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 September 27 of this year, Richard M. Fleming — that’s “PhD, MD, JD AND NOW Actor-Singer!!!” according to his Twitter profile — and colleagues published a paper in Clinical Cardiology. The paper, a comparison of “the three major diets,” concluded:
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.
The next day, the very same Richard M. Fleming was debarred by the U.S. Food and Drug Administration
for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Fleming was convicted of two felonies under Federal law that involved fraud. Additionally, Fleming has demonstrated a pattern of conduct sufficient to find that there is reason to believe that he may violate requirements under the FD&C Act relating to drug products.
Indeed, as the Lincoln Journal-Star reported in 2010:
Fleming admitted that in 2002 he billed Medicare, Medicaid and Blue Cross Blue Shield of Nebraska for falsely represented medical tests.
In 2004, Fleming admitted, he submitted false data after being paid to perform a clinical study on the health benefits of a soy chip food product.
Within days, you might say that the knives came out. On September 30, George Henderson posted a blog item alleging numerous problems with the study. One of the things that Henderson points out is that this study — at least according to the trial’s registration — was apparently completed in 2002.
On October 18, Ben Hogan, senior publisher at Wiley, the publisher of Clinical Cardiology, wrote to Fleming:
We have been alerted by several readers to concerns about the article, particularly the dataset and the funder. Further, given the recent FDA ruling, in order to proceed with publication of the manuscript, we will need to see the original ethics board review, statements of consent from participants, and original data for further review. We take these matters extremely seriously and want to ensure that everything is cleared before publication. The article is currently on hold.
A lot to unpack there. First, the funder, as noted in the paper, was the Camelot Foundation, a nonprofit that Fleming appears to have founded. Second, while the FDA ruling was recent, Fleming’s conviction wasn’t: It was in 2009. Third, we’ve seen a number of cases in which failure to obtain proper IRB approval — which is of course a serious matter — is used as a rationale for retracting a paper with much more serious flaws, but obviating the need for a larger investigation, sort of like getting Al Capone on tax evasion.
Finally, the paper was already published, with a DOI and all the other trimmings, so saying that it was somehow in a “before publication” state isn’t accurate — even if some publishers would like “do-overs” for papers that are published online but aren’t yet assigned to an issue.
Hogan gave Fleming 48 hours “to confirm that the data is available.” Fleming responded in that timeframe, sending Wiley what they requested. But on October 23, Hogan wrote back to him, saying that the article would be retracted in a few days:
The reasoning is as described previously.
Sometime between then and today — we think it was in late October, although the retraction notice doesn’t say — the paper was retracted:
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.
The lack of date isn’t the only thing that’s unclear in the notice. What “concerns with data integrity” led to the retraction? Were they the ones Henderson raised? And what was the undisclosed conflict of interest by the lead author, aka Fleming?
Hogan did not immediately respond to a request for comment.
‘I don’t agree’
We asked Fleming — one of whose co-authors, Gordon Harrington, died in 2015 — whether he agreed with the retraction, and whether he could say why the paper was withdrawn:
No, I don’t agree with the retraction of the paper. The major purpose of the study was to investigate the impact of dietary counseling and the ability of people to[,] through self-efficacy counseling[,] regulate their own dietary habits. This was demonstrated independent of which dietary regimen people were on. When I started sharing the online version, ahead of print issue, I started receiving criticism from the Low Carbohydrate group. While the initial conversations were negative, with discussion that seemed to dissipate however the complaints had already been sent in.
Per the request of the Journal I submitted an IRB form and the original raw data. The journal elected to retract the paper due to questions of data validity and a conflict of interest. I am not certain what the conflict was and I have seen no documentation that the data is invalid. As a journal reviewer for more than a dozen journals, it is in the end, the journal[‘]s decision and I believe their loss.
Fleming republished the paper in the journal Biomedical Journal of Scientific & Technical Research on November 5, after submitting it there October 27. Questions have been raised about the publisher of that journal, which shares an address with at least two other publishers. Asked whether he felt the review was sufficient, Fleming tells Retraction Watch:
The review was not of the originally submitted paper but the multiple revised paper approved for publication by Clinical Cardiology. It is much easier to review that which has already been reviewed and re-written than an original submission. I currently review for or have reviewed for 26 Journals, and was a NIH Grant Reviewer from 2006-2016. I am currently reviewing a paper for one of those journals, which I will have done by tomorrow. Turn around time is not dependent upon the complexity of what is written but by the motivation of those reviewing.
Your REAL question is do I think they did a sloppy job. The answer is NO.
Fleming — who was involved in another keruffle in 2004 involving diet doctor Robert Atkins’ death certificate — also told us that he was never notified of his debarment, but that he came across it on the Internet. He said that he has
filed a reply to the debarment and demanded a retracting and hearing.
He also said that
there was never any Data Fraud and there was never the admission by myself of any wrong doing.
According to an FBI news release from 2009, Fleming was
sentenced today in Lincoln, Nebraska, by the Honorable Richard G. Kopf to five years probation with six months home detention, including electronic monitoring, and ordered to pay restitution in the amount of $107,244.24 for the felony offenses of health care fraud and mail fraud.
Hat tip: Aseem Malhotra
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