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A Vermont musician could not practice her livelihood after her arm was amputated because of gangrene. The gangrene developed as a result of a physician's assistant at a clinic using a a wrong technique for adminstering Phergan for nausea. The PA used IV Push instead of an IV drip or intravenous which is the right method. He missed the vein and and hit an artery causing the gangrene to develop. A Vermont state court awarded Ms Levine $6 million from Wyeth Pharmaceutical. Now the Supreme Court upheld the Vermont Court, with Justices Kennedy, Souter, Ginsberg, and Breyer joining Justice Stevens. Justice Thomas concurred. Scalia, Roberts and Alito were in dissent. Wyeth had a FDA approved label that warned against "inadvertent intra-arterial injection," but it did not say do not use IV Push. Justice Stevens writing the majority opinion said Wyeth's reading of the regulation was "cramped" and based on a "fundamental misundrstanding." He said "the manufacturer bears responsibility for the label at all times," and affirmed the Vermont Court's opinion that Federal law provides afloor not a ceiling for state regulation." ...

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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to have the 2.3% tax on medical devices- to pay for medical coverage of the uninsured in the Obama health Care law- repealed.

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A health care practitioner says the real problem is the high cost of medical care in the U.S. when compared to other countries. She points out that the Obama bill in 2008 did not take effective steps to bring down the cost of health care before enacting legislation to cover the uninsured, leading to higher premiums for the middle class. The link between healthcare and profits is seen as the main problem. 

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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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The use of Zyprexa in nursing homes, and Lilly's marketing of the drug as "requiring fewer skilled nursing staff hours", and "reduced caregiver stress." The lawsuit alleged that this meant it was " an effective chemical restraint for demanding, vulnerable and needy patients." Zyprexa has the risk of life-threatening infections like pneumonia and of heart failure in elderly patients. Lilly also marketed the use of Zyprexa to treat disruptive children, even though there are side effects of severe weight gain and metabolic disorders. The case is being prosecuted by the US Attorney's Office of the Eastern District of Pennsylvania. In the negotiations Lilly agreed to pay $1.2 billion to 31,000 Zyorexa plaintiffs. This is the biggest case and settlement of its kind.

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Abbott is placed on a five year probationary period by the U.S. Justice Department. This comes after the $1.6 billion legal settlement for aggressive marketing practices to sell the drug Depakote in nursing homes.

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Lobbying by the pharmaceutical and health care industry and U.S. president Obama's promises to the industry as part of his shaping the health care law.

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Lobbying by the American pharmaceutical industry and the Obama administration. Emails showing the negotiations between the administration and the pharmaceutical companies.

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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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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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An indepth look at Mexico, its assets, its huge potential and what is holding Mexico back. It ranks much higher than Brazil in many respects- higher investment as a fraction of its GDP, technical education, an easier place to do business, less regulation, better management talent, more industrialized. In 2010 Mexico had $400 billion of business with the U.S. With rising Chinese wages Mexico is an attractive place for foreign investment, with a hardworking and educated workforce. Mexico suffered badly during the 2008 recession in the U.S. It is trying to reduce its dependence on exports to the U.S in key areas such as the automotive industry. Exports to the U.S. by the automotive industry are now 65% of the total, and the auto industry association in Mexico is working to bring this figure to 50% by exporting to Latin America and Europe. Economic growth was 5.4% in 2010, and expected to be 4-5% in 2011. Drug violence may have reduced the growth by one percentage point according to some estimates. The think tank, Mexican Institute for Competitiveness, estimates that economic growth would be 2.5% percentage points higher if labor market and competition laws are changed, and the oil industry is opened up to foreign investment as happened in Brazil. A study by OECD and the Federal Competition Commission (CFC) of Mexico has shown that 31% of Mexican household spending goes to products operating in high price monopolistic or oligopolistic markets. The bottom ten percent spend even higher proportion of incomes, around 38%, for products supplied in such markets. This includes pharmaceuticals, airline travel, banking, and electricity. Taking on these cartels is a difficult task. The CFC is beginning to take the first steps in this direction, in what will be a long road to fair prices for Mexican consumers. Banking was opened to Wal-Mart. The collapse of Mexicana was an opportunity to auction landing slots to other airlines. An auction system has been developed by CFC for drugs. A new competition law sets penalties for collusion in pricing, with upto 10 years in jail. And Carlos Slim's telephone monopoly was fined $1 billion for its telecom monopoly practices. In 2009 the Calderon government shut down Luz y Fuerza, a state electricity company costing the governmment $3 billion in subsidies for an highly inefficient operation. ...

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Just as the drug industry is more getting more dependent on the government with the medicare drug benefit raising the retail drug purchases paid by government to 34% in 2006 from 28% in 2005, the industry is facing more governmental scrutiny, from the FDA, from Congress from the public, and during this election campaign. Rep .Rosa DeLauro, who heads the House appropriations subcommittee that has oversight over FDA funding compares the drug industry to the tobacco industry saying that it requires the same amount of scrutiny. At the same time the drug industry is aware of the changes in the public mood and the recent controversies over drug studies, such as the one on Vytorin and other controversy. It is initiating some voluntary changes, registering clinical trial results, submitting commercials to the FDA before they air, and under pressure from medical journals registering trials before they are performed. A new law will requires and its not clear whether the drug industry is dragging its feet and then making changes when there is increasing public pressure. This is the feeling of the medical journals like the Journal of the Medical Association and the New England Journal of Medicine. JAMA's editors will be keeping up this pressure as they have more articles showing how the drug industry manipulates data and the need for public skepticism of information that comes out of the drug industry. The New England Journal editors expressed the need to publish information that helps doctors get all the available information, and not just the information from the drug industry that makes the drug look better than it really is, such as the information and analysis it provided on antidepressant medications. The chairman of the energy and commerce investigations subcommittee Rep. Stupak, finds the advertising for drugs contains information that cannot be backed up and not true ethically, medically, or legally. As this reflects the public mood look for more investigations in Congress and investigative research by the journals. On the issue of importation of drugs from Canada there is bipartisan support as both Senator McCain and Senator Clinton support importation. Clinton supports legislation that allows the FDA to approve new generic versions of biotech drugs which would lower prices of biotech drugs. And with the US consumer budget facing strains in a recession there will be increasing pressure and demands for relief in the area of drug prices, especially for the elderly and uninsured and from corporate payors. ...

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Thre drug companies are placing bets on the vaccine business. Johnson and Johnson paid 302 million euros for 18% of Dutch biotech company Crucell NV, to jointly develop vaccines. Abbott Labs says it will acquire a unit of Belgian conglomerate Solvay SA for 4.5 billion euros in adeal that includes a vaccine business. And Merck obtained the marketing rights for a seasonal flu vaccine from Australia's CSL Ltd. This follows Pfizer's Wyeth acquisition. Low prices, high costs and fear of lawsuits made most drug makers to exit the business in the 1980's and 1990's. Now vaccine sales are growing faster than other prescription drugs and are largely protected from generic competition. And government agencies here in the USA and around the world are reliable buyers of vaccines as they seek to stockpile medicines that could be needed in aflu outbreak. Merck never exit the vaccine business and now makes 8 of 10 vaccines recommended for adults. Flu and other vaccines are especially attractive for entering drug markets in Brazil and China and developing countries. Governments lke the idea of lowcost prevention at $10 adose, and with this new relationships are developed in these countries. And even at price of $10 or $20 a dose they provide asteady stream of revenue.Vaccines are estimated to generate $21.5 billion in revenues by 2012 according to Sanofi-Aventis SA, which is a leading vaccine maker....

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Walmart CEO Mike Duke talks with Journal reporters Ann Zimmerman ans Miguel Bustillo. He says customers are under alot of pressure, and he sees what they buy, delaying purchases and the buying at midnight on the first of the month. Apparel sales are down and so are discretionary purchases and basic necessities and things like vitamins and the $4 generic pharmaceuticals are up. Walmart sees 140 million customers in stores every week, and has information systems to show how customers are buying, which gives it a unique lens through which to see changes in buying behaviour after the financial crisis and increasing numbers of jobless. Customers are saying he says that I will invest in basic needs and defer discretionary purchases. Among other things he talks about sustainability as something his company is paying attention to.

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Business Week's Chad Terhune points out that the health reform bill that passed Congress will do little to restrain the overbilling by pharmaceutical companies, medical device and equipment makers. Chad cites numbers from the U.S. Health and Human Services Department that shows $47 billion in Medicare spending went to dubious claims in the year ending Sept 30, 2009. This is 10% of the $440 billion Medicare program. And 10% of the Medicaid program also goes to dubious claims. Consider then that Congres allocated $10 million annual increase to fight fraud. A suit filed by a former Siemens manager at the federal court in Philadelphia states that Siemens routinely overbilled the Veterans Affairs Department and other governmental agencies by humndreds of millions of dollars for MRI and CT scan machines.

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Gail Collins on why Senator Lieberman is opposing the public option, expanding Medicare Eligibility and other parts of the health care bill.

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Samuelson points to the risks to the American economic growth from excessive health care costs. This is hurting take home pay and shows up in consumer spending. It is hurting government spending in other areas such as needed infrastructure spending and efforts to reduce the deficit. This hurts private capital investment to create jobs because of lower demand from constricted consumer spending. The U.S. budget has as its largest single expense 27% on health care compared to 20% on defense the next largest expense, with growth in health care spending taking this to one third of the budget in coming years. Without addressing health care, says Samuelson, the Supercommitte in Congress even if successful at deficit reduction will basically have failed to do its job, and it did not have the time, resources or conviction to do this. According to a new study from the Organization for Economic Cooperation and Development (OECD), U.S. healthcare spending per person is $7,960 per person in 2009. This compares with Norway $5,352, Britain $3,487, France $3, 978, an OECD average of $3,233. Life expectancy in the U.S. is 78.2 years, compared to Japan 83 years, OECD average of 79.5 years. Chile and the Czech Republic have life expectancy equal to the U.S. Except for cancer care where the five year survival rate is 89.3% in the U.S. and the OECD average is 83.5%, the U.S. lags far behind in much needed critical areas such as diabetes and asthma. Rates of emergency hospitalization for asthma are 3 times that in France and 6 times that in Germany and Italy. The U.S. has fewer doctors per thousand population and higher cost per medical procedure- with more frequent use of the costliest procedures- creating a supply shortage that induces higher prices, and less preventive and early action care through physician visits. The number of practicing U.S. doctors is 2.4 per thousand population in the U.S. compared to 3.1 per thousand for the OECD average; and number of annual doctor consultations 3.9 per capita in the U.S. versus 6.5 for the OECD average. Appendectomy cost $7,962 in the U.S., $5,004 in Canada and $2,943 in Germany. Coronary angioplasty cost $14,378 in the U.S., compared to $9,296 in Sweden, and $7,027 in France. Knee replacement cost $14,946 in the U.S., $12,424 in France, and $9,910 in Canada. Knee replacements, angioplasties and MRI exams are twice as common in the U.S. compared to the OECD countries. ...

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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....