> Newsnight has seen that unpublished data and it shows that under the universal definition, patients in the trial that had received stents had 80% more heart attacks than those who had open heart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.
Ouch. What do you get when you mix healthcare and a profit-driven capitalist mentality where no one in the industry (the corporations, not talking about doctors) actually cares about saving lives? Crap like this.
This stuff makes me so furious. It's not okay to play with the lives of others just to drive profits.
----------
> The trial called Excel started in 2010 and was sponsored by big US stent maker, Abbott.
> 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.
> In the course of the investigation, Newsnight found a larger debate within the medical community about the way that conflicts of interest are handled.
> There is one school of thought that says they raise questions and need to be carefully managed because of potential bias - conscious or unconscious.
> Others say that interactions between research and business are vital and there is a real public good to be gained by them.
Uhm. "Interactions". Sure. Lots of public good was gained from this study and the following guidelines that were adopted, eh? Ridiculous.
> Ouch. What do you get when you mix healthcare and a profit-driven capitalist mentality where no one in the industry (the corporations, not talking about doctors) actually cares about saving lives? Crap like this.
I just want to share this opinion from what you wrote. The mentality that "people go into certain careers for moral reasons" needs to go out of fashion. Even in non-capitalist societies people should never consider the belief that people enter careers for moral reasons as true.
The reason is that the careers/fields most important for the health of society, need to function correctly in any case and by a system that's designed for even if we're all sociopaths.
I get your point, but is it always possible? Sometimes you have to trust people and take the downside. For example, I think academia worked better when researchers were allowed to just go on with it, knowing that a certain percentage wouldn’t work very hard or do things that weren’t very useful.
> Even in non-capitalist societies people should never consider the belief that people enter careers for moral reasons as true. [...] The reason is that the careers/fields most important for the health of society, need to function correctly in any case and by a system that's designed for even if we're all sociopaths.
Nope; such a cynical approach that doesn't lead to healthy outcomes. What you're saying flies in the face of millenia of accumulated wisdom on human development. It is definitely a subject with tons of nuance, but in essence humans are malleable, and do respond to expectations/environment. To quote Geothe (as popularly paraphrased by Victor Frankl): “If you treat an individual as he is, he will remain how he is. But if you treat him as if he were what he ought to be and could be, he will become what he ought to be and could be.”
For those seeking a broader and more holistic outlook on the moral dimension of people's activity, especially work, I recommend Barry Schwartz's talks/writings eg: talks on "The way we think about work is broken", "Doing the right thing for the right reason", and on practical wisdom available on YouTube.
The position that there even is a coherent "millennia of accumulated wisdom on human development" is at best a spurious one. The next position would be "can we easily draw from it" - which is unlikely, even given ready access to all of the surviving literature (such as it is).
Sure, but those values are not always the noble idea of wanting to help people. There are a lot of egotistical social misfits with temper problems who are operating on us. Some of them are very good at it. Some of them are less good.
There were probably ~500k people worldwide impacted by this guidance. There will be at least 10k+ people dead now compared to if this study had come to the opposite conclusion.
And all that so the principal investigator could get another few thousand dollars.
Lesson: If you're going to murder tens of thousands of people, at least be properly compensated for it!
> This year the trial published a further set of its results, showing what had happened to the patients five years after their treatment.
> This found for every 100 who died after having open heart surgery, 135 people with stents died. Overall, 10% of people who had surgery died in the trial compared with 13% who had stents
I don’t know enough about other aspects of the surgery, but if it’s just a small percentage point difference, and we are talking about a choice between minimally invasive vs weeks of recuperation and pain, I’d think twice about it.
>Second potential bias is possibly how many patients continued with "bad behaviours" after the surgery vs. the stent.
My understanding is that open heart surgical intervention is much more effective at inducing behavior change.
If so, what does that imply that cardiologists should recommend? Should a more invasive procedure be used, simply for the fact it is more invasive? Should the stenting procedure be made more painful?
Compliance is the biggest challenge w.r.t. becoming healthier. You need either a really compelling reward at the end, or a severe enough punishment to enforce compliance.
I don't know about that (meaning I really don't know, not that I think you're wrong). I know that a lot of time (and money) in nursing and hospital policy is aimed at the huge problem of patient compliance and what can be done to increase it. And I wouldn't doubt for a minute that insurance companies wouldn't love to "influence" policies toward lower-cost interventions using compliance issues as their leverage.
Those are very abstract, I didn't start watching my sugar intake until a close relative got diabetes, despite the fact I had distant relatives with the disease, I saw it every day, and I consciously understood that it was something to avoid. Unfortunately people don't "get" things until they are too close to avoid, a lot of the time.
The problem is that the feedback from the behaviour is not immediate. This is ultimately why it is not easy to be disciplined about a lot of things for which the results are only apparent after a long time. There is no easy way.
Typically heart patients stick to Dr orders according to numerous people on my cardiac team. Kidney patients are apparently the worst with a very YOLO attitude
As I posted earlier. It's not weeks. It's your life regardless of surgery. Im 37 and have it. I would absolutely take the risk if it improved my quality of life. Sign me up tomorrow.
Fair criticism, but I think the point is the public is being mislead to believe that they are equal in all aspects so you should always pick the stent because it is so less invasive.
Personally, 10% vs 13% of overall people who were in the trial is significant and would give me pause. I would trade pain and recuperation for 3% less mortality.
I'd definitely have a safe but painful surgery for a condition that has a 3% chance of killing me if untreated. I'd also have surgery that had a 3% chance of success for an otherwise terminal condition (if I could find a surgeon willing to operate...)
But 10% vs 13% doesn't feel as significant to me. Maybe this is irrational.
I don't think it's irrational at all. It's risk tolerance.
For myself, I believe the pain and anguish is worth the 3%, given all other things equal. Others like yourself, might not.
Maybe I'm the irrational one.
At the end of the day, the point of the article is exactly that - so you can make an informed decision.
I choose to have my 3% back; You get less pain/recovery.
Pre whistleblowing, there was no choice. It was stent 100% and, oversimplified, 3% more people died without having gotten to make that choice because the study was funded by the stent guys. It was decided for them.
Results like this are hard to interpret locally. Anything that gets you out of the hospital more quickly is worthwhile... there are any number of hazards in the hospital that are best avoided.
>I would trade pain and recuperation for 3% less mortality.
May not only be pain, a relative had open heart surgery and can’t read anymore. Some risk of permanent brain and/or lung damage from surgery itself from strokes or pulmonary embolism (although not sure how that compares long term to stents).
I’d also take into account the percent of remaining life expectancy the recovery period takes up (although if it’s a few months that’s probably less than 3%).
Most worrying was another comment pointed out that lifestyle changes take better in the open heart surgery patients. Dietary intervention is effective for heart disease but most people can’t follow through. So it seems very plausible that some or all of the benefit (or even more than all) could come from essentially torturing people enough to scare them into making a lifestyle change. Which is still a real effect I guess, but some people may be capable of following through without that.
I'm not sure if you meant that you would take the surgery or not. But Heart disease isn't a few weeks of recuperation. It's life. I'm at 25 percent after 8 months. I'll never be above 70 percent. I'd roll the dice and take the surgery. I'm already getting an implant in two weeks which is slightly beyond experimental but definitely not wide spread.
No, this is completely different. This is a patient group that needs interventions, and the focus of the investigation and the controversy is about the type of intervention... A small stent or a large bypass.
There's not a lot of discussion of confounding factors in popular media, but I wonder what the distribution is of people who get open heart surgery vs. people who have stents installed? If stents are considered less invasive and risky then maybe they're recommended more to people who are otherwise too sick to have heart surgery (and obviously have a higher subsequent rate of death)?
The study selected people that were good candidates for the stents and randomly assigned them to the treatment groups.
There's a built in presumption there that they are eligible for the surgery.
Which you are basically saying, is there a patient group where stents make sense even in the light of this evidence, and that's fine, I just wanted to make it clear that the study was randomized.
Since 2016 there must have been 10s of thousands of stents placed and 10s of thousands of surgeries.
What has been the actual results of following the recommendation? What percentage of each have had recurring heart attacks, second procedures, or died?
Why do we have all these electronic health records if we aren't using them?
True, but it would reflect real experiences of patients having the respective procedures done under normal conditions by ordinary surgeons, rather than under trial conditions. If there is a big difference in real world clinical outcomes, it would be evidence for the need for a new study.
The 2016 report is free (including supplementary appendix) at https://www.nejm.org/doi/10.1056/NEJMoa1610227 The appendix includes an extensive list of trial participants and institutions. It was a global study.
>Newsnight has seen that unpublished data and it shows (...)
> Prof Rod Stables (...) 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".
>Prof Nick Freemantle worked on the guidelines. He told Newsnight he would "never" have agreed the treatments were interchangeable if he had seen the leaked data.
This is becoming too common to be ignored: sugar coating scientific production so that they are unreproducible, is purely misleading, or the conclusions would be different if some data didn't hold back.Of course, adding health, conflict of interest (despite it being warned in the article) and industry just makes things more dangerous, but the essence is the same: more scientific papers being published each year don't mean more quality, nor that we are making all the progress we think.
Another example of evidence based medicine changing things is PSA testing and "digital rectal exams" performed in the US routinely for middle-aged men over 40 for decades. No evidence supporting these a routine procedure. Many other countries never did that because there was no reason to do so. Butt fingering and PSA test has been a money maker for doctors.
Medicine is unlike engineering or law or anything else really.
Engineering is problem-solving.
Law is precedent arguing.
Medicine is process-driven, almost 100%. There's a correct (currently approved) way to approach each procedure. Practitioners have memorized thousands of them. They regularly review (in a sad weekend in a holiday inn meeting room with a dim projector and droning presenter) to keep their license current.
Agreed at the point of problem-solving (diagnosis) they've got muddy data and a few diagnostic decision-trees to follow. So they appear to be biased or opinionated.
There is also doing the most good for most people. For every person who dies due to a misdiagnosed disease, there are 10,000 that were properly diagnosed with the less dangerous, cheaper to test for, and massively more likely illness. It would be irresponsible to take that decision tree to the farthest branch when it is almost certainly something simple.
I definitely feel for people doing diagnostics in this profession, you can't be right all the time. If you try, you're highly irresponsible.
I would pick the stent 100% of the time despite the 1/3 more mortality; I live alone and cannot recover for months by myself. If you have a family member willing to care for you for months then picking the other choice is probably worth the effort. Of course in the end you have a 100% chance of dying anyway. Perhaps quality of life while you are living is worth more than living terrible for part of it. But knowing the actual risk/reward is what is important.
You also left out "Unusual definition of a heart attack".
> The trial called Excel started in 2010 and was sponsored by big US stent maker, Abbott.
> It was led by eminent US doctor Gregg Stone and aimed to recruit 2,000 patients. Half were given stents and the other half open heart surgery.
> Success of the treatments was measured by adding together the number of patients that had heart attacks, strokes, or had died.
> 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. There is debate around which is a better measure and the investigators stand by their choice
I had a coronary artery bypass graft earlier this year so I can offer some perspective on recovery. I wasn't eligible for stents due to the extent of the blockages.
Recovery is painful. The sternum is sawn in half to access the heart, I am 9 months out and my sternum still hurts.
Aside from the pain it is not bad. I was walking the day after the surgery. I was discharged in 4 days. I was back at work full time in 2 weeks. I was able to run a mile within a few months.
I was in cardiac rehab with patients who had received stents. They seemed to progress slower because many of them still had angina. They had a minimally invasive procedure, but they still had chest pain when exerting themselves.
51 comments
[ 3.1 ms ] story [ 122 ms ] threadOuch. What do you get when you mix healthcare and a profit-driven capitalist mentality where no one in the industry (the corporations, not talking about doctors) actually cares about saving lives? Crap like this.
This stuff makes me so furious. It's not okay to play with the lives of others just to drive profits.
----------
> The trial called Excel started in 2010 and was sponsored by big US stent maker, Abbott.
> 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.
> In the course of the investigation, Newsnight found a larger debate within the medical community about the way that conflicts of interest are handled.
> There is one school of thought that says they raise questions and need to be carefully managed because of potential bias - conscious or unconscious.
> Others say that interactions between research and business are vital and there is a real public good to be gained by them.
Uhm. "Interactions". Sure. Lots of public good was gained from this study and the following guidelines that were adopted, eh? Ridiculous.
I just want to share this opinion from what you wrote. The mentality that "people go into certain careers for moral reasons" needs to go out of fashion. Even in non-capitalist societies people should never consider the belief that people enter careers for moral reasons as true.
The reason is that the careers/fields most important for the health of society, need to function correctly in any case and by a system that's designed for even if we're all sociopaths.
Nope; such a cynical approach that doesn't lead to healthy outcomes. What you're saying flies in the face of millenia of accumulated wisdom on human development. It is definitely a subject with tons of nuance, but in essence humans are malleable, and do respond to expectations/environment. To quote Geothe (as popularly paraphrased by Victor Frankl): “If you treat an individual as he is, he will remain how he is. But if you treat him as if he were what he ought to be and could be, he will become what he ought to be and could be.”
For those seeking a broader and more holistic outlook on the moral dimension of people's activity, especially work, I recommend Barry Schwartz's talks/writings eg: talks on "The way we think about work is broken", "Doing the right thing for the right reason", and on practical wisdom available on YouTube.
And all that so the principal investigator could get another few thousand dollars.
Lesson: If you're going to murder tens of thousands of people, at least be properly compensated for it!
> This found for every 100 who died after having open heart surgery, 135 people with stents died. Overall, 10% of people who had surgery died in the trial compared with 13% who had stents
I don’t know enough about other aspects of the surgery, but if it’s just a small percentage point difference, and we are talking about a choice between minimally invasive vs weeks of recuperation and pain, I’d think twice about it.
This is an important aspect.
Is the study considering the mortality of the surgery itself? It seems so, but nonetheless it is not a simple procedure.
Second potential bias is possibly how many patients continued with "bad behaviours" after the surgery vs. the stent.
My understanding is that open heart surgical intervention is much more effective at inducing behavior change.
If so, what does that imply that cardiologists should recommend? Should a more invasive procedure be used, simply for the fact it is more invasive? Should the stenting procedure be made more painful?
Maybe we should just cane people for eating high-cholesterol diets? Safer than either surgical option! /s
A terribly severe punishment: Death
I don’t think we can really improve upon these to be honest...
The point here is that they say that surgery has actually a higher survival rate than stents.
Personally, 10% vs 13% of overall people who were in the trial is significant and would give me pause. I would trade pain and recuperation for 3% less mortality.
But 10% vs 13% doesn't feel as significant to me. Maybe this is irrational.
I would personally think a 3% difference in overal mortality is certainly worth a little while recovering.
For myself, I believe the pain and anguish is worth the 3%, given all other things equal. Others like yourself, might not.
Maybe I'm the irrational one.
At the end of the day, the point of the article is exactly that - so you can make an informed decision.
I choose to have my 3% back; You get less pain/recovery.
Pre whistleblowing, there was no choice. It was stent 100% and, oversimplified, 3% more people died without having gotten to make that choice because the study was funded by the stent guys. It was decided for them.
May not only be pain, a relative had open heart surgery and can’t read anymore. Some risk of permanent brain and/or lung damage from surgery itself from strokes or pulmonary embolism (although not sure how that compares long term to stents).
I’d also take into account the percent of remaining life expectancy the recovery period takes up (although if it’s a few months that’s probably less than 3%).
Most worrying was another comment pointed out that lifestyle changes take better in the open heart surgery patients. Dietary intervention is effective for heart disease but most people can’t follow through. So it seems very plausible that some or all of the benefit (or even more than all) could come from essentially torturing people enough to scare them into making a lifestyle change. Which is still a real effect I guess, but some people may be capable of following through without that.
Surgeons only get paid if they do surgery, it feels like this is the first option I'm offered when there is a problem.
So far "waiting" saved us 2000 dollars.
There's a built in presumption there that they are eligible for the surgery.
Which you are basically saying, is there a patient group where stents make sense even in the light of this evidence, and that's fine, I just wanted to make it clear that the study was randomized.
What has been the actual results of following the recommendation? What percentage of each have had recurring heart attacks, second procedures, or died?
Why do we have all these electronic health records if we aren't using them?
The 2016 report is free (including supplementary appendix) at https://www.nejm.org/doi/10.1056/NEJMoa1610227 The appendix includes an extensive list of trial participants and institutions. It was a global study.
The 2019 report with 5-year outcomes is at https://www.nejm.org/doi/10.1056/NEJMoa1909406
> Prof Rod Stables (...) 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".
>Prof Nick Freemantle worked on the guidelines. He told Newsnight he would "never" have agreed the treatments were interchangeable if he had seen the leaked data.
This is becoming too common to be ignored: sugar coating scientific production so that they are unreproducible, is purely misleading, or the conclusions would be different if some data didn't hold back.Of course, adding health, conflict of interest (despite it being warned in the article) and industry just makes things more dangerous, but the essence is the same: more scientific papers being published each year don't mean more quality, nor that we are making all the progress we think.
https://www.forbes.com/sites/stevensalzberg/2013/11/11/great...
Each physician is a biased opinion provider.
It's up to YOU to figure out who is correct.
Horrifying this is needed and they make 300k/yr.
Engineering is problem-solving.
Law is precedent arguing.
Medicine is process-driven, almost 100%. There's a correct (currently approved) way to approach each procedure. Practitioners have memorized thousands of them. They regularly review (in a sad weekend in a holiday inn meeting room with a dim projector and droning presenter) to keep their license current.
Agreed at the point of problem-solving (diagnosis) they've got muddy data and a few diagnostic decision-trees to follow. So they appear to be biased or opinionated.
I definitely feel for people doing diagnostics in this profession, you can't be right all the time. If you try, you're highly irresponsible.
Or moms who have their kids go vegan (with essential oils for extra help!).
> The trial called Excel started in 2010 and was sponsored by big US stent maker, Abbott.
> It was led by eminent US doctor Gregg Stone and aimed to recruit 2,000 patients. Half were given stents and the other half open heart surgery.
> Success of the treatments was measured by adding together the number of patients that had heart attacks, strokes, or had died.
> 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. There is debate around which is a better measure and the investigators stand by their choice
Recovery is painful. The sternum is sawn in half to access the heart, I am 9 months out and my sternum still hurts.
Aside from the pain it is not bad. I was walking the day after the surgery. I was discharged in 4 days. I was back at work full time in 2 weeks. I was able to run a mile within a few months.
I was in cardiac rehab with patients who had received stents. They seemed to progress slower because many of them still had angina. They had a minimally invasive procedure, but they still had chest pain when exerting themselves.
If I had to do it again I would pick a CABG %100