Surgeons withdraw support for heart disease advice

TiredSam

Committee Member
From the BBC website. This story contains a lot of familiar elements:

In the Excel trial, the four main investigators all declared conflicts of interest.

Lead investigator Prof Gregg Stone declared he had received personal fees or held equity in 20 private medical companies, several of which made tools that helped with putting in stents.

He's also the course director for TCT, an annual medical conference where the results were presented.

TCT makes money from exhibitors including some of the biggest stent makers - Abbott, who sponsored the trial, Boston Scientific and Medtronic.

Prof Pieter Kappetein, who worked on the trial and on the body that worked on the guidelines, declared that he had left the guidelines body to go and work for Medtronic, a medical device manufacturer that makes stents.

Newsnight found that he'd become chief medical officer of Medtronic Structural Heart.

By Newsnight's count, around half of the investigators on the trial had declared personal fees from companies that made stents, and around a third of those on the taskforce writing the guidelines.

https://www.bbc.com/news/health-50715156

If this kind of story becomes a thing, we've got the ultimate example for any journalist who's interested ...
 
It does sound familiar:
The research team used an unusual definition of a heart attack, but had said that they would also publish data for the more common "Universal" definition of a heart attack alongside it. [...] But researchers had failed to publish data for the common, "Universal" definition of a heart attack. Newsnight has seen that unpublished data and it shows that under the universal definition, patients in the trial that had received stents had 80% more heart attacks than those who had open heart surgery. [...] Prof Rod Stables, clinical lead for research at the British Heart Foundation, said this information should have been published and knowing it would have made a "substantial contribution to our ability to appreciate the nuances of the results".
 
It's on YouTube.

"Once you say you are going to measure something in a clinical trial you are expected to publish it"



Deborah Cohen
Deborah is an award winning medically qualified freelance TV, print and radio reporter and editor.

As well as writing and editing, she has reported and co-produced TV and radio documentaries and acted as a consultant to other journalists globally.
https://www.drdeborahcohen.com/contact/

Also ex investigations editor at BMJ latest. According to twitter.
https://twitter.com/deb_cohen?s=09
 
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EACTS responds to BBC Newsnight’s investigation on the EXCEL trial


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EACTS responds to BBC Newsnight’s investigation on the EXCEL trial
Following BBC Newsnight’s investigation, Professor Domenico Pagano, Secretary General of EACTS, says:

“The Council of the European Association for Cardiothoracic Surgery (EACTS) has considered the analysis of the data that BBC Newsnight has shown us. It is a matter of serious concern to us that some results in the EXCEL trial appear to have been concealed and that some patients may therefore have received the wrong clinical advice.

“Following the information presented to us by Newsnight, the EACTS Council has unanimously decided, with immediate effect, to withdraw our support for the Left Main Chapter of the joint 2018 EACTS-ESC (European Association for Cardiothoracic Surgery and European Society of Cardiology) Clinical Guidelines for Myocardial Revascularisation. If the information on the trial is proven to be correct, the recommendation is unsafe. On behalf of the EACTS Council I have written to the ESC to invite them to work with us to develop a new joint section of the guidelines as a matter of urgency.
https://www.eacts.org/eacts-responds-to-bbc-newsnights-investigation-on-the-excel-trial/

[found this on MS twitter feed .....]

eta: MS take note
 
Oh, are those things bad? Conflicts of interest, heavy bias, paid employment based on promoting those same results, misrepresenting results, boasting of success despite "no difference in outcomes", using invalid definitions? Those are bad now? Generally? Or just in this specific case? Is this a new thing? Or an optional requirement?

Because they sure are dismissed as inconsequential when it comes to us so it's very hard to make sense of what is allowed and how or why requirements become optional for some. Maybe they should have used only subjective outcomes midway during trial while removing all objective outcomes. Everything is permitted when you do that.

Have they tried explaining that they just preferred the results and giving assurances that their deviations did not impact showing positive results despite there being no evidence of those? Or maybe they should have founded a company built on promoting their treatment model during their flagship trial. That usually works out. Well, maybe not generally but it sure does sometimes when nothing else does.
 
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"Once you say you are going to measure something in a clinical trial you are expected to publish it"
* unless you "prefer the results" if you do otherwise, obviously, then just give assurances that it's just a coincidence that the results are much better this way**

** do not attempt without significant political influence to retroactively clear of any issues such as "ethics" and "requirements" or fringe concepts such as "rules"
 
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