In what one hopes will be the death knell for bloated one-size fits population approaches to designing individual treatment, the ACCORD study tried to see if getting everyone down to A1C level of 6 is better than a 7 when most diabetics have a tough time getting their A1C under control. Most people achieved the limit but in the process many high risk people who in the process of reducing their glucose levels suddenly died. The control group had fewer but more fatal heart attacks . That came with great effort on their part.
Some thoughts and observations:
1. After going through the 100 page protocol of the study and the ten year time frame you get the sense that if THIS is what comparative effectiveness research will look like, good luck. It will be a waste of time, money and effort compared to investing in research that attempts to figure out what is the best way to control or prevent disease in individuals.
2. Avandia is redeemed once again in a real world setting, such as it is. As the National Heart Blood and Lung Institute noted: Because of the recent concerns with rosiglitazone (Avandia), which is one of several medications used in ACCORD, researchers specifically reviewed data to determine whether there was any link between this particular medication and the increased deaths. To date, no link has been found. (For more on this issue, see http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=287 .)
3. But don't expect a mea culpa from Steven Nissen, the media or anyone else involved in this sorry story.
4. The Vice Chair of the Accord Steering committee? John Buse, the very same Buse that Senator Grassley and Rosa DeLauro are 'defending' against Dr. Yamada decade old criticism that Buse was way off base about the cardiovascular risks of....Avandia. Who owes who an apology?
5. Oh, The ACCORD trialists adjusted the protocols to ensure the trials met the endpoints. That is, it change how the trial was run to hit the A1C targets. Imagine if a drug company tried to do that!
Some thoughts and observations:
1. After going through the 100 page protocol of the study and the ten year time frame you get the sense that if THIS is what comparative effectiveness research will look like, good luck. It will be a waste of time, money and effort compared to investing in research that attempts to figure out what is the best way to control or prevent disease in individuals.
2. Avandia is redeemed once again in a real world setting, such as it is. As the National Heart Blood and Lung Institute noted: Because of the recent concerns with rosiglitazone (Avandia), which is one of several medications used in ACCORD, researchers specifically reviewed data to determine whether there was any link between this particular medication and the increased deaths. To date, no link has been found. (For more on this issue, see http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=287 .)
3. But don't expect a mea culpa from Steven Nissen, the media or anyone else involved in this sorry story.
4. The Vice Chair of the Accord Steering committee? John Buse, the very same Buse that Senator Grassley and Rosa DeLauro are 'defending' against Dr. Yamada decade old criticism that Buse was way off base about the cardiovascular risks of....Avandia. Who owes who an apology?
5. Oh, The ACCORD trialists adjusted the protocols to ensure the trials met the endpoints. That is, it change how the trial was run to hit the A1C targets. Imagine if a drug company tried to do that!
