homes. The acting associate attorney general, Tony West, said: "Not only did Abbott engage in off-label promotion, it targeted elderly dementia patients and down played the risks apparent from its own clinical studies." Abbott aggressively promoted its use in nursing homes. It also aggressively promoted the use of the drug for schizophrenia between 2001 and 2006. In 1999 Abbott had to discontinue a clinical trial testing Depakote's effectiveness against dementia after results showed increased incidence of anorexia, drowsiness and dehydration.

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The restructuring underway at Pfizer. Experts view the cut in R&D budgets, when more new drugs are needed, with skepticism. Pfizer and other drug manufacturers believe they can make up for this by working closer with universities. Pfizer is reducing the size of its Groton, Connecticut R&D facility and is moving research operations closer to universities in Boston and Cambridge, England. R&D budgets will be cut 30%, from $9.4 billon to $6.5- $7 billion. The emphasis now is to develop a new model for drug development by focussing on a few promising areas, collaborate closely with universities, and fill gaps with acquisitions, as a more efficient way to develop new drugs. In this new approach the infant nutrition business, even with its high growth rates, did not fit in. Cash from the operations sold to Nestle will be used to make share buybacks and be returned to shareholders. Other drug companies from Novartis to Bristol Myers are trying this approach.

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The difficulties in making profits from generic drugs because of intensifiying competition among the generic drug makers.

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On April 20, 1996 the story of the merger of Ciba Geigy with Sandoz was the first story in notes made that day for Lyrarc from the WSJ Europe. This was during a trip to Europe. Ciba Geigy and Sandoz had become part of the home medical kits in Asia and Latin America by the 1960's, and their story had to be told to millions of people in these countries bringing Basel, Switzerland, to the world. Sandoz was founded in Basel in 1886 as a chemical company in Basel, Switzerland, and entered pharmaceuticals business in 1900. Ciba Geigy was formed in the 1850's as a chemical company for dyeing silk fabrics and entered the pharmaceuticals business in 1930's. The two companies were merged in December 1996 to form Novartis. Today Sandoz is the generics manufacturing part of Novartis. As prices of generics have declined Novartis CEO Narasimhan is planning to sell or spinoff Sandoz. With this move Novartis will focus solely on innovative drugs, says this report in WSJ. CEO's have also shifted fin the 25 years since the merger of Ciba Geigy and Sandoz from one with family connections to one with a professional background from India.   ...

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China's new prime minister Li Keqiang makes his first foreign trip with a trade delegation for talks with Indian representatives and business leaders, showing the importance he places on India. India offers China's companies access to large opportunties in infrastructure development, and China can benefit from India in the area of information technology and pharmaceuticals. Trade is envisioned as expanding from $70 billion in 2012 to $100 billion by 2015, and expanding rapidly as the two economies grow. Economic contacts also would provide an anchor for future relations as China faces difficulties in its relations with Japan, and S. E. Asian countries, and a U.S. wary of China's capabilities. This was pointed out in the joint statement. Li Keqiang also emphasized this in an editorial page article in India's daily newspaper, the Hindu, saying India and China have "to work hand in hand," to promote Asia as "an anchor for world peace." A peaceful India-China trade and economic relationship opens the way for investment and participation in development by China alongside Japan, Germany, France, UK and the U.S. in India, as the next major source for global economic growth. This also serves to defuse Asian tensions as both economies grow, and increased contacts between cities in India and China with the twining of cities program launched in the meetings. India can use China's capabilities in infrastructure development, the two countries share the need for information sharing on lowcost solutions in healthcare, in managing urbanization, and solutions for clean water in rural areas, and use of IT solutions in development, where much remains to be accomplished through cooperation. Some of these themes are the focus of Li Keqiang in his efforts for urbanization in China. ...

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Reinvented drugs, by combining drugs that have lost patent protection with some other ingredient to make product extensions, accounts for 27% of Glaxo's sales growth over the last 7 years. Critics point to this as a lack of innovation in its labs. Example of this is Treximet for migraines that combines older drug Imitrex with a painkiller ingredient. Glaxo has lost 28% of its share value on the London Stock Exchange.

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CEO Ryan at CVS/Caremark. An unassuming man with a sharp focus on things, joined CVS right out of pharmacy school at University of Rhode Island. At 29, CVS owner Stan Goldstein gave him the chance to run pharmacy operations for CVS, then a regional drugstore chain in the eastern USA. Over the years CVS has made a number of successful acquisitions, the latest being the acquisition of Longs Drug store chain on the west coast, and it is now one of the largest chains in the USA. It has nearly 7000 stores and more than 50 million users of its CVS loyalty card in the US. As the pharmaceutical business evolved pharmacy benefit management (PBM's) companies like Caremark, Medco, and Express Scripts, came into being to manage burgeoning prescription costs. PBM's work with companies to save money, by filling recurring prescriptionsin 90 day quantities through the mail at reduced per pill cost. Now drug store chains instead of competing with PBM's are either creating or acquiring these larger PBM's. THe result is that a company like CVS which acquired PBM Caremark in 2007 for $27 billion, now has extensive computerized databases with patients information and drug usage histories. Ryan's clear focus is on these IT records as a distinct advantage, if he can use it to help the Obama administration's efforts to control health costs of chronic diseases like diabetes and arthritis, and back or neck pain, high blood pressure, and others, that end up clogging the hospital system and raising health care costs. By using these IT records to flag when a patient is not compliant or taking his medications and call the patient, Ryan can increase drug sales, get more visits into drugstores if the drugs can also be picked up at CVS stores, and increase sales through ancillary purchases during visits. This is now his strategy. It also includes setting up more clinics at stores and at corporate locations that divert the patient flow for small care like sore throats, flu and the like. As this is the way health care costs can be controlled, Ryan sees himself as helping achieve national goals while keeping CVS in the sales and profit picture for the US, even as health care as we know it goes through a complete transformation that removes the waste and unnecessary cost, and improves effectiveness and health. He sees CVS/Caremark right where it wants to be with its large patient drug database from about 1 billion prescriptions it fills each year, and as the largest single buyer and dispenser of prescription drugs in the country. ...

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John Cochrane, professor at the Booth School of Business, University of Chicago points to the simple truths about U.S. healthcare- out of control pricing because of the pathologies created by previous laws and regulations. He points out that costs are high in healthcare because regulations keep them high. Supply of new doctors is controlled because Congress and the AMA made it that way with a cap on residency programs and AMA opposing the expansion of medical schools. In a system of open competition new hospitals and health care businesses would challenge old ones which is not happening in a regulated market with regulations working to limit competition for the firms already in the business and with the influence to limit competition. Insurance costs for major expenses in an open and deregulated competitive market without the regulations would be so much lower than todays costs that its likely we would not even need a mandate such as the one the Obama healthcare law imposes.

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Should Arthur Levinson and some of the team he has assembled at Genentech leave it will be a big loss for Roche, as it was his team that helped bring a series of new drugs to the market such as Avastin, Herceptin, and Rituxan to bring Genentech sales from $1 billion in 1999 to $9 billion in 2007. As drug companies buy biotechs in large numbers, with $70 billion in deals this year almost twice the toal for 2007, the question remains whether the drug companies have succeeded in retaining talent as consolidation yields cost savings but does not improve drug discovery. Drug companies are struggling with this, and a couple of models have emerged for keeping minds engaged in scientific discovery satisfied that they have the freedom to operate as they always have and work with the teams they have assembled, similiar to the work style and in the similiar culture as before. Almost like walking into the offices they use as if its like before. J&J has come up with a hub and spoke model to acquire companies and then leave them alone- preserving their management teams, unique cultures and brands. Centocor was bought in 1999 by J&J and 10 of the top executives stayed on and developed Remicade, a drug for inflammatory disease that has sales of $3.3 billion. Glaxo has developed a new structure under new CEO Andrew Witty, which breaks up the primary research labs into "discovery performance units" or DPUs, which also include new biotech startups. In April Glaxo acquired Sitris, a Cambridge, Massachusetts startup. The company had come up with a new science for tackling heart disease, diabetes and other diseases associated with aging. Harvard trained scientist and CEO, Christoph Westphal, went with Glaxo turning down other companies because the independence of the DPU appealed to him. Each DPU has a 3 year budget and this also appealed to Westphal. He could walk into the labs, says Westphal as if nothing had changed. Is Roche making a mistake in acquiring Genentech when it could have left it alone. Are the consolidation savings worth it if some of the discovery team at Genentech leaves and there is the feeling that the culture will change, and if Levinson feels that he was not consulted about Roche's move. These are questions that remain even when Roche's CEO, Severin, says he does not want to change things at Genentech because Roche's actions will speak louder than its words. ...

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In the Senate Obama backed bills favoring importation of drugs,of cheaper prescription medicine from Canada and other countries. But with the pharmaceutical industry and its lobbying groups contributing heavily in federal elections and its clout with the administration Obama turned his back on the bill. This happens as Americans are paying as much as ten times the prices Canadians and Europeans are paying for drugs and prescription medicne for identical medicine often produced in similiar facilities aby the same manufacturers. On this issue an impressive coaltition was assembled among bothe Democrats from Bernie Sanders of Vermont to Senator McCain of Arizona, but the bill introduced by Senaor Dorgan was defeated with the help of the Obama administration. Senators from states with big presence of drug manufacturers like New Jersey (Menendez), New Jersey (Lautenberg), Delaware (Carper), North Carolina (Kay Hagan) all argued to defeat the bill to allow importation of drugs to help the heavily burdened American public. The Obama adminsitration's FDA Commisssioner Margaret Hamburg issued a statement expressing concern about the "safety" of imported drugs....

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Under a new program to increased spending on healthcare from 1.3% of GDP to 2.5% the Indian government plans to provide free pharmaceuticals at state run hospitals. This is expected to cost $5 billion over 5 years. Initially 350 drugs would be on a list of essential medicines and would be purchased from generics manufacturers in India. Dr. K. Srinath Reddy, heads the committee advising the Indian government on healthcare. He says this will help improve access to medicines for the vast majority of the people. Estimates show 70% of out of pocket medical costs for Indians come from spending on drugs. About 40 million people are pushed into poverty each year because of the high cost of medicines, says Dr. Reddy. He said that in 1984 31% of the medicines at government run hospitals were provided free to admitted patients, dropping to 9% in 2004. For outpatients this dropped from 18% to 5%. The free medicine program would be part of a larger universal health care program to be introduced over the next decade. India's large generics pharmaceutical industry makes the provision of free medicines on a large scale a feasible option in India because of the lower prices, with additional pricing advantages when purchased in larger volumes by the government. This would also have a major impact on the quality of healthcare in the country of 1.2 billion people for a relatively small investment. It also promotes a sense of fairness and equal access because the benefits of decades of modernization have been unevenly distributed and because of widespread poverty....

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A sense of how the U.S. Supreme Court Justices viewed key aspects of the Obama Health Care Law after three days of hearings on March 28, 2012.