Lack of conflict of interest disclosure undoes scoliosis study

scoliosisThe journal Scoliosis has retracted a 2012 paper by a pair of German spine doctors over what the editors have called a less-than-fully declared conflict of interest involving one of the authors.

That should be relatively straigtforward – but it’s not quite. Turns out the article does include a disclosure, although perhaps the information it contains was incomplete.

The article, “Soft braces in the treatment of Adolescent Idiopathic Scoliosis (AIS) – Review of the literature and description of a new approach,” was written by Hans-Rudolf Weiss and Mario Werkmenn. Weiss, it seems, has something of a pedigree in the field. According to this website, he practices the “Schroth method” of recurvature, a technique pioneered by his grandmother, Katharina Schroth. From the site:

[Schroth] dedicated countless hours attempting different corrections of her curve and discovered certain positions, movements and breathing techniques which made her own torso deformity less obvious.

Trained as a teacher, Ms. Schroth started sharing her techniques with patients in the 1920’s and eventually established her own clinic in Germany. Her daughter, Christa Lehnert-Schroth P.T. ( and helped her further develop the theory underlying the Schroth Method. Katharina’s grandson, Dr. Hans-Rudolph Weiss, MD has continued the tradition by developing his own unique program called Scolio-Logic in Germany. The Schroth family has authored books, produced numerous articles, and educated others on these non-surgical techniques. Although no longer owned by the Schroth family today, over one thousand patients are treated annually at Asklepios Katharina-Schroth Klinic in Germany and there is frequently a several month long waiting list.

The Schroth family, through Weiss, also has invented a brace for patients with scoliosis. And therein lies the problem.

According to the journal, Weiss failed to adequately disclose his invention in the article — which, not surprisingly, focuses a fair amount of ink on the device, called the Spinealite (the “new approach” in the title). Although, to be fair, it’s not exactly a glowing report. Consider:

At this moment we apply the new soft brace system (Spinealite™) together with high corrective hard braces, 12 hrs. each, however with increasing numbers of patients and increased experience we do hope to offer this new soft brace as the sole form of treatment for adolescents during growth in the near future.

Although there is a small body of papers on soft brace treatment as found in literature [12-17,27-44] we would not expose our patients to the risk of sole softbrace treatment as some of the papers reveal contradictory outcomes [15-17,30,32,34] and restrictions to use certain types of braces with respect to curve patterns [30]. At this stage there is no evidence that the Spinealite™ can improve the outcome of soft bracing, however the principle of applying corrective movements as described by Fischer [1] and later by Coillard [12-14] has been found to be beneficial to some extent. The trunk shift in combination with the other 3D corrective movements is a powerful corrective force as can be seen on Figure 4. The addition of a sagittal corrective movement theoretically should enable to improve the outcome of soft bracing additionally [18-20], but this finally has to be proven in future studies. This new soft brace has been shown to be able to correct a scoliosis to an extent comparable to high corrective hard braces. Therefore we expect beneficial outcomes when the brace can be worn as prescribed [9,26].

Pretty tepid endorsement, as these things go. At the bottom of the paper, under the subhead “Competing interests,” is this line:

HRW is advisor of Koob-Scolitech, Abtweiler, Germany and has applied for patents.

But that’s not really the whole story, because, at least according to this website, Weiss’ name appears as the inventor/developer at Koob-Scolitech, not merely as an adviser to the company. (We noticed that some of the images on the company’s official website appear in the Scoliosis article but do not state that they are marketing material, a definite Nicht, Nicht!.)

So maybe that explains why the editors decided to retract the article, rather than issue a correction (we’ve seen both in similar cases):

The Editor-in-Chief and the Medical Editors at BioMed Central have retracted this article [1] because the first author did not fully declare his association with Koob Scolitech, which holds the rights in and to the Spinealite™ brace and has filed for a patent for that brace. Furthermore, the direct association between Koob Scolitech and the Spinealite™ brace was not made clear in the article. This undeclared competing interest compromised the peer review process.

The paper has yet to be cited, according to Thomson Scientific’s Web of Knowledge.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.