Authors retract two papers on Remicade following legal battles

A group of Belgian researchers has retracted two decade-old papers in Arthritis & Rheumatism following an investigation and court case.

The papers involved the use of the drug infliximab — sold by Johnson & Johnson as Remicade  — to treat Sjögren’s syndrome, an auto-immune condition marked by the destruction of exocrine glands that secrete saliva and tears.

Infliximab is not approved for Sjögren’s. Although the two now-retracted studies suggested that it might be helpful, subsequent data did not support those findings.

Neither, apparently, did the studies themselves. Here’s the retraction notice (it’s a PDF):

Notice of Retraction of Two Articles (“Infliximab in patients with primary Sjögren’s syndrome: a pilot study” and “Infliximab in patients with primary Sjögren’s syndrome: one-year followup”)

Two articles from Arthritis & Rheumatism, “Infliximab in patients with primary Sjögren’s syndrome: a pilot study” by Steinfeld SD, Demols P, Salmon I, Kiss R, and Appelboom T (published online on October 12, 2001) and “Infliximab in patients with primary Sjögren’s syndrome: one-year followup” by Steinfeld SD, Demols P, and Appelboom T (published online on December 12, 2002) in Wiley Online Library (wileyonlinelibrary.com) have been retracted by agreement between the authors, the American College of Rheumatology, the journal Editor-in-Chief, and Wiley Periodicals, Inc.

In these articles we reported on an open-label study that appeared to demonstrate that infliximab treatment was effective in patients with primary Sjögren’s syndrome. We regretfully report that some methodologic errors in the treatment of the data were discovered. In fact, the results of the study did not demonstrate an effect of infliximab in Sjögren’s syndrome. Consequently, the results reported in these articles should be disregarded.

The 2001 paper has been cited 104 times, according to Thomson Scientific’s Web of Knowledge, while the 2002 paper has been cited 47.

The first author of the articles was Serge D. Steinfeld, of Erasme University Hospital. He also was a paid consultant to Schering-Plough, since swallowed up by Merck, which markets Remicade in some parts of the world.

We have tried to reach Steinfeld, with no success so far.

Meanwhile, we were curious why it has taken more than 10 years for the A&R to retract these two studies. We asked Joan Bathon, the journal’s editor. Here’s her reply:

[I]t was brought to our journal’s attention 4-5 years ago but we were waiting for investigative and then legal proceedings in the investigator’s home country to be concluded.

Apparently, a lawsuit filed in Belgium claimed there were fraudulent data in the mix, but the hospital charts required to figure out what had gone on had been destroyed by a third uninterested party as part of normal housecleaning, according to previous A&R editor Michael Lockshin.

We were thus faced with competing arguments that we could not independently resolve. We therefore deferred the editorial decision until the court case concluded. There was no decision by the time my editorship ended.

The court case was dropped by mutual agreement, Bathon said, and Erasme ruled on the fraud, although we don’t know the outcome of that investigation. The authors retracted the studies themselves.

We emailed the ethics unit at Erasme for comment and will update this post if we learn more.