Last April, The Cancer Letter and The New York Times jointly published an investigation into the International Early Lung Cancer Action Program (I-ELCAP) run by Claudia Henschke and David Yankelevitz. Other researchers had already criticized the design and conclusions of that trial, but as the investigation noted, an October 2008 review of the study found that the researchers couldn’t find 90 percent of the subjects’ consent forms, an ethical no-no that jeopardizes as many as 135 papers.
Two papers published in Cancer, in 2000 and 2001, are among those studies, according to the notice (links added), which credits the Times and The Cancer Letter and notes that the journal has referred the case to Federal investigators:
Cancer is publishing an Editorial Expression of Concern regarding the following articles:
‘‘Early Lung Cancer Action Project: Overall Design and Findings From Baseline Screening’’ by Claudia I. Henschke (Cancer. 2000;89(suppl 11):2474-2482).
‘‘Early Lung Cancer Action Project: Initial Findings on Repeat Screenings’’ by Claudia I. Henschke, David P. Naidich, David F. Yankelevitz, Georgeann McGuinness, Dorothy I. McCauley, James P. Smith, Daniel Libby, Mark Pasmantier, Madeline Vazquez, June Koizumi, Douglas Flieder, Nasser Altorki, and Olli S. Miettinen (Cancer. 2001;92:153-159).
This Expression of Concern is based on an April 29, 2011, article in The New York Times as well as the April 29, 2011, issue of The Cancer Letter, both of which disclosed details of a report of an Independent Scientific Review Committee (Review Committee) convened by Weill Cornell Medical College to investigate the scientific research conducted as part of the International Early Lung Cancer Action Program (I-ELCAP). The Review Committee reported, among other things, that the I-ELCAP lacked positive confirmation of valid informed consent for all subjects at all sites by the coordinating center.
The information contained in the Review Committee’s report raises issues that cannot be fully investigated by the journal. We have therefore referred this matter to the Department of Health and Human Services Office for Human Research Protections.
Based on the information we have received thus far, we are issuing this Expression of Concern to alert our readers.
The notice also refers to an April 11, 2008 Publisher’s Note about the study that detailed a number of financial conflicts of interest, including patent applications, that Henschke had failed to disclose when she submitted the papers.
The 2000 paper has been cited 62 times, according to Thomson Scientific’s Web of Knowledge, while the 2001 paper has been cited 267.
A separate 2010 study by the National Cancer Institute, the National Lung Screening Trial, validated the general principle behind the I-ELCAP trial.
We’ll update this post as we learn more.