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Areas for growth for the Indian drug Industry include the large growing domestic market, the outsourcing by US drug manufacturers, and sales in other developing countries of Asia, Middle East, Latin America and Africa. Analyst estimates are that India will spend $30 billion a year on drugs to improve care for its people in the next 10 years up from $8 billion today. And the distribution network is being developed by drug companies insdie India to reach more people. Also companies like Pfizer plan to double outsourcing of manufacturing drugs from 10% today to 20%.

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The Supreme Court's ruling against Wyeth knocks down a 2006 Bush administration regulation which declared that permitting product-liability law suits conflicted with "FDA's role "as the expert federal agency responsible for evaluating and regulating drugs." Justice Paul Stevens writing the majority opinion said the Bush position is "entitled to no weight, and was "inherently suspect because no evidence was given in support of its position and the states and the public did not get an opportunity to comment before it was issued. Wyeth had argued that it met FDA guidelines in the label for its antinausea drug Phenergan, and wasn't liable when a 63 year old guitar player lost her arm after receiving the drug.

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Questions raised about Dr Pazdur's decisions at FDA for anemia drugs made by Amgen and Johnson and Johnson. Dr Pazdur is head of the FDA office that regulates oncology drugs, all cancer drugs. Dr Pazdur's review process and decision shows how reviewers are human and their own experience helps determine what they see prominently. His experience with his father who suffered severely from the side effects of steroid drugs would make him aware of the the other effects of drugs. He is an oncologist, his wife is an oncology nurse, and some relatives have died of cancer, so he has lived with cancer patients. It appears from close associates that he like open communication and hears all sides but makes the final decision himself. He had an experience with a drug for lung cancer Iressa made by Astra -Zeneca, which the FDA approved based on testimonials, but not enough statistical evidence, which later failed and approval had to be withdrawn. This may have made him more inclined to look for strong results and statistical evidence before concluding on the safety and effectivenes of a drug. An approach evident with Amgen's anemia drug. It also appears that the FDA is not clear on whether the drug's effectiveness is to be judged by what result, is it whether it prolongs life only that counts, or whether the effectiveness in relieving significantly the symptoms of a patient even if life is not prolonged. There is the controversy surrounding the FDA's rejection of a drug by Genta Inc Genasense that relieved patient symptoms for leukemia but did not prolong their life. These and other questions continue to give sleepless nights to people at the FDA and outside as the drug review process faces difficult balancing act between what to give importance and what direction to take with a drug in patient's interests. In Dr Pazdur's case this is made more difficult as he thinks every day of his father who died in 1979 and suffered from the side effects of steroid drugs, went blind when Dr Pazdur was only a teen, and had pulmonary fibrosis and diabetes. He is described by doctors who trained under him as gentle but did meet a patient's eyes and tell him that he had to come to terms with his disease. ...

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The FDA sets a pathway for developing "biosimilar" drugs in the U.S. Biosimilar drugs are cheaper versions of higher cost biotech drugs. Europe has moved further ahead in this area.

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Are high prices for pharmaceutical products and healthcare services putting a severe burden on U.S. finances and defunding education, infrastructure, R&D in new technologies, which provide the underpinnings for future U.S. competitiveness? Yes say experts. In 2009 Americans per person cost of healthcare was $7,960. By comparison Canada was $4,808, Germany $4,218, and France $3,978. And without necessary efforts for educating people about caring for health and preventive care, the health conditions of Americans are no better than these countries, and poorer in some dimensions. Klein says deficits would not be a problem for the U.S. if prices for pharmaceutical products and healthcare services in the U.S. were similiar to that of the largest developing countries. Experts say the Obama healthcare law simply postponed the addressing of this problem.

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A shift in priorities away from focussing on high growth to lower sustainable growth was announced by China's premier Wen Jiabao at the National People's Congress, China's parliament, in March 2012. This shift will reduce investment in infrastructure, power generation and exports, which will affect the level of imports of commodities from commodity producing nations in the Middle East, Australia, Canada and Brazil. It should increase imports of software, computers, entertainment, tourism and high tech goods from the U.S. and Europe. Chinese leaders have said they would make this kind of shift for some years now but growth has consistently increased more than the target rate, and domestic consumption as a percentage of the economy has actually decreased in the last decade. Now 9-10% growth rates may be a thing of the past and the target of 7.5% set this year may be actually closer to the real figure. The Chinese leaders have belatedly realized the need to make these changes now because slowing markets in Europe -which is seeing declining growth and high unemployment- and in the U.S., make the issue impossible to avoid. Wen told the Congress: "Accelerating the transformation of the pattern of economc development... is both a long term task and our most pressing task at present... Domestically it has become more urgent but also more difficult... to alleviate the problem of unbalanced, uncoordinated and unsustainable development." This is his way of saying that its unavoidable and better to start in earnest now, and at the same time recognizing the resistance to change from the stateowned companies and the other interests who have benefitted from surging growth, and now occupy a central role in the power structure. An opinion article in the People's Daily, China's official newspaper, said: "imperfect reforms are to be preferred to a crisis caused by no reforms." The World Bank's president Zoellick is respected by the Chinese leaders. He also urged them to make changes now. The recent report of the DRC, China's planning research arm, and the World Bank, also laid out the new direction away from a focus on infrastructure to domestic consumption. The fear is sudden deceleration in the absence of policy action. The impact of this will be negative for commodities over time, leading to slower growth in Australia, Brazil, and Canada. It should boost imports from Europe and the U.S. of high tech, consumer, pharmaceutical goods over time....

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The shift to finding new drugs for cancer. Pfizer has a development team of 10000 researchers in one location near San Diego, California, to develop new drugs for cancer even though some experts say the search for cancer drugs is devilishly complicated. The causes of cancer at the molecular level are complicated and vary even from person to person for the same cancer. Says one expert this also raises questions about the benefit to people as a large amount of resources are shifted to areas like cancer that affect fewer people than other diseases, and where the existing drugs have only prolonged life marginally, in some cases even as low as a few months at a huge cost of thousands of dollars. Tarceva for pancreatic cancer for example only prolongs life by 12 days at a cost of $3500 per month. 860 cancer drugs are being tested in clinical trials according to the trade group of the pharmaceutical industry. This is more than twice the number for heart disease and stroke, and nearly twice the number for AIDS and all other infdectious diseases combined, and nearly twice the number for Alzheimier's and all neurological dieases combined....

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How the discount drug programs at the big drug store retail chains like CVS. Walgreens and Walmart are leading to increasing competition and lower prices in generic drugs that are now sold for one month supplies for hundreds of unbranded drugs. Mass mechandisers like Target have their own programs selling drugs in the same manner as the Walmart which started this with its $4 generic prescriptions for one month supplies in 2006. Its changing the landscape for drug pricing gradually and will become part of a larger trend as health care costs are challenged in different ways by customers, merchandisers, and others in a low inflation cost conscious economic environment, with an overstretched indebted consumer looking for ways to cut costs on everything from groceries, shopping needs and prescription drugs.

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Smaller biotech firms typically have products in the development stage and are not making money. Now they are facing increasing financial hardship. Even in good times except for a few names like Genentech and Amgen, the others are struggling. They have a hard time raising money, and its coming at a higher price, 90% of equity instead of 50% like before for 5 or 10 or 20 million dollars. Older shareholders are diluted with new capital raised. And some are selling out. Others are going into bankruptcy liquidation, after wrenching periods of firing most of the staff. Even blue chip firms like Helicos of Cambridge, Massachusetts, which went public in 2007, and has backing of advisors like Steven Chu, the Nobel Prize laureate, are in trouble; with its DNA reader designed to produce custom tailored cancer treatments at $1 million a piece. It has not booked a sale, faces competition from a reader developed by two companies, Roche and Illumina of San Diego. It almost ran out of cash last year. Helicos shares $18 last year, are at 54 cents. According to Burrill and Company, a venture capital concern, 100 of the publicly traded biotechs this year may be lost as companies fail or get taken over. 120 of the 360 publicly traded biotechs have less than 6 months cash left, compared with 12 a year ago, says Burrill. Already 10 have declared bankruptcy according to Biotechnology Industry Organization. BIO is asking Congress to step in and for the government through the National Institutes of Health to provide matches for private investment in small startups with promising treatments. All this is happening as companies are spending large sums for mergers like the Pfizer Wyeth merger. ...

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The failure of the 117th Congress to pass key parts of president Biden's agenda for hard hit families and workers in America is now taking place. The 50-50 standoff in the US Senate and failure of two Democrat senators Sinema of Arizona, Manchin of West Virgina to support Biden's Families and Workers Plan leaves key parts of the safety net being left out. This leaves out the education, and paid leave part of the agenda and provisions for utilities to accelerate shift away from coal out of the bill. It fails to implement a new national agenda for upward mobility, child care and paid leave to help stressed out mothers and families. The failure to include even a modest community college 2 years of support at a time when men's college enrollment is dropping to disastrous levels for America's economic competitiveness is a failure of the 117th Congress to grasp the needs of families and workers in America today. Only a new Congress in 2022 can take up the needed action for families and workers in education, health care, child care and help for families. The passage of the infrastructure bill and the current version of the social spending bill can only be seen as a first step in the right direction, after three decades of different administrations neglecting infrastructure, education, healthcare, childcare, elderly care, upward mobility, and climate change. On the plus side as the first step to restore dignity and health of families and workers in America it includes- $150 billion for rental assistance, home buying help, public housing repairs, and building 1 million affordable housing units. $150 billion for federal programs for home health care and community care for older Americans and people with disabilities $165 billion to reduce premiums for people under Affordable Health Care Act, cover additional 4 million through Medicaid, adding hearing coverage but not dental or vision to Medicare. $200 billion for child care tax credit to parents. $400 billion to reduce health care costs and give universal pre-kindergarden for 3-4 year old children. $40 billion for worker training $555 billion for fighting climate change including through tax incentives for sources of energy that are low emission and low carbon. It will be paid for by additional taxes on incomes of very high income earners in annual $1 million plus range, and by having a corporate minimum tax of 15% for large corporations, including on profits overseas, that previously did not pay this tax. A wealth tax on unrealized capital gains of billionaires or other wealth of the richest Americans is left for a future Congress to consider for financing the key parts of climate change provisions, education and health care that were left out. The education and healthcare provisions need to be expanded to restore America's historic mission of upward mobility for all. A provision for Medicare to comprehensively negotiate prices with pharmaceutical companies that would be taken for granted in any advanced country as in Europe, is also left for a future Congress that understands and responds to the dire needs of families and workers in America for affordable healthcare medicine neglected by administration after administration for the last three decades.   ...

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This example of how Forest Laboratories hoped to market an antidepressant Lexapro to doctors through financial incentives to prescribe the drug is detailed in a document that was made public by the Senate's Special Committee on Aging. The document is the "Lexapro Fiscal 2004 Marketing Plan." Forest licensed Celexa from Lundeck of Denmark and brought it to the US market in 1998. Then as the drug's patent life was short it tinkered with it and developed a new version calling it Lexapro and introduced it in the US market in 2002. Withits marketing effort Lexapro had $2.3 billion in sales in 2008, while all the time generic versions of Celexa and other durgs in its class sell for afraction of the Lexapro price. For instance amonth's supply of 5 millgram tablets of Lexapro costs $87.99 at drugstore.com, while a month's supply of generic version of Prozac is $14.99. Forest spends a lot compared to its larger rivals on sending money to doctor's. In the plan $34.7 million was to go to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers that year. $36 million was to go to providing lunch to doctors in their offices. Asks Senator Herb Kohl, a Democrat from Wisconsin who is chairman of the Committee on Aging- "is the line between medical education and marketing blurred." For these companies there was no line. ...

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Andy Grove of Intel teaches a class at Stanford- he taught aclass earlier this year- and talks about his experiences. Some see Grove's disciplined management style as areflection of his experience escaping the Nazis from Czechoslovakia. Dr Grove says it comes from his experience at the CIty COllege of New York He recounts this in one of his books, where aparticular Professor helped mentor him but who was in the beginning very tough on the young Grove. Grove says that what impressed him most in those early years at City College was the way hard work and talent were rewarded and where students challenged their Professors without any attention to rank. Interestingly this is still true at many universities, and meritocracy prevails there. The opposite is true when one thinks of this at many corporations which gradually fall into astultifying mode where senior managers are not challenged and politics prevails. GM is a good example. Grove says he experienced this at Fairchild -where he worked with computer chip pioneers Moore and Noyce -with its elitist, back-stabbing and lax corporate culture. Senior executives at Fairchild walked in whenever they felt like, and younger employees were penalized or fired for similiar behaviour. When he took charge at Intel Grove imposed a strict arrival time of 8 am with latecomers forced to sign asheet. He also did not go along with trends like flexi-time and teleworking. He became known as ablunt and demanding manager, but afairminded boss who rewarded good ideas whatever the source. Asked about the strict arrival time Grove says that people don't understand that he was never that disciplined himself and he was not even amorning person. His view is that he wanted to avoid what he saw as aoutrageous double standard at Fairchild. With a better culture he was able to attract the best talent to Intel, and he used the strong discipline to improve the lousy manufacturing at Intel. Three decisions shaped Intel. The first, is the recognition of the strategic inflection point when current strategy is no longer viable, because unanticipated external forces make an existing business strategy obsolete. This happened when Intel got clobbered by the Japanese in the memory chip field it had dominated. And at such moments there are internal forces and inhibitions to overcome that make starting over or doing something totally different extremely difficult. For Intel this was the habit forming tendencies from having done one thing so well- the companies roots and the founders and engineering staff's knowledge and preferences lay in memory chips- such that that it became an emotionally stormy thing to break from this past. Grove made a complete U turn to go in another direction which he describes so well in his book -Only the Paranoid Survive. Timing is critical, and instinct and judgement is all that you have got to rely on. Its like a group of hikers in the woods and after suspecting that they are on the wrong track one of them says, "Hey guys I think were lost." Grove even describes the scene with acomparison to a scene in the World War II movie Twelve O'Clock High, where a new commander is called in to straighten out an unruly and undisciplined squadron of fliers in sel-destruct mode. The commander on his way to take charge, stops his car, steps out smokes acigarette while gazing into the distance. Then he he throws the cigarette down, grinds it with his heel and tell his driver "Okay Sergeant, lets go." Grove says he related to this scene in this decision at Intel, with every fiber of his being experienced this crisis personally, and learned what it takes to claw your way through a strategic inflection point, inch by excruciating inch. He says it takes objectivity, the willingness to act on your convictions, and the passion mobilize people into supporting those convictions. The second and third decisions was less gruelling but also courageous. The Intel Inside advertising campaign meant building abrand with customers even though Intel had never done this before. The decision to not have secondary suppliers and press the issue of manufacturing quality within Intel till Intel got it right also had never been done before. Andy Grove's strategic inflection point is what GM missed and set the process in motion towards bankruptcy. See the links in Intelilinks. The management style is also relevant to that discussion. Grove also provides insights in the Cross-Industry Insight Mechanism. He sees strategic inflectionpoints in autos and health care industries. He says the auto industry is going to be increasingly divorced from oil and the next big company will come in the auto battery technology field. He also believes health care and the pharmaceutical industry can learn from chipmaking. The clinical trials in pharmaceuticals take way too long, are slow-moving and bureaucratic. The pharmaceutical firms can learn from the fast "knowledge turns" in chipmaking, so that cycles of learning are accelerated....

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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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Rivaroxaban, will be reviewed by an FDA panel of outside experts to decide whether the drug used for anticlotting has a favorable risk-benefit profile. The drug is from Bayer A.G. and Johnson and Johnson. Rivaroxaban causes increased bleeding among patients in clinical studies than existing drugs used for anticlotting even though it does better at preventing clots from forming.

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The NYT Editorial Board on efforts in the U.S. Senate by lobbying groups to have the 2.3% tax on medical devices- to pay for medical coverage of the uninsured in the Obama health Care law- repealed.