Steve Nissen secretly recorded conversations he had with Glaxo SmitkKline execs about his meta-analysis of 42 studies showing an increased risk of CV events.
http://www.nytimes.com/2010/02/23/health/23niss.html?pagewanted=2
I am sure that Nissen was waiting for the climactic scene when the CEO either tries to bribe him or have him poisoned in his hotel room.
Unfortunately, the response he received from the GSK higher-ups was suggestion to do an analysis about when people actually had their heart problems since other studies did not show CV side effects in the short time frame he was showing (See below). And the worst thing about that response was the fact that GSK did not offer to pay him tens of millions of dollars to do such a study, a study Nissen has gladly done before using his ultrasound measurement of heart problems..
Of course there is no mention of Nissen secretly sending a copy of his NEJM paper to Congress in violation of the embargo requirement and not sharing it with the FDA.
Nor is there any mention of what NHLBI said in light of the RECORD study... "NHLBI staff reviewed the scientific findings and arranged for Data Safety and Monitoring Board (DSMB) meetings for both trials. The BARI 2D and ACCORD DSMB meetings reviewed in-depth analyses of cardiovascular disease rates in patients receiving rosiglitazone versus other diabetes drugs in the two trials. The DSMBs also conducted a thorough review of the recently published data on heart attacks and deaths in patients receiving rosiglitazone.
Each DSMB provided recommendations to the NHLBI on how the totality of evidence on rosiglitazone should affect the conduct of BARI 2D and ACCORD. The NHLBI carefully reviewed the DSMBs' recommendations and also thoroughly reviewed the recently published meta-analysis of rosiglitazone and the RECORD trial, along with the accompanying editorials published online May 21 and June 5 by the New England Journal of Medicine. "
http://www.nhlbi.nih.gov/new/press/07-rosi-qa.htm
Oh...
The NHLBI concurs with the DSMBs' recommendation that both the BARI 2D and ACCORD data, viewed in the context of the recent publications, contain no observations that would justify a recommendation to terminate rosiglitazone treatment in the research setting of either study.
The New York Times claims that the RECORD study was poorly designed. In fact, the interim RECORD analysis done to follow up on Nissen's claim was had limited statistical power because of an unexpectedly low event rate and incomplete follow-up (a mean of 3.7 years instead of the planned median of 6 years). Still the interim analysis had the same internal statistical reliability as Nissen's analysis: What the Times fails to note is that when Nissen lumped in all 42 studies, he glossed over the fact that the individual studies he looked at were not conducted the same way, with patients with the same disease or drug dose. Further, the 42 studies were small and overall event rates were low, partially because trial durations were relatively short ranging from 24 to 52 weeks, about 25 to 50 percent shorter than RECORD. As anyone who does statistics for a living will tell you, adding up a bunch of underpowered and short term studies does not give you a well-powered study with long term predictive effects.
Here's what one article -- written by Sanjay Kaul and colleagues said about the study: "The investigators' own subgroup analyses, which were limited to the small trials alone or to the 2 large trials (DREAM [Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication] and ADOPT [A Diabetes Outcome Progression Trial]), did not demonstrate statistically significant associations (1). Furthermore, one might reasonably question whether results from the 3 trials that targeted patients with Alzheimer disease (n = 1) or psoriasis (n = 2) who did not have diabetes should be combined with results from other trials that included patients with diabetes or prediabetes. Because rosiglitazone is already contraindicated in patients with heart failure, one might also reasonably limit the assessment of risk to patients without that contraindication and not combine data from the single study in patients with diabetes who had congestive heart failure with data from other studies. Incidentally, this trial exhibited the highest number of myocardial infarctions (n = 5) and cardiovascular deaths (n = 3) among all the small trials in the rosiglitazone treatment group (1).
Read Article
Some people can't handle not being FDA commissioner.... Meanwhile we will keep a running count of the media types who fail to put Nissen, Avandia and other studies about the medicine in context and simply write stories based on the narrative of the insider exposing (once again) the evil drug company.
http://www.nytimes.com/2010/02/23/health/23niss.html?pagewanted=2
I am sure that Nissen was waiting for the climactic scene when the CEO either tries to bribe him or have him poisoned in his hotel room.
Unfortunately, the response he received from the GSK higher-ups was suggestion to do an analysis about when people actually had their heart problems since other studies did not show CV side effects in the short time frame he was showing (See below). And the worst thing about that response was the fact that GSK did not offer to pay him tens of millions of dollars to do such a study, a study Nissen has gladly done before using his ultrasound measurement of heart problems..
Of course there is no mention of Nissen secretly sending a copy of his NEJM paper to Congress in violation of the embargo requirement and not sharing it with the FDA.
Nor is there any mention of what NHLBI said in light of the RECORD study... "NHLBI staff reviewed the scientific findings and arranged for Data Safety and Monitoring Board (DSMB) meetings for both trials. The BARI 2D and ACCORD DSMB meetings reviewed in-depth analyses of cardiovascular disease rates in patients receiving rosiglitazone versus other diabetes drugs in the two trials. The DSMBs also conducted a thorough review of the recently published data on heart attacks and deaths in patients receiving rosiglitazone.
Each DSMB provided recommendations to the NHLBI on how the totality of evidence on rosiglitazone should affect the conduct of BARI 2D and ACCORD. The NHLBI carefully reviewed the DSMBs' recommendations and also thoroughly reviewed the recently published meta-analysis of rosiglitazone and the RECORD trial, along with the accompanying editorials published online May 21 and June 5 by the New England Journal of Medicine. "
http://www.nhlbi.nih.gov/new/press/07-rosi-qa.htm
Oh...
The NHLBI concurs with the DSMBs' recommendation that both the BARI 2D and ACCORD data, viewed in the context of the recent publications, contain no observations that would justify a recommendation to terminate rosiglitazone treatment in the research setting of either study.
The New York Times claims that the RECORD study was poorly designed. In fact, the interim RECORD analysis done to follow up on Nissen's claim was had limited statistical power because of an unexpectedly low event rate and incomplete follow-up (a mean of 3.7 years instead of the planned median of 6 years). Still the interim analysis had the same internal statistical reliability as Nissen's analysis: What the Times fails to note is that when Nissen lumped in all 42 studies, he glossed over the fact that the individual studies he looked at were not conducted the same way, with patients with the same disease or drug dose. Further, the 42 studies were small and overall event rates were low, partially because trial durations were relatively short ranging from 24 to 52 weeks, about 25 to 50 percent shorter than RECORD. As anyone who does statistics for a living will tell you, adding up a bunch of underpowered and short term studies does not give you a well-powered study with long term predictive effects.
Here's what one article -- written by Sanjay Kaul and colleagues said about the study: "The investigators' own subgroup analyses, which were limited to the small trials alone or to the 2 large trials (DREAM [Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication] and ADOPT [A Diabetes Outcome Progression Trial]), did not demonstrate statistically significant associations (1). Furthermore, one might reasonably question whether results from the 3 trials that targeted patients with Alzheimer disease (n = 1) or psoriasis (n = 2) who did not have diabetes should be combined with results from other trials that included patients with diabetes or prediabetes. Because rosiglitazone is already contraindicated in patients with heart failure, one might also reasonably limit the assessment of risk to patients without that contraindication and not combine data from the single study in patients with diabetes who had congestive heart failure with data from other studies. Incidentally, this trial exhibited the highest number of myocardial infarctions (n = 5) and cardiovascular deaths (n = 3) among all the small trials in the rosiglitazone treatment group (1).
Read Article
Some people can't handle not being FDA commissioner.... Meanwhile we will keep a running count of the media types who fail to put Nissen, Avandia and other studies about the medicine in context and simply write stories based on the narrative of the insider exposing (once again) the evil drug company.
