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Abbott's decision to raise the price of AIDS drug Norvir 5 fold in 2003, and how it undercut Glaxo's drug Lexiva which is used in combination with Norvir. Abbott included Norvir ingredients in a new drug Kaletra and this was priced cheaper than other AIDS drugs when it increased the price of Norvir. Glaxio is now suing Abbott for this pricing practice.

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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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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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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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Peter Orszag's role in the healthcare debate and the formulation of health care policy proposals. One proposal of Orszag, who heads the Congressional Budget Office, is to set up a new agency with powers to cut spending and implement changes in Medicare. Says Orszag, "one of the reasons we have such disjointed and skewed incentives is that we have an excessively political process." At a recent meeting with House Democrats, one Congresswoman said her top priority is winning higher payments for oxygen suppliers, and Orszag was taken aback. For years officials have been trying to cut payments to oxygen and medical equipment suppliers, which are said to be inflated. When a new competitive bidding process was set to take effect last year, industry supporters in Congress were able to delay the plan, and these supporters are still fighting to block changes says the WSJ. Here is a 40 year old Orszag, with degrees from Princeton and London School of Economics, who got his early experience in the Clinton adminstration at age 24. He then followed this with a number of policy oriented jobs, ending with appointment to head CBO in 2007. And he faces the whole system of Congressmen from both parties beholden to interests in the healthcare industry, who provide the donations for them to finance their election campaigns. Dan Eggen describes this in the Washington Post, 7/21/2009. Max Baucus of Montana, and to some extent Grassley of Iowa, are senators from both parties who Eggen points out are beholden to the healthcare industry because of large donations they receive from the interests in the healthcare industry. These interests want to see their payments system protected. The further escalation in health care costs, which would make the whole healthcare system unaffordable even as it delivers poor results, can only be prevented by making cost control an exercize that is not influenced by healthcare industry donations. Jackie Calmes describes the huge hurdles in achieving a deficit neutral move to universal health care in the U.S. in the NYT 6/26/2009. See the link. The exchange between Grassley and Orszag on the issue of the $177 billion in savings needed from the payments to health insurers under the Medicare managed care plans- which allow seniors to obtain Medicare coverage outside the government run program -went as follows. These are dubbed overpayments by outside experts and efforts have been made to cut them in Congress. When Mr Grassley raised concerns about the impact of such cuts in a hearing, -and Grassley has opposed the cut for this overpayment to insurers- Orszag responded saying: "I very firmly believe that capitalism is not founded on excessively high subsidies to private firms. This is what this system delivers right now." ...

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Blue Dog or corporate shills, who are they, asks Thomas Frank. He reminds readers that Illinois Senator Paul Douglas advised people in 1932 not to expect much from the Democratic party. Douglas said the Democratic party was more like alifeboat for business interests, when the going got tough with the Republicans, business interests simmply used this lifeboat to get away. So he says call these Blue Dogs caucus the Lifeboat caucus, and you get closer to the mark. He points out that the Blue Dogs are some of the leading fundraisers in Congress. See the link to Max Baucus in the Senate, who the NYT describes as a leading fundraiser from Montana.

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William Daley, the head of Washington lobbying for JPMorgan Chase, is appointed Chief of Staff to President Obama. He also serves on the board of directors of Boeing and Abbott Labs, companies which a strong interest in Washington lobbying. William Daley is with Chase since 2004, and was hired primarily to strengthen Chase's Chicago connections. In the past he has served as the main liasion with the White House. In 2007 he joined the bank's senior leadership as head of its new Office of Corporate Social Responsibility, which oversees the company's global lobbying efforts.

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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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Dana Milbank of the Washington Post on Republican consultant Castellanos's memo to GOP strategists on how to kil the health care legislation in Congress. She points out the language, words like hasty "experiment" that Castellanos suggested that are figuring prominently and frequently in Republican National Committee chairman Michael Steele's remarks, like the talk he gave at the National Press Club on July 20, 2009.

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Stricter warnings on Amgen's Epogen and Aranesp, and J&J's Procrit, Anemia drugs.

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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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Elizabeth Rosenthal looks at Obamacare's contribution to cost containment in 2013-2014. Rosenthal says its is a kind of delicate maneuvring at the edges, because serious work needs to be done. The fee-for-service and many of the drivers for increases in medical costs, the old system of pricing, are still in place. In 20 years at the current rate and after Obamacare health care will still take 25% of the U.S. budget if nothing is done. Healthcare costs are about half that of the U.S. in some of the advanced European countries. She calls Obamacare a trickle down theory of cost containment becaue it leaves most of the drivers for cost increase in place and works at the margins. Princeton economist Uwe Reinhardt calls it an ugly patch on a somewhat ugly system. Rosenthal cites the armies of consultants anticipating every move to reduce prices, and working on "strategic billing'' to increase revenues for hospitals and doctors. For those who say the prices are now up more slowly than in the past, Michael Chernew of the Harvard Medical School, has this to say- its like a diet, reminding us that that we haven't even lost weight, just gaining weight slower than before. ...

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Baucus is a six term senator from Montana. He won easy re-election in the fall. Question are being raised about the extent of fundraising Baucus is doing even as he is conducting the negotiations for writing up the health care reform bill. He continues to accept donations from health care executives and health care companies. Public Citizen advocacy group says that Baucus's fundraising in the middle of the health care debate is very troubling. As chairman of the Senate Finance Committee, Baucus is a key person in the health care legislation development.The Washington Post says health care companies gave Baucus $1.5 million in 2007 and 2008 as he began to hold hearings for the health care reform debate. The health care industry gave $170 million to federal lawmakers in 2007 and 2008, with 54% going to Democrats, according to the Center for Responsive Politics. Senator Grassley of Iowa, the ranking Republican in Baucus's committee received more than $2 million from the health care industry since 2003. House Ways and Means Committee chairman Rangel took in $1.6 million, and ranking Republican Dave Camp $1 million. Clearly any new health care legislation will fall short on achieving the critical reduction in health care costs that is needed to help the U.S. economy as long as lawmakers are beholden to lobbyists and donations....

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Experts say Chief Justice Roberts somehow found a path through in bridging the ideological divide and avoiding a show of partisanship in an election year. He somehow navigated and found a path through in his vote on the U.S. healthcare law letting it stand. Early on Roberts advocated "judicial modesty and humility" in jurisprudence. He compared the judge's role to that of an umpire in baseball during the 2005 confirmation hearings. The umpire would not pitch or bat, his job would be to call balls and strikes. It was seen as a determmined show of independence at a time when Justice Kennedy was seen as the swing vote. He has also earned political capital to be able to vote independently on other issues before the court instead of becoming embroiled in controversy about the role of the Court in overturning the work of Congress during the early part of the Obama administration.

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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 influence of lobbyist on members of Congress just as the Obama administration, having studied the failure of the Clinton submitted healthcare plan try a different strategy of letting Congress come up with a healtcare plan. $133 million was spent in the second quarter alone by healthcare industry lobby interests creating headaches for reform efforts and the Obama administration.

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EpiPen's price has jumped 550% over 8 years. Mylan Pharmaceuticals is dominant in the $1 billion market for treating serious allergic reactions. Mylan acquired reights to sell EPiPen in late 2007. A pack of two list price is now $608.61. Last Nov. Sanofi's competing product Auvi-Q was recalled giving Mylan price dominance. A problem for consumers is that EpiPen expires in one year. Mylan launched a campaign to make parents aware of the product for children with peanut and other allergies, and also lobbied the governments to make ready supply of EpiPens available in schools and other public places. Now the controversy over price increases, with Hillary Clinton citing this as an example of exorbitant pharmaceutical pricing, is likely to change the environment around EpiPen and other overpriced drugs or healthcare products.

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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. ...