Ah you guys. A mate of mine is a tradie with an interesting...

Ah you guys.

A mate of mine is a tradie with an interesting motto. He aims to disappoint everyone equally.

Some how or other I seemed to have convinced everyone here that I provide a balanced view. I think the trick to this to alternate between positive and negative posts so as to please and disappoint everyone in approximate equal measure. On the plus side I suppose there is an element of randomness that also might add interests.

But in this particular debate it is in fact very easy to find a independent expert opinion expressing concerns about the manner in which those P2 CHF  results were interpreted.

The Editor of Circulation Research commissioned two experts to write an editorial on the P2 CHF results published by Perin.

These experts expressed concerns with respect to the lack of statistical significance with secondary outcomes, no corrections for multiple testing and the post-hoc manner in which the HF-Mace endpoint point was created.

“Perin et al17 conclude that transendocardial injection of these proprietary MPCs is (1) safe and (2) reduces heart failure–related MACE at a dose of 150 milliom MPCs. A concern about this conclusion is that although HF-MACE was compared between each group and against the control with t tests, no correction for multiple comparisons was used. Multiple comparisons were similarly made among the secondary end points and therefore one should be cautious in using these data as primary justification of efficacy. Moreover, as specifically outlined in the study, the HF-MACE end point was generated in a post hoc manner. In the absence of a type I error, one would expect to see other end points, surrogate markers or logical trends toward improvement in other end points that predict heart failure hospitalizations (the majority of HF-MACE events). More specifically, there were no changes in EF, ventricular volumes, BNP, 6-minute walk test, or NYHA class during final end point analysis (6 months for MUGA and single-photon emission computed tomography, and 12 months for all others). A final concern with the interpretation of the data lies in the study design: the control group did not receive any injection of vehicle, PBS, or non-MSC.”

http://circres.ahajournals.org/content/117/6/494.full

On the basis of these concerns the authors (experts) of the editorial concluded that the P3 study had proceeded on the basis of a good safety profile from the P2 trial; not a robust efficacy signal. This quite a bit different to the blue-sky picture painted by MSB about those results.

What is also unusual here is that authors are always given an opportunity to respond to editorials. But in this case Perin et al choose not to. We can also note that other experts have not jumped into the fray in defence of the results.

But look this debate on MSB reminds me of the culture wars during John Howard. The market works in milliseconds. We are debating issues of two years ago which in market time is like 200 years. There has in fact been a bit of stuff that has gone on since captain Cook landed and those results were published.

All the best to all combatants, (hoping to keep my crown of most "balanced" MSB poster for a little while longer) Southoz.