Clearing Away the Rubbish

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue”
~Richard Horton, editor in chief of The Lancet

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor”
~Dr. Marcia Angell, former editor in chief of NEJM

Back in September, there was a scientific paper published in Clinical Cardiology, a peer reviewed medical journal that is “an official journal of the American Society for Preventive Cardiology” (Wikipedia). It got a ton of attention from news media, social media, and the blogosphere. The reason for all the attention is that, in the conclusion, the authors claimed that low-carb diets had proven the least healthy over a year period:

“One-year lowered-carbohydrate diet significantly increases cardiovascular risks, while a low-to-moderate-fat diet significantly reduces cardiovascular risk factors. Vegan diets were intermediate. Lowered-carbohydrate dieters were least inclined to continue dieting after conclusion of the study. Reductions in coronary blood flow reversed with appropriate dietary intervention. The major dietary effect on atherosclerotic coronary artery disease is inflammation and not weight loss.”

It has recently been retracted and it has come out that the lead author, Richard M. Fleming, has a long history of fraud going back to 2002 with two FBI convictions of fraud in 2009, following his self-confession. He has also since been debarred by the U.S. Food and Drug Administration. (But his closest brush with fame or infamy was his leaking the medical records of Dr. Robert Atkins, a leak that was behind a smear campaign.) As for his co-authors: “Three of the authors work at Fleming’s medical imaging company in California, one is a deceased psychologist from Iowa, another is a pediatric nutritionist from New York and one is a Kellogg’s employee from Illinois. How this group was able to run a 12-month diet trial in 120 subjects is something of a mystery” (George Henderson). Even before the retraction, many wondered how it ever passed peer-review considering the low quality of the study: “This study has so many methodological holes in it that it has no real value.” (Low Carb Studies BLOG).

But of course, none of that has been reported as widely as the paper originally was. So, most people who read about it still assume it is valid evidence. This is related to the replication crisis, as even researchers are often unaware of retractions, that is when journals will allow retractions to be published at all, something they are reluctant to do because it delegitimizes their authority. So, a lot of low quality or in some cases deceptive research goes unchallenged and unverified, neither confirmed nor disconfirmed. It’s rare when any study falls under the scrutiny of replication. If not for the lead author’s criminal background in the Fleming case, this probably would have been another paper that could have slipped past and been forgotten or else, without replication, repeatedly cited in future research. As such, bad research builds on bad research, creating the appearance of mounting evidence, but in reality it is a house of cards (consider the takedown of Ancel Keys and gang in the work by numerous authors: Gary Taubes’ Good Calories, Bad Calories; Nina Tiecholz’s The Big Fat Surprise; Sally Fallon Morrell’s Nourishing Diets; et cetera).

This is why the systemic problem and failure is referred to as a crisis. Fairly or unfairly, the legitimacy of entire fields of science are being questioned. Even scientists no longer are certain which research is valid or not. The few attempts at determining the seriousness of the situation by replicating studies has found a surprisingly low replication rate. And this problem is worse in the medical field than in many other fields, partly because of the kind of funding involved and more importantly because of how few doctors are educated in statistics or trained in research methodology. It is even worse with nutrition, as the average doctor gets about half the questions wrong when asked about this topic, and keep in mind that so much of the nutritional research is done by doctors. An example of problematic dietary study is that of Dr. Fleming himself. We’d be better off letting physicists and geologists do nutritional research.

There is more than a half century of research that conventional medical and dietary opinions are based upon. In some major cases, re-analysis of data has shown completely opposite conclusions. For example, the most famous study by Ancel Keys blamed saturated fat for heart disease, while recent reappraisal has shown the data actually shows a stronger link to sugar as the culprit. Meanwhile, no study has ever directly linked saturated fat to heart disease. The confusion has come because, in the Standard American Diet (SAD), saturated fat and sugar have been conflated in the population under study. Yet, even in cases like that of Keys when we now know what the data shows, Keys’ original misleading conclusions are still referenced as authoritative.

The only time this crisis comes to attention is when the researcher gets attention. If Keys wasn’t famous and Fleming wasn’t criminal, no one would have bothered with their research. Lots of research gets continually cited without much thought, as the authority of research accumulates over time by being cited which encourages further citation. It’s similar to how legal precedents can get set, even when the initial precedent was intentionally misinterpreted for that very purpose.

To dig through the original data, assuming it is available and one knows where to find it, is more work than most are willing to do. There is no glory or praise to be gained in doing it, nor will it promote one’s career or profit one’s bank account. If anything, there are plenty of disincentives in place, as academic careers in science are dependent on original research. Furthermore, private researchers working in corporations, for obvious reasons, tend to be even less open about their data and that makes scrutiny even more difficult. If a company found their own research didn’t replicate, they would be the last in line to announce it to the world and instead would likely bury it where it never would be found.

There is no system put into place to guard against the flaws of the system itself. And the news media is in an almost continual state of failure when it comes to scientific reporting. The crisis has been stewing for decades, occasionally being mentioned, but mostly suppressed, until now when it has gotten so bad as to be undeniable. The internet has created alternative flows of information and so much of the scrutiny, delayed for too long, is now coming from below. If this had happened at an earlier time, Fleming might have gotten away with it. But times have changed. And in crisis, there is opportunity or at very least there is hope for open debate. So bring on the debate, just as soon as we clear away some of the rubbish.

* * *

Retracted: Long‐term health effects of the three major diets under self‐management with advice, yields high adherence and equal weight loss, but very different long‐term cardiovascular health effects as measured by myocardial perfusion imaging and specific markers of inflammatory coronary artery disease

The above article, published online on 27 September 2018 in Wiley Online Library (wileyonlinelibrary.com), has been withdrawn by agreement between the journal Editor in Chief, A. John Camm and Wiley Periodicals, Inc. The article has been withdrawn due to concerns with data integrity and an undisclosed conflict of interest by the lead author.

A convicted felon writes a paper on hotly debated diets. What could go wrong?
by Ivan Oransky, Retraction Watch

Pro-tip for journals and publishers: When you decide to publish a paper about a subject — say, diets — that you know will draw a great deal of scrutiny from vocal proponents of alternatives, make sure it’s as close to airtight as possible.

And in the event that the paper turns out not to be so airtight, write a retraction notice that’s not vague and useless.

Oh, and make sure the lead author of said study isn’t a convicted felon who pleaded guilty to healthcare fraud.

“If only we were describing a hypothetical.

On second thought: A man of many talents — with a spotty scientific record
by Adam Marcus, Boston Globe

Richard M. Fleming may be a man of many talents, but his record as a scientist has been spotty. Fleming, who bills himself on Twitter as “PhD, MD, JD AND NOW Actor-Singer!!!”, was a co-author of short-lived paper in the journal Clinical Cardiology purporting to find health benefits from a diet with low or modest amounts of fat. The paper came out in late September — just a day before the Food and Drug Administration banned Fleming from participating in any drug studies. Why? Two prior convictions for fraud in 2009.

It didn’t take long for others to begin poking holes in the new article. One researcher found multiple errors in the data and noted that the study evidently had been completed in 2002. The journal ultimately retracted the article, citing “concerns with data integrity and an undisclosed conflict of interest by the lead author.” But Fleming, who objected to the retraction, persevered. On Nov. 5, he republished the study in another journal — proving that grit, determination, and a receptive publisher are more important than a spotless resume.

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