Heart doctors 'held back stent death data'

Heart doctors 'held back stent death data'

2/18/2020

Heart doctors 'held back stent death data'

The trial suggested more people fitted with stents were dying after three years than those given surgery.

These are external links and will open in a new window Close share panel Image copyright Getty Images Doctors working on a clinical trial for treatment of heart disease held back key data, Newsnight has been told. The Excel trial tested whether stents were as effective as open heart surgery at treating patients with a heart problem called left main disease. The data suggested more people fitted with stents were dying after three years. It was eventually published - but only after treatment guidelines that partly relied on the trial had been written. These guidelines recommend both stents and heart surgery for certain patients with left main disease. Trial authors defend standards The authors of the trial said it was carried out rigorously and to accepted academic standards. In the trial, sponsored by US stent manufacturer Abbott, half the patients were given stents, the other half had open heart surgery. Not all the patients were recruited at the same time. Some were recruited in 2011, others over the years that followed. So, when the first results were published in 2016, the doctors doing the trial knew there was data about what had happened to some of the patients five years after their stent or heart surgery procedure. But they chose to look only at what happened up to three years after the patients' procedures and publish that data. A spokesman for Abbott said:"The study's execution, data collection, analysis and interpretation were entirely performed by independent research organisations. The publication of three-year Excel data reflects the original follow-up period and endpoints the study was powered to assess." 'Absolutely appalled' Prof Nick Freemantle, a biostatistician at University College London, said:"If somebody had died three years and one day into the trial, that death wouldn't have been counted in the results. "I'm absolutely appalled that they've done this," he said. "I've taken a straw poll of my professional colleagues and it draws disbelief that people would do this," he said The researchers said the outcomes of the study were analysed and reported according to the protocol. Newsnight has seen information shared between people involved with the safety of the trial that suggested things were starting to look worse for people with stents after three years. More people were dying than those who had had surgery. Emails from the the trial's safety committee warned that all the data about deaths should be viewed by the researchers and published. "It might be very concerning if in the future, suspicions were raised that already available information on mortality was withheld from the cardiology and thoracic surgery community," Dr Lars Wallentin, the head of the safety committee, wrote to the researchers in 2017. He was worried that major European clinical guidelines were being drawn up by heart doctors about how people with left main disease should be treated and the trial results would be used as part of their work. But the doctors on the trial chose not to publish the data when the safety committee asked, despite the warning. They published further data after the guidelines were completed. Even without this additional data, there was disagreement among those writing the guidelines about whether stents or surgery was the better treatment for patients. Review 'not shared' An external reviewer was brought in by the European Society of Cardiology to look at a number of trials and resolve the debate. Newsnight has seen the review. It said that the evidence suggested stents were worse than surgery for those with left main disease. "I think most patients would find these differences to be clinically meaningful, I do not believe that both these procedures should receive the same class of recommendation," it said. But the review was not shared with everyone who believed they should have seen it. One of those people was Prof Freemantle, who was involved in the European guidelines. He claims that this calls into question the neutrality of the whole process. Image caption Stents are a less invasive option than open heart surgery Newsnight has previously reported that the same trial failed to publish certain heart attack data that cast stents in a bad light. The researchers said our leak data was fake and their methodology was the right one. Following Newsnight's previous report, a number of major surgical organisations have called for a review of the trial. The researchers carrying out the trial have agreed to an"independent" review of the raw data. Various names have been put forward by the researchers and the European Society of Cardiology about who is doing the analysis. All have ties to the researchers, guidelines process or medical device industry. When approached by the BBC they have all said they are not doing it. No ties Prof John Ioannadis, from Stanford University, an expert on medical research design, said the analysis must be completely independent. "I think that if you have the same network, the same closed club passing the data from one member to another, that's not really very helpful," he said. He believes the trial and guidelines process raise concerns which are indicative of a wider systemic problem with the way medical research is done. All the main doctors working on the trial, and the lead doctor writing the guidelines for left main disease, have declared financial contributions to either themselves or their institutions from companies that manufacture stents. "You have the same people who run the show at all levels. They design the trials. They set the agenda, they choose what to present. "They are involved in disseminating the information and running the large conferences that are attended by tens of thousands of people, specialists in the field. And then they also populate the guideline panels that reach the recommendations," he said. The organisations involved and researchers have declared the conflicts of interest, and say that they are effective in managing them. The conflict-of-interest declarations are intended to mitigate against conscious or unconscious bias - or the appearance of it. You can watch Newsnight on BBC Two at 22:30 on weekdays. Catch up on iPlayer, subscribe to the programme on YouTube and follow it on Twitter. Related Topics Read more: BBC News (UK)

May 2018 Cardiac arrest 2 stents Dec 2018 Cardiac MRI all clear July 2019 Cardiac arrest, 1 stent completely the other stent blocked with still flow. August 2019 triple by Pass Stents lasted 14 months- how can that be.? VictorDayan1 Wow! odibro $Corv squuZe lets gooo ugly. You are already broken. Everyone looks at me. I look at you.

You just a one mistake. More worries for those fitted with stents following heart attacks. Rasoul_D heart doctors errjustsaying Publication bias destroys the usefulness of statistics. It's true in clinical trials, and also in climate change 'science'.

12 amazing acts of kindness that will warm your heart12 amazing acts of kindness that will warm your heart RandomActsOfKindnessDay Thank you for this! Got a lump in my throat. Well done everyone.

Heart stopping admission Too much pressure upon all researchers, incl. those in medicine, to publish only favorable results & to conceal unfavorable ones. Shame! Revealing interview with Oxford psychologist Dorothy Bishop, “The reproducibility crisis”. Video on Youtube. I was told I may need a stent by one cardiologist but whe I moved my care due to relocating I was told no way would I have a stent in as that would be less ideal than open heart surgery, so my current cardiologist knows it isn't safe I would say and refused to give me one.

Nonsense, the men in which coats would NEVER do such a thing ... 🙃 Most side effects of procedures and medications are held back from the public! The research was paid for by the stent manufacturer. The only unusual thing about this case is that the corruption’s been made public

Wake up, mummy: Heart-breaking moment monkey tries to stir dead parentA baby Golden Langur monkey tried in vain to rouse its dead mother after she collapsed at around 3pm on Wednesday, near the Kakoijana forest by the city of Bongaigaon, Assam. Oh no poor creatures THAT IS NOT RIGHT TO DO THAT TO ANY ANIMAL ON EARTH.🧐 ¡¡La maldita humanidad!!

Wake up, mummy: Heart-breaking moment monkey tries to stir dead parentA baby Golden Langur monkey tried in vain to rouse its dead mother after she collapsed at around 3pm on Wednesday, near the Kakoijana forest by the city of Bongaigaon, Assam. Heartbreaking No way I’m watching that So sad. Also when deer are killed, bears are killed, lions, tigers, birds, etc. are killed, their offspring suffer too. Shooting for pleasure hunting or 'sport' must be banned worldwide

Wake up, mummy: Heart-breaking moment monkey tries to stir dead parentA baby Golden Langur monkey tried in vain to rouse its dead mother after she collapsed at around 3pm on Wednesday, near the Kakoijana forest by the city of Bongaigaon, Assam. 😞 Hmmm life oh your mom is gone, this picture clearly shows the demise of Nigerian centralised economy.

Russian lieutenant proposes by arranging 16 tanks into heart shapePlatoon commander Denis Kazantsev paused war games on Valentine's Day and ordered the T-72B2 tanks to make the romantic shape at the Alybino training ground, near Moscow. Romance on the Taxpayer. Not sure a Brit Officer would get way with such a romantic gesture The most Russian thing ever... Tough love!

Girl, 18, dies from 'massive' heart attack during sleepover after night outMassive Liverpool FC and music fan, Sinead Maguire, 18, suffered a heart attack following a night out and died - but her family are still waiting for a coroner's report to explain exactly what happened Beautiful girl, RIP 💔 😰🙏🌹



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