n January, Minerva Surgical lost a patent infringement suit against Hologic, a rival manufacturer of a radiofrequency device for treating heavy bleeding in the uterus. But Minerva hasn’t raised the white flag.
Last month, the Redwood City, Calif., company issued a press release demanding the immediate retraction of a recent study showing that Hologic’s device for endometrial ablation is better than Minerva’s. According to the release, the article, which appears in a relatively obscure publication called the International Journal of Women’s Health (IJWH), makes “material misleading statements” about the nature of the study.
The allegations include misrepresentation of the number of patients who received treatment with Minerva’s device; inappropriate intervention in the study by Hologic “personnel”; and conflicting information about the incidence of bleeding after treatment.
According to Minerva, it obtained a copy of an earlier manuscript, which the authors had unsuccessfully shopped around to at least two other journals, with data showing that its product outperformed Hologic’s — data that do not appear in the published version.
David Clapper, Minerva’s CEO, told STAT that his company received the rejected manuscript from “a physician” he declined to identify. Clapper said that he became aware that the IJWH had received its version of the paper about four months ago, and that he contacted the publication then with his concerns about the article.
“We tried to stop it,” he said, but failed.
We can’t judge the essence of Minerva’s claims, although some — particularly that paid personnel for a device maker biased the selection process for patients in the trial — are quite troubling and would constitute grounds for retraction.
Demands for a retraction normally should be reserved for instances of misconduct and obvious errors that are fatal to the conclusions, according to the Committee on Publication Ethics. Does this case meet that standard?
The headline of the Minerva press release requests “immediate retraction.” Such urgency normally would make us more than a bit wary, given that science should be a careful, deliberative process. But in this case, we can understand the company’s need for speed. In an April 23 letter to the journal, Clapper expressed concern that Hologic would use reprints and other sales tools to market the flawed publication to “10,000 unsuspecting gynecologists” at the 2018 annual meeting of the American College of Obstetricians and Gynecologists, which was taking place April 27-30.
That wasn’t an empty fear. When an analyst raised the retraction request during Hologic’s May 2 conference call with investors, CEO Stephen MacMillan said the company felt “very good about the underlying way that, that study was done, so feel really, really good about that.” CFO Robert W. McMahon added that the new data would help his sales force “be much more competitive in the marketplace.”
Jane Mazur, a spokeswoman for Hologic, which paid for the study and compensated all four authors for their work (though one reports also being on Minerva’s speaker’s bureau), said the Marlborough, Mass.-based company “strongly disputes” Minerva’s assertion regarding patient selection. “We stand by the integrity of the investigators’ data and appreciate the rigorous standards” at Dove Press, Mazur said.
Regardless of Dove’s editorial standards, however, its journals are not what anyone would call widely read. Titles from the open-access publisher tend to rank poorly on impact factor, a measure — albeit highly imperfect — of how often their articles are cited. IWJF doesn’t have a conventional impact factor, which means that the company that calculates the metric hasn’t even seen fit to index the journal. Compare that to the reasonably healthy impact factor of the Journal of Minimally Invasive Gynecology — 3 — one of the places the authors tried first.
The editor of the IWJF did not respond to a request for comment from STAT. Neither did the senior author of the paper, Dr. Russell Stankiewicz, an OB-GYN in Lewisburg, Pa. A spokesperson for publisher Taylor & Francis, which acquired Dove in 2017, said the company is “currently working with the editor-in-chief to look into the concerns surrounding this paper.”
Ordinarily, we would say that science battles shouldn’t be waged by press release. And as we’ve noted before about such calls for retraction, “The sense one gets is that the people calling for these retractions — often followed by the word ‘immediately’ — are less interested in correcting the scientific record than they are in punishing those whose views they don’t share.”
However, in this case it’s hard to see what other options Minerva had, given that “going through channels” failed. What appears to be a deeply flawed paper sailed through that “rigorous” process.
And that gets to a larger point: Treating peer review like the Good Housekeeping Seal of Approval of “truth” — or even “reliability” — is fraught. As this episode shows, companies will flog even the most dubious published data to boost their market share. The lesson, then, for consumers of scientific information, from scientists to investors, is reader beware.