The idea behind the research — by Robert Getzenberg and colleagues at Johns Hopkins — was to find an alternative to the prostate specific antigen (PSA) test, which many urologists recommend, but which many groups — including the US Preventive Services Task Force — find wanting. The work gave rise to a company, Onconome, Science reported in a 2009 story about the lawsuits:
According to the Pitt complaint, in 2001 while at Pitt, Getzenberg told Onconome’s potential investors that nuclear proteins from prostate tumor cells could be detected in blood and offered an alternative to the prostate specific antigen test, which has well-known limitations. Onconome was founded in 2001 to develop antibody-based tests that detect one such protein, which Getzenberg discovered and called Early Prostate Cancer Antigen (EPCA). The company “depended entirely” on Getzenberg to conduct its scientific research through research agreements with Pitt and later JHU, the suit says.
Things seemed to go well, Science reports, until some of the data were peer-reviewed:
In more than 20 updates to Onconome’s board, the Pitt suit says, Getzenberg reported results for EPCA and biomarkers for other cancers that he described as “amazing”: sensitivities and specificities approaching 100%, which means that the tests identified nearly all cancerous samples and rarely resulted in false positives. Two top medical journals rejected a paper by Getzenberg on a second biomarker called EPCA-2, the suit says.
The paper — now retracted — was finally published in Urology:
It drew widespread media coverage, thanks to a press release from JHU, where Getzenberg had moved in 2005 to take over for [Hopkins cancer biologist Donald] Coffey as research director of the James Buchanan Brady Urological Institute.
A deeper look, however, failed to support that excitement, in phrasing that’s more harsh than that of the eventual retraction notice:
When Onconome hired its own scientists to develop and market the EPCA tests, they were unable to replicate Getzenberg’s experiments. The Pitt suit says that when Onconome compared lab records that were “only recently obtained,” it found that many statements from Getzenberg were “false.” The suit alleges that he exaggerated statistical associations, “cherry-picked the data” to report favorable results, that his technician broke the blind on samples, and that he falsely claimed to have determined the DNA sequence coding for EPCA. In the end, the suit claims, EPCA markers “were and are imaginary.”
The now-retracted study has been cited 67 times, according to Thomson Scientific’s Web of Knowledge. Here’s the retraction notice, which was posted on October 3 of last year and refers to serious problems with the data:
This article has been retracted at the request of the authors. They believe that the article contains findings that may be unreliable. As the authors re-reviewed the data points presented in the article, they identified differences between some of the plate reader values and those that were reported in the article. For some of the duplicates run, one of the values was indeed from the plate reader data, whereas the source of the counterpart value is not easily apparent. Therefore, because the authors could not replicate some of the counterpoint values, they cannot state if the data points represent the actual data generated in the experiments described. Furthermore, the duplicate values may not have been handled in the manner described within the Materials and Methods section of the paper and the values were not blanked. Taken together, the inconsistencies in validating the data collection and recordation warrant retraction of the article. The authors sincerely apologize for any inconvenience this might cause.
The suits were settled for an undisclosed amount, ScienceInsider reported in 2010. We asked Hopkins whether this retraction was a condition of the settlement, but the university said the terms were confidential. We’ve also tried contacting Getzenberg, and the journal, and will update with anything we learn.