The Denver Post

Benefit of Mediterran­ean Diet debunked

- By Samantha Schmidt

Fads in nutrition come and go, but one diet in particular has been widely heralded for its benefits to health — the “Mediterran­ean diet,” rich with vegetables, fruits, fish, nuts and olive oil. For decades, researcher­s have shown that people in Mediterran­ean countries seem to show lower rates of heart disease.

And in 2013, one landmark study gave the strongest proof yet in one of the first major clinical trials to measure the diet’s heart benefits. The study, conducted in Spain, showed that consuming a Mediterran­ean diet can lower the risk of a heart attack, stroke or death from heart disease by about 30 percent in those at high risk.

The five-year experiment, published in the prestigiou­s New England Journal of Medicine, made internatio­nal headlines and was hailed as a triumph.

But on Wednesday, the study’s authors took the rare step of retracting their report. The researcher­s chose to withdraw their original paper and publish a new one after facing criticism of the way the initial experiment was conducted.

The findings of the revised study arrive at the same conclusion­s as the original one — that the Mediterran­ean diet can prevent heart disease. But the language in the new report is a bit more modest.

The original study concluded the diet “resulted in a substantia­l reduction in the risk” of major heart illness among high-risk people, while the new study said “those assigned” to a Mediterran­ean diet had a lower risk than those not assigned.

Despite this softened language in the report, the lead author on the study, Dr. Miguel A. Martínez-González of the University of Navarra, told The Washington Post that the causal link is just as strong as the original report.

“We are now more convinced than ever of the robustness of the trial and of the conclusion­s,” Martinez-Gonzalez said, particular­ly because “no previous trial has undergone such intense scrutiny.”

Still, the retraction and replacemen­t of such a major study in one of the world’s most reputable journals raised eyebrows in the medical world. If the original study was so problemati­c that the authors chose to withdraw it entirely, could the new one be trusted?

“Sad day for credibilit­y of major medical journals and nutritiona­l science,” tweeted Sekar Kathiresan, a physician scientist, human geneticist and director of the Center for Genomic Medicine at Massachuse­tts General Hospital.

The unusual chain of events began with the work of one determined sleuth, a British anesthesio­logist named John Carlisle.

Since the early 2000s, Carlisle and a few others had been noticing red flags in studies published by academic anesthesio­logist Yoshitaka Fujii. Nothing much came of it until about 2009, when Carlisle wrote to the top editor of the journal Anaesthesi­a raising doubt that Fujii’s data was produced by reallife experiment­s.

The issue had to do with randomized controlled trials, which divide participan­ts by chance into separate groups that compare different treatments. Using chance “means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly,” according to the National Institutes of Health.

“If you’re making up data the temptation is to make your groups more similar than what would happen under natural circumstan­ces,” Carlisle told The Washington Post.

Carlisle urged the journal to analyze the data in the Fujii studies, to which the editor responded, “would you mind doing the work?” Carlisle recounted. While he was no statistics expert, Carlisle agreed.

He published a report in the journal Anaesthesi­a in 2012 explaining how and why Fujii’s data was too good to be true. And the medical world took notice. Investigat­ions would later make clear that Fujii had fabricated most of his data. As of 2015, he held the record for most retraction­s by a single author — 183, as Nautilus reported.

In the years since, Carlisle applied the same kind of sleuthing to reports beyond anesthesio­logy. In 2017, he published a report that took a close statistica­l look at 5,087 randomized, controlled trials over a 10year period. His analysis pinpointed, among other things, 11 reports in the New England Journal of Medicine with baseline variables that appeared “almost impossible” to happen randomly, Carlisle said.

Within days, the journal began to review the 11 reports. Of those, only one presented legitimate concerns, the journal said — the 2013 Mediterran­ean diet study. His analysis questioned whether some participan­ts had actually been assigned diets at random.

After Carlisle published his 2017 report, Martínez-González and his team of researcher­s contacted the journal, which urged them to perform a new analysis.

Martínez-González and his team went about reevaluati­ng their data, and found that while some of Carlisle’s findings were “based on mistaken assumption­s,” there were two main problems.

The Mediterran­ean diet trial, which took place at 11 locations in Spain, involved assigning more than 7,000 people at high risk of heart illness to one of three diets: a Mediterran­ean diet supplement­ed with extra-virgin olive oil, a Mediterran­ean diet supplement­ed with mixed nuts, or a simple low-fat diet (the control group).

It turned out that among about 10 percent of the participan­ts, the same diets had been assigned to individual­s in the same household. If a married couple joined the study together, for example, both participan­ts would follow the same diet. For these participan­ts, assignment was therefore not random.

In addition, at one of the 11 study locations, a researcher assigned the same diet to an entire village, which Martínez-González described as a “cluster.”

 ?? Michael Dwyer, The Associated Press ?? On Wednesday, The New England Journal of Medicine retracted and republishe­d a landmark study on the Mediterran­ean diet.
Michael Dwyer, The Associated Press On Wednesday, The New England Journal of Medicine retracted and republishe­d a landmark study on the Mediterran­ean diet.

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