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

StellaLife’s Vega Oral Care Restoration Equipment

Stephen Barrett, a U.S. doctor and founding father of Quackwatch, makes a degree of calling out homeopathy and different well being merchandise and practices that lack proof. 

In that vein, earlier this yr he emailed the Journal of Oral and Maxillofacial Surgical procedure to critique a 2019 article by Walter Tatch titled “Opioid Prescribing Can Be Decreased in Oral and Maxillofacial Surgical procedure Follow,” which has been cited 5 occasions, in response to Clarivate’s Net of Science. 

The paper describes how Tatch, an oral surgeon in Illinois, adopted a brand new protocol in his workplace for managing sufferers’ ache after surgical procedure, which included “a homeopathic restoration package” marketed by his firm, and fewer sufferers stuffed prescriptions for opioids. 

Barrett and a colleague known as for a retraction, on the grounds that Tatch didn’t disclose the total extent of his battle of curiosity, that the research was poorly designed and had suspicious information, and that StellaLife was utilizing the article to advertise its product. The journal editor responded shortly: He wouldn’t retract the paper. However he additionally let the journals’ legal professionals know in regards to the promotion, and so they despatched StellaLife a cease-and-desist letter. 

Barrett wrote to a generic e mail handle for the journal along with his critiques (full letter right here) on Could tenth. He and William London, a professor at CalState, Los Angeles, wrote, partially: 

The obvious drawback is failure to reveal the writer’s battle of curiosity. The product is a described [sic] as a homeopathic restoration product made by StellaLife. The article doesn’t disclose that the writer holds the patent to the product and is a member of StellaLife’s board of administrators and that his spouse is an officer of the corporate. I assume that he receives appreciable compensation from StellaLife product gross sales, however even when he doesn’t, the patent possession could also be of appreciable future worth.

The research was poorly designed, It’s a retrospective chart assessment that purports to check the ache ranges of sufferers earlier than and after the introduction of an “Workplace Protocol” meant to scale back using postoperative narcotics. However ache ranges and precise narcotic use weren’t measured.

The editor-in-chief of the journal, Thomas B. Dodson of the College of Washington Faculty of Dentistry, responded on Could twelfth: 

Thanks for bringing your issues to my consideration.

The writer correctly disclosed his battle of curiosity on the time his paper was submitted.

The there [sic] is not any proof of educational misconduct that rises to the extent of retracting this publication. Your feedback would have been finest addressed within the type of a Letter to the Editor, however the time restrict to submit a letter has lengthy expired.

Barrett and London responded with an in depth rebuttal which we’ve made accessible in full right here. They argued that the disclosure that Tatch “owns shares of the StellaLife Firm” was inadequate, that the paper was of such poor high quality it mustn’t have been revealed, and that the journal mustn’t have a time restrict for coping with moral issues about articles. (Many journals have such limits, which some really feel prohibit postpublication peer assessment unnecessarily.) They concluded: 

Dr. Tatch’s article doesn’t signify sound proof. We imagine you’ve an moral obligation to curb its misuse.

Dodson responded in a letter on June twenty seventh, which is obtainable in full right here. He expanded on his counter-arguments and defined his occupied with what would warrant a retraction: 

We’ve asserted that there is no such thing as a proof of educational misconduct. We perceive that you just made no such declare, however it’s related as a result of it’s the foremost motive for which we might take the acute motion of retracting an article. Absent any proof of educational misconduct (eg, plagiarism, fraudulent information manipulation, intentional misrepresentation) we’re detest [sic] to re-adjudicate a publication from a number of years again. Retraction from a scientific journal is the capital punishment of educational company and we reserve such motion for probably the most agregious [sic] and confirmed of claims. This paper doesn’t rise to this stage of punishment.

Dodson additionally dismissed the thought that there have been any moral points with the paper: 

Your assertion that the article is of poor high quality doesn’t represent an moral violation. The paper was peer-reviewed and was subjected to three revisions earlier than being accepted for publication. The submission was made at a time when JOMS was looking for papers that supplied options to lowering opioid prescribing. As such, the subject was of eager curiosity to our readership.

The paper asserts that “opioid prescribing may be diminished.” It research an “workplace protocol” that features ibuprofen, acetaminophen, and a package as an alternative choice to opioid use. The paper is proscribed in that it’s retrospective in nature and never a randomized trial, nonetheless, it satisfactorily solutions the query that it seeks to reply—that opioid use may be diminished. The research was not designed to elucidate why and makes no assertion of causality. It makes no inference in regards to the function of the Stella Life package in relation to the therapeutic medication within the workplace protocol. In keeping with our editorial requirements, the model title Stella Life is used sparingly and in response to our model information. Once more, we discover no “moral violations.”

Nonetheless, Dodson stated that the journal had acted on Barrett’s info that StellaLife was utilizing the article it had revealed in its advertising and marketing: 

we notified our legal professionals at AAOMS [American Association of Oral and Maxillofacial Surgeons] that JOMS was being referenced in a approach that implied an endorsement of Stella Life. We’re grateful that you just known as this to our consideration. Stella Life was subsequently served with a cease-and-desist letter and instantly eliminated all point out of JOMS from its web site to our satisfaction. All that is still is a reference to the revealed article in JOMS amongst an inventory of 40 related references.

In response to our request for remark, Dodson wrote: 

Thanks to your follow-up communication. I want to reiterate {that a} retraction is pointless and that the suitable plan of action would have been a Letter to the Editor. I admire your curiosity, nonetheless, and shared your suggestions with AAOMS government management.

We additionally emailed Tatch for touch upon Barrett and London’s critiques. He wrote again with a point-by-point response, which is obtainable in full right here. He advised us: 

I feel most individuals would agree that lowering using opioids is a vital goal. StellaLife’s merchandise have helped many individuals keep away from or cut back using opioids in reference to oral and maxillofacial surgical procedure. We’ve intensive and rising scientific information and unbiased research confirming the efficacy of StellaLife’s merchandise (1-5). 

Sadly, StellaLife has not too long ago skilled unwarranted, even defamatory assaults on their merchandise and the intensive analysis behind them. I hope that you’re additionally investigating the supply of this criticism. The statements under are nearly totally inaccurate. I can solely surprise why somebody would go to such lengths to assault merchandise that assist individuals cut back opioid use. 

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

let me know whether or not the ADA plans to do something to guard its members and most of the people from being additional misled in regards to the product.

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