BICO has been in the news lately, not in a good way, with regard to a lawsuit by Redmond, Wash.-based Onconome brought against the university and Dr. Robert H. Getzenberg (now at Johns Hopkins, also being sued). Buyer Beware comments on The Scientist coverage of this incident actually sum up much of my thoughts on the matter: that, although universities own the data generated by faculty, staff, and students, no university can be held accountable for their veracity nor be expected to pay for the costs of replicating or confirming these data. As Buyer Beware notes, in this case (which may or may not involve misconduct), the company should have done so prior to significant investment.
Science offers a bit more coverage:
The company “depended entirely” on Getzenberg to conduct its scientific research through research agreements with Pitt and later JHU, the suit says.
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. However, he published a paper on EPCA-2 in the April 2007 issue of Urology. It drew widespread media coverage, thanks to a press release from JHU, where Getzenberg had moved in 2005 to take over for Coffey as research director of the James Buchanan Brady Urological Institute.
When Onconome hired its own scientists to develop and market the EPCA tests, they were unable to replicate Getzenberg’s experiments. …
The lawsuit filed in federal court in Pittsburgh and a similar amended complaint filed in circuit court in Baltimore City in July against JHU and Getzenberg include claims of fraud, breach of contract, and “failure to supervise.” Onconome, which says its losses exceed $13 million, asks for damages to be determined at trial and attorney’s fees. …
Thankfully, US taxpayers, who have made a considerably larger investment than $13M, are not suing over federally funded studies that looked so promising at first but did cure cancer or solve world hunger.
Science also notes that Pitt is not conducting an investigation for possible scientific misconduct, while Johns Hopkins did not comment.
Interestingly, two Canadians, Donald Weaver and Christopher Barden, discuss in a letter to Nature the overlooked value in citing patents in the biomedical literature. They examined “all citations in the reviews, articles and letters/reports in Nature (1,773 citations) and Science (1,367)” for the month of December 2008 and found no patent citations. Their rationale for bringing up this issue is that “Patents present novel, rigorously reviewed unpublished work, as well as providing an unmatched resource for detail.” As the BICO case demonstrates, however, a rigorously reviewed novel method will not necessarily generate the anticipated results.
And of course, thinking about companies and universities unable to replicate highly touted methods and their outcomes brings to mind another scientist whose star has fallen, Homme Hellinga, whom, according to recent comments here about an upcoming PNAS paper, we will soon see garnering the sort of headlines Duke would prefer he not (and apparently, per another comment, would prefer to pretend he is not).