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Previous Volume 351:397-398 July 22, 2004 Number 4 Next

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To the Editor: Our article on clostridium infections associated with musculoskeletal-tissue allografts (June 17 issue)¹ describes an epidemiologic investigation that was initiated by the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention (CDC), in November 2001 and concluded in April 2002. Dr. Marion A. Kainer carried out the investigation and was supervised by Dr. Lennox K. Archibald. A manuscript describing the investigation was completed in August 2002. After clearance by the director of the Division of Healthcare Quality Promotion, the manuscript was submitted to the Journal for publication in December 2002. There were no changes to the discussion relating to the BioCleanse process, which was mentioned in the article, between the time the manuscript was submitted and publication.

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. Although Dr. Kainer noted in revised manuscripts that Dr. Archibald was no longer affiliated with the CDC and was now working for Regeneration Technologies, this point was not separately addressed in an accompanying letter to the editor, and Dr. Archibald's new affiliation failed to appear in the publication.

We regret any perception of impropriety that might have resulted from Dr. Archibald's subsequent employment with Regeneration Technologies after his tenure with the CDC.

At no stage has Dr. Kainer been a paid expert witness on behalf of any tissue bank. However, after having left the CDC she was retained late in 2002 as an expert witness on behalf of patients affected by Tissue Bank A and shareholders who are filing a class-action lawsuit. In the article, per CDC policy, the use of trade names and commercial sources is for identification only and does not imply endorsement by the Department of Health and Human Services.

Marion A. Kainer, M.B., B.S., M.P.H.
Tennessee Department of Health
Nashville, TN 37247

Lennox K. Archibald, M.B., B.S.
Regeneration Technologies
Alachua, FL 32616

Editor's note: 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.

References

1. Kainer MA, Linden JV, Whaley DN, et al. Clostridium infections associated with musculoskeletal-tissue allografts. N Engl J Med 2004;350:2564-2571. [Free Full Text]

PDF PDA Full Text Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article by Kainer, M. A. PubMed Citation

This article has been cited by other articles:

• De Andrade, J. R., Ray, G. S., Pruss, A., Gobel, U. B., Pauli, G., Polder, J. A., Wood, J. J., Braun, M. M., Kainer, M. A., Jarvis, W. R. (2004). Infections Associated with Musculoskeletal-Tissue Allografts. NEJM 351: 1358-1360 [Full Text]