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News Lawyers forecast a flood of Avandia litigation Reuters News, 5-23-07 Editor's Notes:
There is one certainty in the ongoing debate surrounding a potential increase in heart disease risk for patients taking GlaxoSmithKline's diabetes medicine Avandia: No matter what the science says, lawsuits will pile up against the company in short orderand perhaps siphon billions of dollars away from drug research into years of costly litigation.
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For drug makers, a downside to full disclosure The New York Times, 5-23-07 Editor's Notes:
File this story under "damned if you do, damned if you don't." Even as companies comply with demands from Congress and the media to put ever more clinical trial data into public repositories on the Web, they expose themselves to lawsuits and accusations of hiding safety data. The problem is that safety signals that come from the meta–analyses of many different clinical trials—many of them small and of uncertain clinical value—are very much open to interpretation and debate.
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Avandia concerns reopen a wider debate Wall Street Journal, 5-23-07 Editor's Notes:
This article, from the Wall Street Journal, reports that Avandia's class of drugs, called peroxisome proliferated–activated receptors or PPARS, have a long track record of both extraordinary promise and safety problems. Companies are working hard to maximize the benefit of PPAR drugs while minimizing the risks; hopefully, the backlash against Avandia will not shelve promising research in this area.
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Commentary Rosiglitazone and Cardiovascular Risk Curt D. Furberg, M.D., Ph.D., Bruce M. Psaty, Ph.D., New England Journal of Medicine, 5-24-07 Psaty and Furberg have written a thoughtful and balanced review of the meta–analysis of Avandia safety data published by Dr. Steve Nissen and his co–authors in the same issue of the New England Journal. It is well worth reading in full.
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We’re seeking more data: FDA protects public health with careful analysis, not snap judgments Andrew von Eschenbach, USA Today, 5-23-07 Dr. von Eschenbach, the Commissioner of the U.S. Food and Drug Administration, defends the FDA's handling of emerging safety data on potential heart risks associated with the diabetes drug Avandia.
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Canadian media needle Sicko Peter Howell, Toronto Star, 5-20-07 Howell, reporting from Cannes, writes that Michael Moore's mockumentary on American health care, Sicko, is receiving a chilly reception from Canadian journalists who question his rosecolored depiction of Canadian health care.
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Does a drug firms free lunch influence doctors? Scott Lassman, The Boston Globe, 5-18-07 Lassman defends the pharmaceutical industry’s physician marketing practices against allegations that physician-industry relationships skew patient health care. Far from hurting patient care, Lassman argues, marketing actually helps to improve it.
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Doctors, drugs, and the poor Atul Gawande, The New York Times, 5-17-07 Gawande suggests that international drug companies have a moral obligation to help make expensive new drugs affordable in lowincome countries. This judgment seems correctbut policymakers and NGOs also have a responsibility to protect companies patent rights and offer them a fair return on their investment. This will help companies develop the next generation of miracle cures for poor and rich nations alike.
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Sometimes, what’s needed is a nudge David Leonhardt, The New York Times, 5-16-07 Leonhardt has written a short but fascinating article on how policymakers can "nudge" consumers into making better decisions without restricting choice or using heavy handed regulations.
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Research Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes Steven E. Nissen, M.D., Kathy Wolski, M.P.H.,, New England Journal of Medicine, 5-21-07 Nissen and his colleagues perform a metaanalsysis on published clinical trial data on the diabetes drug Avandia and conclude that it may be associated with a 43% increase in heart attack risk for some patients.
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