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To the Editor: We wish to notify you and the JAMA readers of undisclosed potential conflicts of interest with respect to an article that we published in JAMA in 2006¹ and a letter to the editor we published in JAMA in 2007.²

From 2000 to 2007, the Cornell Research Foundation Inc (CRF), a subsidiary of Cornell University, filed patent applications that cover a variety of computer-aided diagnostic methods, including measurement of nodules. These applications are for general diagnostic use. We are listed as co-inventors, among others. Starting in 2001, the CRF licensed certain of these technologies to General Electric and has received royalties. The license agreement was between General Electric and Cornell, the institution listed on the title page. A portion of the royalties are distributed to both of us and to the other co-inventors pursuant to Cornell policy, which in turn is consistent with the Bayh-Dole Act. One patent was issued on September 25, 2007, relating to measuring change in an object in any organ of a mammal using any type of imaging technique.

The JAMA article¹ examined lung-cancer susceptibility and lung cancer survival in women as compared with men. This article reviewed data from the International Early Lung Cancer Action Program (I-ELCAP) screening cohort and showed that women are more susceptible to lung cancer than men of equal age and smoking history, but that their survival was better. The I-ELCAP cohort was a suitable database to examine these sex differences, as would have been any other cohort prospectively enrolled and followed for diagnosis of lung cancer. Since the first publication in 1999 of our results on screening for lung cancer,³ the regimen used to perform these screenings has been in the public domain and on our Web site. No pending patent applications or products developed as a result of the licensing agreement with General Electric were required in any of the screenings. This article was not intended to and did not examine the merits of computed tomography screening as a predictive or preventive tool in the fight against lung cancer but did speculate about the need to screen women at lower levels of smoking history than men.

The letter to the editor² described our concerns about a study by Bach et al⁴ that was cautious about the value of computed tomography screening for lung cancer. It was submitted on April 13, 2007, and accepted on June 27, 2007.

We believe that none of the patent applications or the license agreement played any role in the design of the study, interpretation of the data, or drafting of the publications in JAMA and therefore did not disclose them. However, we recognize that JAMA policy requires disclosure of any potential conflicts of interest, and in retrospect we regret that we did not disclose these financial relationships (detailed next). We apologize for any misperceptions that may have resulted.

See Reply and Correction 1 and 2.

Published Online: March 24, 2008 (doi:10.1001/jama.299.15.jle80054).

Financial Disclosures: Drs Henschke and Yankelevitz reported being listed as co-inventors for the following patent and patent applications: US Patent No. 7,274,810, "System and Method for Three-Dimensional Image Rendering and Analysis" (patent issued to CRF September 25, 2007); US Patent Application No. 10/245,782, "System, Method and Apparatus for Small Pulmonary Nodule Computer Aided Diagnosis from Computed Tomography Scans" (CRF pending patent application); US Patent Application No. 11/827,985, "System and Method for Three-Dimensional Image Rendering and Analysis" (CRF pending divisional application); US Patent Application No. 11/827,994, "System and Method for Three-Dimensional Image Rendering and Analysis" (CRF pending divisional application); US Patent Application No.10/688,267, "System, Method and Apparatus for Small Pulmonary Nodule Computer Aided Diagnosis from Computed Tomography Scans" (CRF pending patent application); US Patent Application No. 10/901,316, "System and Method for Providing Remote Analysis of Medical Data" (CRF pending patent application); US Patent Application No.10/932,443, "System and Method for Analyzing Medical Data to Determine Diagnosis and Treatment" (CRF pending patent application); US Patent Application No. 10/901,362, "System and Method for Conducting a Clinical Trial Study" (CRF pending patent application); US Patent Application No. 11/688,980, "Medical Imaging Visibility Index System and Method for Cancer Lesions" (CRF patent cooperation treaty application also pending); US Patent Application No. 11/377,031, "Method for Expanding the Domain of Imaging Software in a Diagnostic Workup" (CRF pending patent application) (foreign patent applications also pending); US Patent Application No. 11/858,855, "System and Method for Position Matching of a Patient for Medical Imaging" (CRF pending patent application); and "Medical Imaging System for Accurate Measurement Evaluation of Changes in a Target Lesion" (foreign patent applications pending) (Henschke/Yankelevitz pending patent application). Dr Henschke reported receiving compensation for serving as a member of a National Cancer Institute study section. Dr Yankelevitz reported being an inventor on a pending patent related to biopsy needles assigned to PneumRX, being a paid medical advisor to PneumRX, and holding stock in PneumRX.

Claudia I. Henschke, PhD, MD
chensch{at}med.cornell.edu

David F. Yankelevitz, MD
Department of Radiology
Weill Medical College of Cornell University
New York, New York

1. International Early Lung Cancer Action Program Investigators, Henschke CI, Yip R, Miettinen OS. Women's susceptibility to tobacco carcinogens and survival after diagnosis of lung cancer. JAMA. 2006;296(2):180-184. FREE FULL TEXT 2. Henschke CI, Yankelevitz D, Smith JP, Miettinen OS. Computed tomography screening for lung cancer. JAMA. 2007;298(5):514-515. FREE FULL TEXT 3. Henschke CI, McCauley D, Yankelevitz DF; et al. Early Lung Cancer Action Project: overall design and findings from baseline screening. Lancet. 1999;354(9173):99-105. FULL TEXT | WEB OF SCIENCE | PUBMED 4. Bach PB, Jett JR, Pastorino U, Tockman MS, Swensen SJ, Begg CB. Computed tomography screening and lung cancer outcomes. JAMA. 2007;297(9):953-961. FREE FULL TEXT

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2008;299(15):1770. Published online March 24, 2008 (doi:10.1001/jama.299.15.jle80054).

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