Raw Data

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Doctors work in a clinical research study for the treatment of heart disease held back-button, data, Newsnight has been said.

The Excel study tested whether the stents were as effective as open-heart surgery in the treatment of patients with a heart problem called left main disease.

proposed to The data, more people, equipped with a stent, died after three years.

It was finally released, But only after treatment guidelines, based in part on the study had written.

These guidelines recommend the two stents and open-heart surgery in certain patients with left main disease.

the authors of The study said that it was carried out in a consistent and accepted scientific standards.

In the study, sponsored by Abbott's U.S. stent manufacturer, half of the patients received stents, The Other half had open-heart surgery.

were Not recruited all patients, at the same time. Some were recruited in the year 2011, The Other in the course of The Years that followed.

So, when The First results were published, in the year 2016, The Doctors doing the study knew that it is data about what had happened, some of the patients five years after stent or heart surgery procedures.

But you just wanted to see what happened, up to three years after the patient's procedure, and the publication of this data.

A spokesman for Abbott, The study implementation, data collection, said: ", - analysis and interpretation have been fully carried out by independent research institutions. The publication of the three-year-Excel-data refer to the original follow-up period and endpoints the study was powered to assess. "

'Absolutely

Professor Nick Freemantle, a biostatistician at the University College London, said horrified': "If someone had died, three years and One Day in the study that the death would not have been counted, the results.

"I am absolutely appalled that you have done this," he said.

"I have a survey for my professional colleagues, and it attracts incredulous people would do," he said.

the researchers said, the results of The study were analyzed and reported according to the Protocol.

Newsnight has seen the exchange of information between individuals, which suggested the safety of the study that things started to look worse for people with stents after three years. More people died than those who had surgery.

E-Mails that warned the process of the Committee for security, all data on deaths should be by the researchers and published.

"It would be very worrying, if in The Future , a conjecture expressed were that there is already available information on mortality was held back by the cardiology cardiothoracic surgery community," says Dr. Lars Wallentin, Director of the Committee for security, the researchers wrote in the year 2017.

He was worried that the large European clinical guidelines have been developed by the heart doctors about how people should be treated with left main disease and the study, would the results be used as part of their work.

decided not to But The Doctors on the study, publish the data, if the safety Committee asked, in spite of The Warning . She has published more data have been completed according to the guidelines.

Even without these additional data, there was disagreement among those who write the guidelines to the question of whether a stent or surgery was the better treatment for the patients.

An external expert of the European society of cardiology views, A Number of studies and resolve The Debate .

Newsnight review. He said that the findings suggest, stents were worse than surgery for people with left main disease.

"I don't think most patients would be important to find these differences to be clinically, I believe that these two procedures should be the same class of the recommendation," it said.

But the evaluation was not shared with any who believed that they should have seen it. One of these people, Prof Freemantle, who was involved in the European directives.

He claims that this calls into question the neutrality of the whole process.

Newsnight has previously reported that the same attempt failed, and certain heart-attack data, the cast stent in a bad light.

The researchers said, our leak data was wrong, and their methodology was The Right one.

the Following Newsnight earlier report was a series of major surgical organizations have the version for a review of the test.

The researchers conducting the study have agreed to an "independent" evaluation of the Raw Data .

Various names have been suggested by the researchers and of the European society of cardiology on the work of the analysis. All have ties to the researchers, guidelines, process, or medical products industry.

after he make of the BBC, they have all said it.

No ties

Prof John Ioannadis, from Stanford University , an expert on medical research, said the analysis must be completely independent.

"I think that if he said the same network, the same closed club not to pass the data from one member to another, this is really very helpful".

He believes that the study and guidelines-process raise the question, what are the signs of a system done is a problem with the way medical research.

Stents are less invasive than open-heart surgery

All of the important doctors on the study, and the senior doctor to write the guidelines for left main disease, have stated that financial contributions to either yourself or your organs of company, the manufacture of stents.

"the same people who run The Show on all levels. You make the tests. You set The Agenda , you decide what you are presenting.

"are you involved in the dissemination of information and the execution of large conferences, which are attended by tens of thousands of people, specialists in The Field . And Then they will complete the guideline panels that reach the recommendations," he said.

The participating organisations and researchers have declared that conflicts of interest, and say that they are effective in the management. The conflict-of-interest are explanations mitigate intended, to, against conscious or unconscious bias - or the appearance of it.

Newsnight can watch on Bbc Two from 22:30. Catch-up on iPlayer, to subscribe to the program on YouTube and follow her on Twitter .

Source of news: bbc.com