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Chantix Pfizer's anti-smoking medication faces new questions as Safe Medication Practices, a drug safety group, releases a report that shows 988 accidents linked to Chantix in the USA during the 4th quarter 2007. The FAA reacted to this report by banning the use of Chantix by pilots and air traffic controllers. Chantix has already been connected with psychiatric problems and this report shows links to heart trouble and diabetes.

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The changing attitudes to regulation after serious regulatory failures in the last years of the Bush administration. The temper and mood of the new Obama administration.

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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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US Senate investigation on the overuse of heart stents at hospitals and the heavy promotion of heart stents by medical stent device makers. Abbott Labs, Boston Scientific, and Medtronic are the three largest stent device makers in the US. Medicare spent $25 billion for heart stent procedures in six years to 2009.

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FDA's approach to Eli Lilly's drug Prasgrel which is more effective than Plavix for preventing heart attacks but can lead to fatal bleeding in some patients. The other side of the picture is that 30% of patients are not suited for Plavix, and these patients could have an alternative. In weighing the risks and the benefits, and of letting some patients who may be suited to Prasugrel have access to the drug, the FDA has to find the right approach. An FDA panel was set to recommend whether to approve the drug and under what conditions.

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The FDA relaxes some of the restrictions on anemia drugs of J&J and Amgen used by cancer patients after protest letters.

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Warning labels for the diabetes drug Avandia and a great deal of agreement that Avandia does pose some higher risks for the heart is how the FDA concluded its vote and discussion on what to do about Avandia for the safety of users.

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FDA and the cholesterol drug Cordaptive which the FDA rejected

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The FDA in heightened concern for safety decides not to follow an advisory panel's close 7-6 vote that Doribax for hospital acquired pneumonia was efficacious, and a 8-5 vote that it was safe. The FDA is taking more time to make decisions and asking for more data. In this case it paid attention to the questions raised by some advisory panel members about the design aspects of the study used to test the drug.

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Questions whether a study by Genzyme is strong enough to merit expanded approval of a drug called Myozyme to treat Pompe disease, that affects a person's muscle and respiratory function. It is from the lack of an enzyme aci alpha-glucosidase needed for muscle development and function.

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Judith Warner coins the phrase "dysregulation," for the cultural phenomena that may be behind the lack of restraint exercized in everthing that relates to personal lives like obesity, to the lack of regulation in the gulf and financial crisis. Citing Whybrow's book, "American Mania: When More Is Not Enough," she points to a disturbance in the national psyche, something that disturbs some inner clock or mechanism, that disturbs some inner balance that is built into us from the beginnings of man in the universe.

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See the related piece in BW