Journal sends cease-and-desist letter to a company marketing a homeopathic alternative to opioids

Stephen Barrett, a U.S. physician and founder of Quackwatch, makes a point of calling out 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 Prescribing Can Be Reduced in Oral and Maxillofacial Surgery Practice,” which has been cited five times, according to Clarivate’s Web of Science. 

The paper describes how Tatch, an oral surgeon in 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 fewer patients filled prescriptions for opioids. 

Barrett and a colleague called for a retraction, on the grounds that Tatch didn’t disclose the full extent of his conflict of interest, that the study was poorly designed and had suspicious data, and that StellaLife was using the article to promote its product. The journal editor responded quickly: He would not retract the paper. But he also let the journals’ lawyers know about the promotion, and they sent StellaLife a cease-and-desist letter. 

Barrett wrote to a generic email address for the journal with his critiques (full letter here) on May 10th. He and William London, a professor at CalState, Los Angeles, wrote, in part: 

The most obvious problem is failure to disclose the author’s conflict of interest. The product is a described [sic] as a homeopathic recovery product made by StellaLife. The article does not disclose that the author holds the patent to the product and is a member of StellaLife’s board of directors and that his wife is an officer of the company. I assume that he receives considerable compensation from StellaLife product sales, but even if he doesn’t, the patent ownership may be of considerable future value.

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

The editor-in-chief of the journal, Thomas B. Dodson of the University of Washington School of Dentistry, responded on May 12th: 

Thank you for bringing your concerns to my attention.

The author properly disclosed his conflict of interest at the time his paper was submitted.

The there [sic] is no evidence of academic misconduct that rises to the level of retracting this publication. Your comments would have been best addressed in the form of a Letter to the Editor, but the time limit to submit a letter has long expired.

Barrett and London responded with a detailed rebuttal which we’ve made available in full here. They argued that the disclosure that Tatch “owns shares of the StellaLife Company” was insufficient, that the paper was of such poor quality it should not have been published, and that the journal should not have a time limit for dealing with ethical concerns about articles. (Many journals have such limits, which some feel restrict postpublication peer review unnecessarily.) They concluded: 

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

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

We have asserted that there is no evidence of academic misconduct. We understand that you made no such claim, but it is relevant because it is the main reason for which we would take the extreme action of retracting an article. Absent any evidence of academic misconduct (eg, plagiarism, fraudulent data manipulation, intentional misrepresentation) we are loathe [sic] to re-adjudicate a publication from several years back. Retraction from a scientific journal is the capital punishment of academic agency and we reserve such action for the most agregious [sic] and proven of claims. This paper does not rise to this level of punishment.

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

Your assertion that the article is of poor quality does not constitute an ethical violation. The paper was peer-reviewed and was subjected to 3 revisions before being accepted for publication. The submission was made at a time when JOMS was seeking papers that offered alternatives to reducing opioid prescribing. As such, the topic was of keen interest to our readership.

The paper asserts that “opioid prescribing can be reduced.” It studies an “office protocol” that includes ibuprofen, acetaminophen, and a kit as an alternative to opioid use. The paper is limited in that it is retrospective in nature and not a randomized trial, however, it satisfactorily answers the question that it seeks to answer—that opioid use can be reduced. The study was not designed to explain why and makes no assertion of causality. It makes no inference about the role of the Stella Life kit in relation to the therapeutic drugs in the office protocol. In line with our editorial standards, the brand name Stella Life is used sparingly and according to our style guide. Again, we find no “ethical violations.”

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

we notified our lawyers at AAOMS [American Association of Oral and Maxillofacial Surgeons] that JOMS was being referenced in a way that implied an endorsement of Stella Life. We are grateful that you called this to our attention. Stella Life was subsequently served with a cease-and-desist letter and immediately removed all mention of JOMS from its website to our satisfaction. All that remains is a reference to the published article 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 would like to reiterate that a retraction is unnecessary and that the appropriate course of action would have been a Letter to the Editor. I appreciate your interest, however, and shared your feedback with AAOMS executive leadership.

We also emailed Tatch for comment on Barrett and London’s critiques. He wrote back with a point-by-point response, which is available in full here. He told us: 

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

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

Barrett had also written to the president of the American Dental Association, pointing to an article posted on Quackwatch about StellaLife. He concluded: 

let me know whether 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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