Can You Test A Drug And Also Say Negative Things About It? 8

In my last post I raised the possibility that Steve Nissen, a highly influential cardiologist who has been an outspoken critic of industry influence in medicine, might have his own conflict of interest (COI) problem. In response, another cardiologist, James Stein, said that my post was unfair in its treatment of Nissen and failed to consider important distinctions and subtleties in the academic literature about conflict of interest.

Let me first of all confess that Stein– for whom I have the highest possible regard– makes some excellent points. And I further admit that my piece pretty much ignored some of these fine academic distinctions. But I also think it’s likely that we may have a forest and trees situation here and that by focusing on subtle COI distinctions it is possible to lose sight of the larger issue.

A Simple Test

Rather than focus on the subtle distinctions between different types of COI I’d like to propose a much simpler way to think about this problem as it exists in the real world. Here’s the test I would propose: can you imagine Nissen, or indeed anyone in a similar situation (running a large multimillion dollar trial of a drug) publicly saying something decidedly negative or critical about the drug?

Click here to continue reading…

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Diet Drug Study Crashes And Burns In The Wake Of Leaked Results Reply

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early interim analysis of the study.

The news about the trial was announced in a press release from the companies and a press release from the Cleveland Clinic, the home institution of Steve Nissen, the trial’s chairman.

Click here to read the full post on Forbes.

 

Previous Coverage:

Steven Nissen (AP Photo/Judi Bottoni)

With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial Reply

 

The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed by the Duke Clinical Research Institute (DCRI) confirmed the initial finding of the trial that rosiglitazone was not associated with an increased risk for cardiovascular events.

 

For the most part, the FDA documents released today express strong support for the DCRI re-adjudication. But one FDA official, Thomas Marciniak, remains highly critical of RECORD  and says the trial data and, therefore, the analysis of the data from GSK and DCRI are completely unreliable. All parties agree, however, that the fundamental underlying design flaws of RECORD–  in particular, it’s open-label design– mean that data from the trial will never provide definitive assurance about the safety of rosiglitazone.

 

One FDA reviewer said the DCRI review of the mortality results in RECORD was “well-conceived and comprehensive” and “no stone was left unturned.” But the same reviewer states:

 

There is no amount of analytical rigor that can compensate for a weak trial design that is exacerbated by elements of poor execution, both of which afflicted RECORD. Its open- label non-inferiority design was simply problematic, especially for ascertainment of non-mortality MACE during trial execution…. Thus, while we agree with the analytical findings of the DCRI mortality re-analysis, we would emphasize that RECORD’s design irreparably hampers its ability to characterize definitively the CV risk of rosiglitazone.

 

The panel may well accept the findings of the re-adjudication and the FDA analysis. In that case the terrifying specter looming over the FDA and the rest of the medical establishment– that not just rosiglitazone but the entire drug development and approval process was fundamentally flawed and unreliable– will be put to rest, at least for now.

 

A Bitter Feud

 

Buried in the massive document is a bitter feud between an FDA rebel, Thomas Marciniak, and his bosses and other senior officials in the FDA’s drug division….

Click here to read the full story on Forbes.

 

Fda

 

This Week In Medicine: Stop Exercising and Eat Chocolate! 5

It’s been a terrific few days of medical news for lazy people and chocoholics.

First, a study in PLoS One provided ammunition to the exercise-averse crowd by claiming that exercise can actually be bad for some healthy people. As an added bonus, a story about the study was carried on the front page of the New York Times.

Less than a day later, in a moment that will be long treasured by chocoholics, a study in BMJ calculated that people with metabolic syndrome could reduce their risk of serious cardiovascular events like heart attacks and strokes by eating dar chocolate every day.

Let’s take a quick look at each study:

The exercise study used data from 1,687 people who participated in one of six different exercise studies and found that a surprisingly large percentage of people had a significant adverse change in one of several important risk factors:
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CT Angiography Found Less Helpful in Patients With High Calcium Scores Reply

Computed tomography angiography (CTA) has been proposed as a less invasive method to exclude obstructive coronary artery disease (CAD), but no consensus has been achieved about its clinical role in different patient subsets. Now a new report published in JACC from the CORE-64 (Coronary Artery Evaluation Using 64-Row Multidetector Computed Tomography Angiography) study shows that CTA may not be worthwhile in people with a calcium score of 600 or above or who already have a high pre-test probability of having CAD.
Click to continue reading…