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Diabetes

Drug Safety Critic Hurls His Darts From the Inside

See the blog posting "Avandia, the Drug Safety Debate and How to Get a Nobel Prize" which you can find at: http://blog.aesisg roup.com/2007/07/2 2/more-on-the-avan dia-controversy-an d-its-implications -for-the-core-valu es-of-medical-scie nce.aspx Discusses some reasons why it can be so difficult, and controversial to get safety information out.  (Jul 23, 2007 | post #1)

Abbott and Abbott Fund Expand Commitment to Fight Pediatr...

Another example of the growing importance of "medical diplomacy." For more on this - with specific reference to the Abbott-Thailand controversy, see the article: "An Unfolding Tragedy: Balancing Act between Innovation and Access" which can be found at: http://blog.aesisg roup.com/2007/04/3 0/an-unfolding-tra gedy-balancing-act -between-innovatio n-and-access.aspx Efforts such as the Abbott Fund will help mitigate some of the misunderstanding and miscommunication that often underlies such conflicts.  (Jul 22, 2007 | post #1)

GlaxoSmithKline

Diabetes Drug Tied To Heart Risks

For any article on the Avandia problem and its implications see: "FDA: Tortoise, Hare or Something Else" which can be found at: http://blog.aesisg roup.com/2007/07/0 2/fda-tortoise-har e-or-something-els e.aspx  (Jul 22, 2007 | post #113)

Merck

Merck wins Vioxx case

Yes. It's true of course: everything in life involves risk, whether it be taking a medication, or simply walking down the stairs. One important difference, however, is that the premium on safety has increased and an article from last year "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " which can be found at "http://blog. aesisgroup.com/200 6/05/01/drug-safet y-debate-to-yield- big-changes-grow-m ore-controversial. aspx" highlights some of the major reasons behind this essentially cultural shift.  (Jul 22, 2007 | post #64)

Guidant

Talks may foretell Guidant settlement

For a discussion on the growing importance of drug/device safety which has literally caught manufacturers off guard, see: "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " at: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx. This article outlines some of the subtle reasons why something that wouldn't have been so much of an issue twenty/thirty years ago is not front-and-center.  (Jul 22, 2007 | post #1)

Guidant

Guidant Will Settle Heart Defibrillator Cases for $175 Mi...

For a discussion on the growing importance of drug/device safety which has literally caught manufacturers off guard, see: "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " at: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx. This article outlines some of the subtle reasons why something that wouldn't have been so much of an issue twenty/thirty years ago is not front-and-center.  (Jul 22, 2007 | post #1)

Guidant

Medtronic Agrees to Pay $75 Million to End Defibrillator ...

For a discussion on the growing importance of drug/device safety which has literally caught manufacturers off guard, see: "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " at: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx. This article outlines some of the subtle reasons why something that wouldn't have been so much of an issue twenty/thirty years ago is not front-and-center.  (Jul 22, 2007 | post #1)

Guidant

Boston Scientific settles some suits from Guidant buy

For a discussion on the growing importance of drug/device safety which has literally caught manufacturers off guard, see: "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " at: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx. This article outlines some of the subtle reasons why something that wouldn't have been so much of an issue twenty/thirty years ago is not front-and-center.  (Jul 22, 2007 | post #1)

Boston Scientific

Guidant's legal woes give owner heartache

For a discussion on the growing importance of drug/device safety which has literally caught manufacturers off guard, see: "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " at: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx. This article outlines some of the subtle reasons why something that wouldn't have been so much of an issue twenty/thirty years ago is not front-and-center.  (Jul 22, 2007 | post #2)

Boston Scientific

23,000 Pacemakers and Defibrillators Recalled

For a discussion on the growing importance of drug/device safety which has literally caught manufacturers off guard, see: "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " at: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx. This article outlines some of the subtle reasons why something that wouldn't have been so much of an issue twenty/thirty years ago is not front-and-center.  (Jul 22, 2007 | post #3)

Merck

Ala. man loses lawsuit against Vioxx maker Merck

For an article looking a little "under the hood" at the Vioxx tragedy, see: "The Devil’s in the Details: A Closer Look at Merck’s Vioxx Trials" which can be found at: http://blog.aesisg roup.com/2006/08/0 7/the-devils-in-th e-details-a-closer -look-at-mercks-vi oxx-trials.aspx It explains some of the potential rationale behind Merck's defense of these numerous suits. Specifically relating to the difference between short-term and long-term use. For more general articles on the developing importance of drug safety and its implications for FDA reform, see: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx and http://blog.aesisg roup.com/categorie s/FDA%20Reform.asp x I'm not a lawyer, not a judge and not involved in the case and hence my purpose is not to apportion blame. Of course, I do hope that this (and other such) tragedies need to be prevented and to the extent there may be "systemic " problems, these should be addressed.  (Jul 22, 2007 | post #28)

Merck

Vioxx Jury Awards $47.5M to Idaho Couple

For an article looking a little "under the hood" at the Vioxx tragedy, see: "The Devil’s in the Details: A Closer Look at Merck’s Vioxx Trials" which can be found at: http://blog.aesisg roup.com/2006/08/0 7/the-devils-in-th e-details-a-closer -look-at-mercks-vi oxx-trials.aspx It explains some of the potential rationale behind Merck's defense of these numerous suits. Specifically relating to the difference between short-term and long-term use. For more general articles on the developing importance of drug safety and its implications for FDA reform, see: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx and http://blog.aesisg roup.com/categorie s/FDA%20Reform.asp x I'm not a lawyer, not a judge and not involved in the case and hence not seeking to apportion blame. Of course, I do hope that this (and other such) tragedies need to be prevented and to the extent there may be "systemic " problems, these should be addressed.  (Jul 22, 2007 | post #14)

Merck

Plaintiffs Lawyers Choose Lanier to Try Multiple Vioxx Ca...

For an article looking a little "under the hood" at the Vioxx tragedy, see: "The Devil’s in the Details: A Closer Look at Merck’s Vioxx Trials" which can be found at: http://blog.aesisg roup.com/2006/08/0 7/the-devils-in-th e-details-a-closer -look-at-mercks-vi oxx-trials.aspx It explains some of the potential rationale behind Merck's defense of these numerous suits. Specifically relating to the difference between short-term and long-term use. For more general articles on the developing importance of drug safety and its implications for FDA reform, see: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx and http://blog.aesisg roup.com/categorie s/FDA%20Reform.asp x I'm not a lawyer, not a judge and not involved in the case and hence not seeking to apportion blame. Of course, I do hope that this (and other such) tragedies need to be prevented and to the extent there may be "systemic " problems, these should be addressed.  (Jul 22, 2007 | post #14)

Merck

Jury Clears Merck in Latest Vioxx Trial

For an article on drug/device safety which highlights why this (and other issues such as Avandia) have gotten so important, see: "Drug /Device Safety Debate to Yield Big Changes, Grow More Controversial " at: http://blog.aesisg roup.com/2006/05/0 1/drug-safety-deba te-to-yield-big-ch anges-grow-more-co ntroversial.aspx The implications of this have been a number of proposals around FDA reform.... Not to blame either the FDA, the company or anyone but to propose changes to the system that hopefully will minimize such tragedies. See the articles at: http://blog.aesisg roup.com/categorie s/FDA%20Reform.asp x and feel free to post comments as you see fit. Open discussion and transparency ultimately tends to prevent such problems.  (Jul 22, 2007 | post #25)

Merck

Jury Clears Merck in Latest Vioxx Trial

For an article looking a little "under the hood" at the Vioxx tragedy, see: "The Devil’s in the Details: A Closer Look at Merck’s Vioxx Trials" which can be found at: http://blog.aesisg roup.com/2006/08/0 7/the-devils-in-th e-details-a-closer -look-at-mercks-vi oxx-trials.aspx It explains some of the potential rationale behind Merck's defense of these numerous suits. Specifically relating to the difference between short-term and long-term use.  (Jul 22, 2007 | post #24)

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