A journal has retracted the 2014 report of a clinical trial of a supplement touted as a way to reduce the risk of cardiovascular disease after beginning to suspect that the data were not reliable.
The study, “Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: A double-blinded, randomized, placebo controlled study,” was published in the Journal of Clinical Lipidology, an Elsevier title. It has been cited 42 times, according to Clarivate Analytics’ Web of Science.
The authors were Adam Bernstein and Michael Roizen, of the Wellness Institute at Cleveland Clinic, and Luis Martinez, who at the time was the president of the Xyrion Medical Institute, in Puerto Rico.
Roizen, an anesthesiologist and the founding chair of the Wellness Institute, is the co-creator of the RealAge test, which he developed along with Mehmet Oz.
Roizen and Oz have been hawking palmitoleic acid — an omega-7 fatty acid that is the subject of the now-retracted study — for some time. In this 2019 article, for example, the pair wrote:
You can be at the front of the next wave of smart nutritional choices by making sure you get a good supply of palmitoleate (that’s omega-7) from fatty fish (salmon, ocean trout, anchovies), some nuts (especially macadamia nuts) and avocados.
As a supplement, you want a purified omega-7 from fish (our favorite source) to dodge the cancer- and inflammation-promoting palm oil that plant sources may contain. So boost your omega-7 intake from food, and ask your doctor about your best dose of omega-7 supplements.
In 2012, Roizen joined the scientific advisory board of Tersus Pharmaceuticals, “the omega 7 company,” which made the product used in the now-retracted paper (Martinez also was on the company’s board, apparently).
The 2014 paper purported to provide the results of ”the first randomized controlled trial of purified palmitoleic acid supplementation in humans,” which Tersus funded, according to this press release.
Per the retraction notice:
This article has been retracted at the request of the Editor in Chief.
It has come to our attention that this article presents serious concerns about Food and Drug Administration guidance and about data or statistical interpretation. The statistical accuracy claimed in the published article is not consistent with known variability of lipoprotein cholesterol and triglyceride levels. For these reasons the article is hereby retracted.
Although the first part of the money paragraph is indecipherable, the second sentence translates roughly to: the data do not appear to be experimentally derived.
Timothy Gooding, the chairman and CEO of Tersus, told us that he was baffled by the retraction:
We can’t get any explanation for it. Mike Roizen doesn’t know why it was retracted, either.
However, Gooding added that the company has done “a number” of other studies on palmitoleic acid and that the retraction doesn’t make a significant dent in its prospects.
Roizen and Bernstein did not respond to a request for comment.
John Guyton, the editor-in-chief of the journal, didn’t offer much to clarify the cryptic retraction notice. However, when asked if the line about the results in the study being “not consistent with known variability” suggested that he was concerned the data were not experimentally derived, he responded:
That’s correct.
This is not the first time that a paper backing a product touted by Dr. Oz has been retracted. In 2014, a study about coffee bean extract that Oz used to promote the substance on his TV show was retracted over questions about the data and amid a $3.5 million settlement with the Federal Trade Commission with the company that made the extract.
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If “the company has done “a number” of other studies on palmitoleic acid and that the retraction doesn’t make a significant dent in its prospects”, then it might be a very good idea to look at those other publications as well to see how those data were actually generated as well…