Journal sends cease-and-desist letter to company marketing homeopathic alternative to opioids – Retraction Watch

StellaLife Vega Oral Care Recovery Kit

Stephen Barrett, American physician and founder of Charlatanwants to challenge homeopathy and other health products and practices that lack evidence.

In that vein, earlier this year he emailed the Journal of Oral and Maxillofacial Surgery to critique a 2019 article by Walter Tatch titled “Opioid prescription may be reduced in the practice of oral and maxillofacial surgerywhich was cited five times, according to Clarivate’s Web of Science.

The article describes how Tatch, an oral surgeon from Illinois, adopted a new protocol in his office for managing patients’ pain after surgery, which included “a homeopathic recovery kit” marketed by his company, and less patients filled opioid prescriptions.

Barrett and a colleague demanded a retraction, on the grounds that Tatch had not disclosed the full extent of his conflict of interest, that the study was poorly designed and contained questionable data, and that StellaLife was using the article to promote their product. The newspaper’s editor responded quickly: he would not withdraw the article. But he also notified the journals’ attorneys of the promotion, and they sent StellaLife a cease and desist letter.

Barrett wrote to a generic email address for the newspaper with her reviews (full letter here) on May 10. He and William London, a professor at CalState, Los Angeles, wrote:

The most obvious problem is the failure to disclose the author’s conflict of interest. The product is described [sic] as a homeopathic recovery product manufactured by StellaLife. The article does not reveal that the author owns the patent for the product and is a board member of StellaLife and that his wife is an executive of the company. I assume he receives considerable compensation from the sales of StellaLife products, but even if he does not, ownership of the patent may have considerable future value.

The study was poorly designed. This is a retrospective chart review that purports to compare patients’ pain levels before and after the introduction of an “office protocol” intended to reduce the use of postoperative narcotics. But pain levels and actual narcotics use were not measured.

The journal’s editor, Thomas B. Dodson of the University of Washington School of Dentistry, responded on May 12:

Thank you for bringing your concerns to my attention.

The author duly disclosed his conflict of interest at the time his article was submitted.

The, the [sic] there is no evidence of academic misconduct that rises to the level of retraction from this publication. Your comments would have been better addressed in the form of a letter to the editor, but the deadline for submitting a letter has long expired.

Barrett and London responded with a detailed rebuttal which we have made available in full here. They argued that the disclosure that Tatch “owns stock in StellaLife” was insufficient, that the article was of such poor quality that it should not have been published, and that the review should not have any time limit to address ethical concerns about articles. . (Many journals have such limitswhich some argue unnecessarily restricts post-publication peer review.) They concluded:

Dr. Tatch’s article does not represent solid evidence. We believe you have an ethical obligation to limit its misuse.

Dodson responded in a letter on June 27, which is available in full here. He elaborated on his counter-arguments and explained his thinking on what would justify a retraction:

We claimed there was no evidence of academic misconduct. We understand you didn’t make such a claim, but it’s relevant as it’s the primary reason we would take the extreme action of removing an item. In the absence of any evidence of academic misconduct (e.g. plagiarism, fraudulent manipulation of data, intentional misrepresentation), we dislike [sic] to re-evaluate a publication that is several years old. The retraction of a scientific journal is the capital punishment of the academic agency and we reserve such action for the most aggressive. [sic] and proven claims. This diary does not rise to that level of punishment.

Dodson also dismissed the idea that there were ethical issues with the paper:

Your assertion that the article is of poor quality does not constitute an ethical violation. The article was peer reviewed and went through 3 reviews before being accepted for publication. The submission came at a time when JOMS was looking for articles that offered alternatives to reducing opioid prescribing. As such, the topic has been of great interest to our readers.

The document claims that “opioid prescribing can be reduced.” He is studying an “office protocol” that includes ibuprofen, acetaminophen and a kit as an alternative to using opioids. The article is limited in that it is retrospective in nature and not a randomized trial, however, it satisfactorily answers the question it seeks to answer, which is that opioid use can be reduced. The study was not designed to explain why and makes no claims of causation. It makes no inferences about the role of the Stella Life kit versus therapeutic drugs in the practice protocol. In accordance with our editorial standards, the Stella Life brand name is used sparingly and according to our graphic charter. Again, we find no “ethical violation”.

However, Dodson said the newspaper acted on Barrett’s information that StellaLife was using the article he published in its marketing:

we have notified our lawyers at AAOMS [American Association of Oral and Maxillofacial Surgeons] that JOMS was referenced in a way that implied an endorsement by Stella Life. We are grateful to you for drawing our attention to this point. Stella Life subsequently received a cease and desist letter and immediately removed all mention of JOMS from its website to our satisfaction. There remains only one reference to the article published in JOMS among a list of 40 similar references.

In response to our request for comment, Dodson wrote:

Thank you for your follow-up communication. I want to reiterate that a retraction is not necessary and the proper course of action would have been a letter to the editor. I appreciate your interest, however, and have shared your comments with the AAOMS executive leadership.

We also emailed Tatch to comment on Barrett’s and London’s reviews. He responded with a point-by-point answer, which is available in full here. He told us:

I think most people would agree that reducing opioid use is an important goal. StellaLife’s products have helped many people avoid or reduce the use of opioids in oral and maxillofacial surgery. We have extensive and growing clinical data and independent studies confirming the effectiveness of StellaLife products (1-5).

Unfortunately, StellaLife has recently suffered unwarranted, even defamatory, attacks on its products and the extensive research behind them. I hope you are also investigating the source of this review. The statements below are almost entirely inaccurate. I can only wonder why anyone would go to such lengths to attack products that help people reduce their opioid intake.

Barrett had also written to the president of the American Dental Association, pointing out a article posted on Quackwatch about Stella Life. He concluded :

let me know if the ADA plans to do anything to protect its members and the general public from being further misled about the product.

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