Wednesday, July 07, 2004
One tissue bank has developed and implemented a low-temperature chemical-sterilization approach (BioCleanse) that kills spores but preserves the biomechanical integrity and function of some allografts. The efficacy of this sterilization method is supported by the absence of reports of bacterial or viral allograft-associated infections in tissue processed by this method (CDC: unpublished data). In contrast, tissues processed with all other disinfection and sterilization methods, including gamma irradiation, have been associated with reports of allograft-associated infections (CDC: unpublished data). Currently, BioCleanse and other sterilization methods cannot be used to process fresh femoral condyles, since it is thought that chondrocytes must be viable to maintain articular cartilage function. (emphasis mine)
Nice to see all those assertions from unpublished data thrown about after such a recent uproar over the importance of research transparency.
The authors say someone at the Journal told them they didn't have to disclose their ties to the company, and anyways, the paper was submitted before Dr. Archibald joined the maker of BioCleanse:
After clearance by the director of the Division of Healthcare Quality Promotion, the manuscript was submitted to the Journal for publication in December 2002...On January 20, 2003, Dr. Archibald became an employee of Regeneration Technologies, the manufacturer of BioCleanse. Stock options were granted to Dr. Archibald subsequent to his employment at Regeneration Technologies, subject to a vesting program over a period of five years. The article was accepted for publication, pending revision, by the
Journal in March 2004. Dr. Archibald signed a financial-disclosure form on August 1, 2003, attesting in good faith that the investigation had been conducted and completed
while he was employed by the CDC. Dr. Archibald did not indicate on that financial-disclosure form that he was now employed by Regeneration Technologies. In March 2004, Dr. Archibald orally discussed his new affiliation with staff at the Journal. It was his understanding that no further revision of his financial disclosure was required.
What are the chances that Dr. Archibald had not a clue in December that he might be joining Regeneration Technologies the next month? And although a two year lag time between submission and publication is fairly standard, he surely must have known in August 2003 that disclosing his ties with the company was the right thing to do.
The editors say they were duped:
When we publish a research report, our policy is to disclose to readers any relevant financial ties of the authors. To accomplish that, we rely on disclosure forms that all authors complete and sign. It is essential that we receive this information in writing; we cannot rely on telephone communication. In this case, Dr. Archibald’s disclosure form, completed on August 1, 2003, stated that he had no relevant financial associations. Specifically, his form did not indicate that after the research was completed, he became an employee of Regeneration Technologies, an association that is relevant because Regeneration Technologies makes BioCleanse, a product that is mentioned in the article. It is our policy that disclosure forms must reflect the most current information. If this author’s new affiliation had been indicated on the disclosure form, it would have been printed in the article according to our policy. The above letter with the financial disclosure has been linked permanently to the article as a correction, both on the Journal Web site and in the Medline database.
Except that the financial disclosure is very hard to find on the web version of the article (it's just a "correction" link in the upper right hand corner underneath a lot of other links), and it isn't attached to the medline citation at all.
The wonderful thing about the internet is that corrections and addenda can be added to articles and posts easily, unlike the printed page. And that's what the NEJM should do with this. Add an addendum to the online version that is easily seen and doesn't require opening another link. It's the right thing to do.
UPDATE: You may wonder why on earth the editor of a premier scientific journal would allow such prominent product placement in a scientific paper. Normally, drugs and such are identified only by their generic or chemical names in studies. Don't medical editors edit? Well, in this case, it could be because the editor doesn't think it's a problem.
posted by Sydney on 7/07/2004 11:22:00 PM 0 comments