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Onconome Sues Researcher, Pitt, and Hopkins for Alleged Research Fraud over Prostate Biomarkers

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By Ben Butkus

In vitro diagnostics company Onconome has filed a pair of lawsuits against the University of Pittsburgh, one of its former faculty members, and his current employer, Johns Hopkins University, for research fraud and breach of contract related to prostate cancer biomarkers discovered by the scientist.

The most recent suit, filed last week, alleges that the researcher, Robert Getzenberg, misrepresented and falsified data related to the biomarkers after Onconome sponsored "millions of dollars" of research over five years in Getzenberg's labs at Pitt and Johns Hopkins to see if the technology could be developed into a clinical diagnostic test for prostate cancer.

The case, filed in the US District Court for the Western District of Pennsylvania, names both Getzenberg and Pitt as defendants. The other suit, filed in February in the Circuit Court for Baltimore City, names Getzenberg, Pitt, and Johns Hopkins as defendants.

In its Pennsylvania suit, a copy of which was obtained by BTW, Onconome claims Getzenberg submitted data to it claiming that various immunoassays for prostate and other cancers based on the biomarker worked, were reproducible, and demonstrated sensitivities and specificities approaching 100 percent.

Onconome was founded in 2001 to market and sell these immunoassays, which were based on biomarkers discovered by Getzenberg. Instead, Onconome said, the assays were eventually revealed to be "no more accurate in distinguishing cancerous tissue from normal tissue than flipping a coin."

Overall, the company said that it has suffered more than $13 million in direct losses due to the alleged data falsification.

Neither Getzenberg nor representatives from Onconome could be reached for comment. Spokespeople from both Pitt and Johns Hopkins told BTW that the policy of their respective institutions is to refrain from commenting about ongoing litigation.

At the heart of the dispute are biomarkers based on nuclear matrix proteins and dubbed early prostate cancer antigen (EPCA) and EPCA-2, which Getzenberg first developed as a graduate student at Johns Hopkins and later as a faculty member at Pitt.

Getzenberg was part of the team that originally discovered the consistent presence of certain nuclear matrix proteins in prostate cancer tissues. He obtained his PhD from Johns Hopkins in 2002 and later that year joined Pitt. He eventually became co-director of the Pitt Cancer Institute’s Prostate and Urologic Cancer Center, and professor of urology, pathology, and pharmacology at the Pitt School of Medicine.

Getzenberg left Pitt in 2005 to rejoin the Johns Hopkins faculty. He is currently director of research at the James Brady Urological Institute and is a professor of urology at the JHU School of Medicine.

According to the Pennsylvania complaint, Onconome entered into a series of research and licensing agreements beginning in 2002 with Pitt and later with Johns Hopkins. Getzenberg was principal investigator on both sets of agreements.

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Under these agreements, Onconome funded research and development work in the Pitt and JHU laboratories relating to nuclear matrix proteins as prostate cancer biomarkers, and paid for various patent applications surrounding the work, the lawsuit alleges.

In return, Onconome retained the exclusive right to market any biomarkers in commercial applications. In addition, Onconome agreed to pay maintenance fees, minimum royalties, milestone, and other payments based on future sales to the licensing institutions, according to the suit.

Between 2002 and the end of 2008, Onconome spent "many millions of dollars in fulfilling its commitments under these agreements … [and] spent millions of dollars more ramping up its capacity to make and market the biomarkers," the company said.

Over this same period, Onconome alleges, Getzenberg communicated to Onconome in various research updates that, among other achievements, his lab had identified human proteins that distinguished benign from cancerous prostate tissue; that subsequent biomarkers identified in his lab had unusually high specificity and sensitivity; and that his lab had sequenced some or all of these biomarker proteins.

In its suit, Onconome alleges that all of these communications were false. The company alleges that, in laboratory notebooks that it did not obtain until very recently, various members of Getzenberg's lab recorded in their notes results that were inconsistent with Getzenberg's claims, and that Getzenberg "cherry-picked" data to support his various claims. Overall, the company cited more than two dozen specific instances of Getzenberg misrepresenting data between 2002 and 2008.

Onconome alleges that it began to doubt the veracity of Getzenberg's claims in 2007 after in-house and other scientists were unable to replicate his results, and when The Lancet rejected a research paper submitted by Getzenberger.

Onconome named Pitt as a co-defendant in that suit because the university allegedly did not fulfill its obligations under its research agreement and did not sufficiently supervise Getzenberg's research, according to the complaint.

It is unclear whether these allegations appear in Onconome’s February suit naming Johns Hopkins as a co-defendant. BTW was unable to obtain the court documents before press time. The Johns Hopkins spokesperson told BTW this week that this suit is ongoing, and that Johns Hopkins has filed a counterclaim brief, but not a countersuit, in the proceedings.

"Pitt and Dr. Getzenberg benefited directly and substantially from the misrepresentation, fraud, and bad faith of Dr. Getzenberg," Onconome said in the most recent complaint. "Pitt received millions of dollars from Onconome, in the form of payments for the research performed by Dr. Getzenberg and his lab, and in the form of payments for patent licenses. Onconome, thereby, funded the prominent laboratory of Dr. Getzenberg for years, first at Pitt and then at JHU.

"Had Dr. Getzenberg not misrepresented the progress and promise of his research, Onconome’s payments, and the revenues to Pitt and JHU, would have ceased," the suit continues. "As to each of the misrepresentations alleged in this complaint, that representation was a substantial factor in inducing Onconome to take the actions in detrimental reliance that followed that representation in time."

Overall, Onconome said that it has lost more than $13 million as a direct consequence of the defendants’ alleged misrepresentations, and said other "consequential damages” will be established at trial. A court date has not been set.

In June, prior to Onconome's lawsuit, Pitt filed a lawsuit against the company for allegedly failing to pay various maintenance and other fees as stipulated in the contract between the two entities. Pitt voluntarily dismissed the suit in July for unknown reasons.

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